condition - osmosis skin care

International Research Services, Inc.

CLINICAL RESEARCH REPORT

An Eight-Week Clinical Study to Evaluate the Efficacy of a Regimen of Topical Products on Skin Condition

Protocol Number: 3931OSM0415

Sponsor: Osmosis, LLC

Issued To: Ben Johnson, MD CEO Osmosis, LLC 30746 Bryant Drive Unit #410 Evergreen, CO 80439 Phone: 303.674.7660 E-Mail: [email protected]

Date of Issue: October 21, 2015

Study Site:

International Research Services, Inc. 222 Grace Church Street Port Chester, NY 10573 Phone: 914.937.6500 Fax: 914.937.8067

Stephen R. Schwartz IRSI President, CEO E-Mail: [email protected]

Principal Investigator:

Robert J. Frumento IRSI VP Clinical and Corporate Operations E-Mail: [email protected]

Study Coordinator:

Robigaile W. Atienza, CCRC IRSI Study Coordinator E-Mail: [email protected]

Study Schedule Initiation: Screening/ Washout June 8, 2015

Completion: Week 8 August 10, 2015

Product: Purify #OS-PRD-PUR-200; Catalyst AC–11 #OS-PRD-CAC-030; Spritz Clear Plus #OS-PRD-CLR-100; Quench Plus #OS-PRD-QUE-031

IRSI, Inc. Protocol No. 3931OSM0415 FINAL Report Ver. 2.2 October 21, 2015

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Study Summary

Title An Eight-Week Clinical Study to Evaluate the Efficacy of a Regimen of Topical Products on Skin Condition

Protocol Number 3931OSM0415

Sponsor Osmosis, LLC

Methodology Monadic

Objective To evaluate the efficacy of one product to improve skin appearance and condition

Number of Subjects 30 to complete, target enrollment 35

Target Population Female subjects, age 35-59 years old

Duration 8 Weeks + 1 week washout (Screening/Washout (T-7D), Baseline, Week 1, Week 4, Week 8)

Claims

Claims to be assessed immediately after application of the Catalyst AC-11 product and after prolonged use of the topical product regimen

Claim Support

Reduces capillary redness and capillary visibility

Expert Clinical Grading SIAScope Subjective Questionnaires Photo Documentation (n=5)

Improves skin elasticity and firmness

Expert Clinical Grading (elasticity only) Subjective Questionnaires Cutometer

Improves eyelid laxity Expert Clinical Grading Subjective Questionnaires Photo Documentation (n=5)

Improves the appearance of lines/wrinkles

Improves skins overall appearance, radiance and luminosity

Study Products

Name Formula Number

Purify OS-PRD-PUR-200

Catalyst AC - 11 OS-PRD-CAC-030

Spritz Clear Plus OS-PRD-CLR-100

Quench Plus OS-PRD-QUE-031

Supportive Products Dove Beauty Bar, White Purpose Dual Treatment Moisture Lotion with SPF 15

NA NA

Statistical Methodology

Descriptive statistics reported for demographics, instrumental and visual assessments. Monadic data analyses will use paired t-test to determine significance of change from Baseline. Questionnaire response frequencies and mean indicated percent improvement reported for each question. All final statistical analyses will be performed on the PP population, significance set at p≤0.05.

Study Schedule Initiation: Consent / Washout June 8, 2015

Baseline June 15, 2015

Week 1 June 22, 2015

Week 4 July 13, 2015



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Summary This was an eight-week, monadic evaluation of the immediate effects of one test product on the condition and appearance of facial skin and of the long-term effects of a test product regimen on the condition and appearance of facial skin. A study panel of 33 subjects was enrolled in the study and completed participation.

Under the conditions of this study, under the conditions of this study, use of Catalyst AC–11 #OS-PRD-CAC-030 alone and of a regimen consisting of Purify #OS-PRD-PUR-200; Catalyst AC–11 #OS-PRD-CAC-030; Spritz Clear Plus #OS-PRD-CLR-100; Quench Plus #OS-PRD-QUE-031 led to significant improvements in skin appearance and condition as evidenced by results from expert clinical grading, instrumental assessments and subjective questionnaire results. See Section 20.0 Conclusion for further detail.


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Table of Contents

1.0 Introduction ............................................................................................................................................ 7

2.0 Objectives................................................................................................................................................ 7

3.0 Study Design ............................................................................................................................................ 7

4.0 Product .................................................................................................................................................... 8

5.0 Population ............................................................................................................................................... 9

6.0 Methods ................................................................................................................................................ 11

7.0 Procedure .............................................................................................................................................. 14

8.0 Concomitant Medications and Products .............................................................................................. 16

9.0 Adverse Events ...................................................................................................................................... 17

10.0 Institutional Review Board .................................................................................................................. 17

11.0 Informed Consent ............................................................................................................................... 17

12.0 Discontinuation of Study ..................................................................................................................... 17

13.0 Changes to the Protocol ...................................................................................................................... 17

14.0 Monitoring .......................................................................................................................................... 18

15.0 Recording of Data ............................................................................................................................... 18

16.0 Quality Control and Quality Assurance ............................................................................................... 18

17.0 Ethics ................................................................................................................................................... 18

18.0 Statistical Methods ............................................................................................................................. 18

19.0 Results ................................................................................................................................................. 20

20.0 Conclusion ........................................................................................................................................... 29

Appendices Appendix I Protocol Appendix II Protocol Deviations Appendix III Adverse Events Appendix IV Data Listing and Statistical Report


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List of Abbreviations

AE BL C cm CRF CFR D FDA GCP HIPAA ICF ICH IND IRB IRSI AIDS n NDA PI PP SAE SOP T15m TEWL US VAS

Adverse Event Baseline Collect Centimeter Case Report Form Code of Federal Regulations Dispense Food & Drug Administration Good Clinical Practices Health Insurance Portability and Accountability Act Informed Consent Form International Conference on Harmonization Investigational New Drug Institutional Review Board International Research Services, Inc. Acquired Immunodeficiency Syndrome Number of Subjects New Drug Application Principal Investigator Per-Protocol Serious Adverse Event Standard Operating Procedure 15 minutes post initial product application Trans-Epidermal Water Loss United States Visual Analogue Scale


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1.0 Introduction

This document is a report for a human research study. This study was conducted according to International Research Services, Inc. research policies and Standard Operating Procedures, U.S. and international standards of Good Clinical Practice (FDA and ICH guidelines) and applicable government regulations.

2.0 Objectives

2.1 Primary Objective

The efficacy of a topical product regimen, including four products intended to improve facial skin appearance and condition, was evaluated by this study.

2.2 Secondary Objective

The immediate efficacy of one topical product intended to improve facial skin appearance and condition was evaluated by this study.

3.0 Study Design

This was an eight-week monadic clinical study to evaluate an individual product’s immediate effects and a topical product regimen’s effects after one, four and eight weeks of use. Data were analyzed for signs of improvement in facial skin condition and appearance in female subjects who have photodamaged skin. Assessments included expert clinical visual grading, instrumental assessments and photographic documentation. Subjects’ perception of product effects was captured via subjective questionnaire. The treatment products were used daily per Sponsor instructions by all subjects for eight weeks. Thirty-three (33) subjects completed study participation. The study was preceded by a one-week washout period, within which subjects discontinued use of all facial cleansers and moisturizers and used only support product on their faces, as directed by IRSI.

Study visits occurred at Screening/ Washout (T-7D), Baseline (BL), Immediate (T15m) and at Weeks 1, 4 and 8 (W1, W4 and W8). A detailed outline of study visits appears in Section 7.0 of the protocol (Appendix I).

3.1 Claims:

Assessment and questionnaire data were analyzed with particular regard to the following desired key product effects for the regimen of four products after prolonged use:

1. Reduces capillary redness and capillary visibility, as determined by expert clinical grading, SIAScope, subjective questionnaires and photo documentation.

2. Improves elasticity and firmness, as determined by expert clinical grading (elasticity only), Cutometer and subjective questionnaires.

3. Improves eyelid laxity, as determined by expert clinical grading, subjective questionnaires and photo documentation.

4. Improves the appearance of lines/wrinkles, as determined by expert clinical grading, subjective questionnaires and photo documentation.


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5. Improves skins overall appearance, radiance and luminosity, as determined by expert clinical grading, subjective questionnaires and photo documentation.

3.2 Claims (Catalyst AC-11)

Assessment and questionnaire data were analyzed with particular regard to the following desired key product effects for the Catalyst AC-11 cream after a single application:

1. Immediately reduces capillary redness and capillary visibility, as determined by expert clinical grading, subjective questionnaires and photo documentation.

2. Immediately improves eyelid laxity, as determined by expert clinical grading, subjective questionnaires and photo documentation.

3. Immediately improves elasticity and firmness, as determined by expert clinical grading (elasticity only), Cutometer and subjective questionnaires (elasticity only).

4. Immediately improves the appearance of lines/wrinkles, as determined by expert clinical grading, subjective questionnaires and photo documentation.

5. Immediately improves skins overall appearance, radiance and luminosity, as determined by expert clinical grading, subjective questionnaires and photo documentation.

4.0 Product

All products were provided by the Sponsor and were labeled with appropriate codes and proper use instructions. Supportive product(s) were provided by IRSI. Upon receipt, product was logged in and stored in a secure area. Within one month of issuance of the final signed report, unless otherwise instructed in writing, all test products, used and unused, will be destroyed and disposed of in accordance with IRSI’s SOP. Product Descriptions

Name Designation Formula Number Quantity Received

Date Received

Study Product

Purify Cleanser OS-PRD-PUR-200 45 06-04-15

Catalyst AC-11 Gel OS-PRD-CAC-030 85 06-04-15

Spritz Clear Plus Enhancer OS-PRD-CLR-100 45 06-04-15

Quench Plus Moisturizer OS-PRD-QUE-031 85 06-04-15

Supportive Products

Dove Beauty Bar, White Washout Cleanser

NA

Purpose Dual Treatment Moisture Lotion with SPF 15

SPF Moisturizer

NA

4.2 Product Use Instructions

Subjects were provided with Support Washout Cleanser and SPF Moisturizer approximately seven days before Baseline.

At Baseline, subjects discontinued use of the Support Washout Cleanser and SPF Moisturizer and were provided with the test product regimen to use for the duration of the study.


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At the Baseline visit, all subjects applied the Catalyst AC-11 product only to the face following Sponsor instructions under IRSI technician supervision. Sponsor-provided use instructions were explained to subjects and were provided to each subject in their printed Study Instructions (See Appendix I Protocol, Appendix I).

Test Product Directions:

Use the test products twice daily, morning and evening in the following sequence:

Step 1: Wash face with Purify:

Apply ½ pump into palm of hand and lather face and neck with warm water, thoroughly Cleanse and rinse until all product has been removed. Dry skin with a soft towel.

Step 2: Apply Catalyst AC-11

Apply two pumps into hand and massage onto face and neck thoroughly. Massage into skin thoroughly.

Step 3: Spritz Clear Plus:

Spray Clear Plus 3-5 times onto face and neck and massage skin again until all product is absorbed into skin. This step is essential to ensure Catalyst AC-11 is fully absorbed.

Step 4: Quench Plus:

Apply 1-2 pumps Quench Plus into hand and massage onto entire face and neck. Support Product Directions:

Washout Period (T-7d):

Washout Cleanser: Use daily in place of your normal facial cleanser.

SPF Moisturizer: Apply daily in the morning prior to sun exposure, reapply every 2 hours as needed throughout the day during sun exposure during the washout period.

Study Period: Per sponsor, no sunscreen is permitted for use during study period.

Avoid sun exposure to the face, no sunscreen use is permitted, use hats and/or umbrellas when going into sun.

5.0 Population

5.1 Sample Size

The sample size of n=30 was requested by the Sponsor. A total number of 33 subjects were enrolled in the study and completed participation.

5.2 Inclusion Criteria

1. Females, in good general health, and between the ages of 35 and 59 years old, inclusive, at time of enrollment.

2. Subjects with lines and wrinkles and eyelid laxity as determined by an expert grader at Baseline.

a. Score of ≥2 cm on 10 cm VAS for fine lines/wrinkles (crow’s feet)


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b. Score of ≥2 cm on 10 cm VAS for eyelid laxity 3. A portion of the panel (approximately n=10) with Capillary visibility (telangiectasia)

a. Score of ≥2 cm on 10 cm VAS for capillary visibility 4. A portion of the panel (approximately n=10) with actinic keratosis as determined by an

expert grader at baseline. a. Score of ≥2 cm on 10 cm VAS for actinic keratosis severity

5. Willing to be photographed and sign a photograph release form. 6. Able to read, understand and willing to sign an ICF, including HIPAA and state requirements,

complete a brief personal/medical history 7. Dependable and willing to attend study visits and comply with all study instructions and

requirements, including but not limited to: a. Willing to abstain from any other superficial or deep facial procedure during the

study (dermabrasion, microdermabrasion, peels, photo facials, laser treatment, facial lesion removal, etc.).

b. Willing to abstain from use of all other topical products for the duration of the washout period and study period.

c. Willing to abstain from the use of tanning bed use and recreational sun exposure on the face for the duration of the washout period and study period.

5.3 Exclusion Criteria

1. Subjects using systemic or topical steroids, Accutane, oral or topical estrogens, and/or other

medicines affecting skin in a major way during study period or washout period.

2. Subjects with present or previous inflammatory or other skin diseases, such as rosacea,

severe acne, Systemic Lupus Erythematosus (SLE), dermatomyositis, scleroderma, etc.

3. Current or Smokers within one month prior to enrollment

General exclusion criteria:

4. Subjects participating in any other clinical studies

5. Subjects having an acute or chronic disease or medical condition, including dermatological

problems, which could put her at risk in the opinion of the Principal Investigator or

compromise study outcomes. Typical uncontrolled chronic or serious diseases and

conditions which would prevent participation in any clinical trial are cancer, AIDS, diabetes,

morbid obesity, renal impairment, mental illness, drug/alcohol addiction.

6. Subjects who are unreliable or unlikely to be available for the duration of the study

7. History of allergic reactions, skin sensitization and/or known allergies to cosmetic

ingredients, toiletries, sunscreens, etc.

8. Immunocompromised subjects

9. Woman who started Hormone Replacement Therapy within the last three months preceding

the screening visit

10. Woman using oral contraception for less than three months before the screening visit or who

has changed her contraceptive method within the three months before the Baseline visit or

planning to modify her contraception treatment within the duration of the study


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11. Woman known to be pregnant, lactating or planning to become pregnant within six months.

Subjects who become pregnant during the study must inform the Principal Investigator

immediately

12. Individuals unable to communicate or cooperate with the Principal Investigator due to

language problems, poor mental development, or impaired cerebral function

13. Employees of IRSI or other testing firms/ laboratories, cosmetic or raw goods manufacturers

or suppliers

6.0 Methods

This study was performed in accordance to IRSI final signed clinical study protocol number 3931OSM0415 version 2.6 dated June 29, 2015 and outlined below.

6.1 Expert Grading Assessments for Efficacy

Visual Analog Scales (VAS) are commonly used in clinical research to measure intensity or frequency of various symptoms, subjective characteristics or attitudes that cannot be directly measured. VAS are a reliable scale and more sensitive to small changes than simple ordinal scales. When responding to a VAS item, the expert grader specifies their level of agreement to a statement by indicating a position along a line (10 cm) between two end-points or anchor responses. Simple VAS was used to evaluate efficacy parameters in which the ends of a 10 cm horizontal line were defined as extreme limits orientated from the left (best) to the right (worst).

All subjects had facial skin texture /smoothness (visual), lines/wrinkles (crow’s feet), elasticity (tactile), eyelid laxity, radiance/luminosity, and overall appearance assessed by an expert grader at BL, T15m, W1, W4 and W8. A portion of the panel which presented with capillary visibility and Actinic Keratosis at Baseline were assessed by an expert grader for these attributes at BL, T15m, W1, W4 and W8, with n=19 presenting with Capillary Visibility and n=14 presenting with Actinic Keratosis.

The same expert grader assessed the same subjects at every time point. Clinical grading was performed in the same room at each study visit using overhead lighting as well as a lighted magnifying loop as needed. Natural sunlight was blocked from the room to ensure the same lighting conditions at each time point.

The following IRSI-developed VAS were used:

Texture / Smoothness - Visual

0 cm 10 cm Smooth, even

surface appearance

Rough, uneven surface

appearance


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Fine Lines/Wrinkles (Crow’s Feet)

0 cm 10 cm

None

Numerous lines/ Wrinkles –

Severe, Deep

Radiance / Luminosity

0 cm 10 cm Radiant,

Luminous appearance

Dull/Matte

and/or Sallow

Eyelid Laxity

0 cm 10 cm Taut,

“awake”, smooth eyelid

Sagging, “tired”,

drooping eyelid

Elasticity (tactile)

0 cm 10 cm Good

Stretch and Bounce back

Poor Stretch and Bounce

back

Overall Appearance

0 cm 10 cm Vibrant, Healthy

appearance

Aged, Unhealthy

appearance

Capillary Visibility*

0 cm 10 cm

None *Only graded on n=19 subjects which presented this at Baseline

(portion of panel)

Highly visible,

intense red capillary


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Actinic Keratosis Severity*

0 cm 10 cm

None *Only graded on n=14 subjects which presented this at Baseline

(portion of panel)

Highly visible patches

6.2 Instrumental Evaluations

Test environment temperature (°F) and humidity (%) was recorded in every room used for study conduct every hour. Additionally, once-daily outdoor conditions were recorded for each visit, this data is filed in the on-site study file and available to the sponsor upon request.

6.2.1 COSMETRICS™ SIAscope

The COSMETRICS™ SIAScope (Astron Clinica, Toft, UK) is a non-invasive optical skin imaging instrument using Spectrophotometric Intracutaneous Analysis (SIA), or chromophore mapping. The technique is based on a unique combination of dermatoscopy and contact remittance spectrophotometry. The hardware consists of a hand-held imaging probe attached to a laptop computer. The unit is placed in contact with the skin surface and high-intensity LED’s illuminate the skin as discreet wavelengths of 400 to 1000nm, spanning the visible spectrum and a small range of the near infrared spectrum. A digital image is captured for each wavelength.

Three parametric chromophore maps are retrieved up to 2 mm in depth and 11 mm in circumference, one for each of the following parameters: epidermal melanin, dermal hemoglobin and dermal collagen.

For this study, dermal hemoglobin measurements were taken in duplicate and averaged on a spot determined at Baseline with visible red capillaries if applicable or on the cheek if no capillaries visible, at BL, W1, W4 and W8. The same location was measured at each time point and recorded using a face map.

6.2.2 CUTOMETER

The Cutometer MPA 580 (Courage + Khazaka, Germany) measures the viscoelastic properties of the skin by applying suction to the skin surface, drawing the skin into the aperture of the probe and determining the penetration depth using an optical measuring system.

The resistance of the skin to be sucked up by the negative pressure (firmness) and its ability to return to its original position (elasticity) are calculated and displayed as curves. The Cutometer outputs include many parameters of different portions of the measurement curve including of R0 (Uf, firmness), R2 (Ua/Uf, gross elasticity), R5 (Ur/Ue, net elasticity), R7 (Ur/Uf, elastic portion) and R9 (R3[last max amp]-R0[Uf], fatigue).

Skin Elasticity is reported using the R5 (Ur/Ue) parameter, as the skin becomes more elastic this value will increase. Skin Firmness is reported using the R0 (Uf) parameter, as the skin becomes firmer this value will decrease.


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All subjects had Cutometer measurements taken on their left or right cheek, as determined by a randomization code, in duplicate and averaged at BL, T15m, W1, W4 and W8. Assessment location was recorded on a face map for each subject.

6.3 Photography

All clinical photography was performed in accordance with IRSI’s SOP to ensure reproducibility of high quality images throughout the duration of the study. Imaging was conducted in a designated photography suite with a matte black wall and all natural light is blocked out. To prepare subjects for clinical photography, subjects were asked to remove all jewelry, including earrings, necklaces and any facial jewelry. A trained technician inspected the subjects under a lighted magnification loop to ensure no residual color cosmetics or skincare products were visible on the face, eyes or lips. Subjects were provided with a black cape and black headband and instructed on placement to ensure all hair is pulled back neatly and covered.

6.3.1 Clarity™ 2D Research System Ti

The Clarity™ 2D Research System Ti (Clarity) (BrighTex Bio-Photonics (BTBP), San Jose CA, USA) captures high quality full face frontal, left and right lateral images. Three cameras within the system allow for 18 megapixel SLR image capture in 16-bit simultaneously using a live feed display and automated facial alignment checks against baseline images for reproducibility.

A subgroup of five (N=5) subjects chosen at random had Left, Right and Center facial images captured at BL, W1, W4 and W8. Photographs are for documentation purposes only.

6.4 Subjective Questionnaire

Subjective questionnaires allow the Sponsor to gauge the subjects’ opinions of the test product and its effects. Questions asked for subjects’ agreement to a statement with a five point scale, IRSI provided questionnaire and performed analysis (See Appendix I Protocol, Appendix II).

Subjects completed the questionnaire at T15m regarding Catalyst AC-11 immediate effects and again at W1, W4 and W8 regarding prolonged use of the four product regimen.

7.0 Procedure

7.1 Consent / Screening Visit / Washout

Potential subjects came to the clinic approximately seven days prior to the Baseline visit to read and sign an informed consent form (ICF), as described in Section 11, a model release form, inclusion / exclusion criteria and to complete a brief personal/medical history.

Unless a response(s) on their medical history form, inclusion / exclusion criteria or ICF indicate that they are not qualified to participate in the study, each potential subject received the support Washout Cleanser and Washout SPF Moisturizer and instructions for its use during the seven-day washout period.

They then received an appointment time for their Baseline visit and were dismissed from the consent / screening / washout visit.


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7.2 Baseline Visit

Subjects arrived at IRSI with clean facial skin, having washed their face and applied no topical treatment or cosmetic products within one hour prior to their visit.

Potential subjects acclimated to clinic environment with their facial skin exposed for at least 15 minutes allowing subject to relax and let their skin balance to the environment.

Following acclimatization, potential subjects were screened to determine if they meet study entrance criteria as described in Section 5.2 and 5.3.

The following Screening procedures were performed and all findings reported on the appropriate CRFs:

- Review of compliance to washout, updated Medical History and inclusion / exclusion criteria.

- Expert visual evaluation for any skin condition which would disqualify subject from study enrollment.

- Expert visual evaluation for qualification according to inclusion criteria 4.a and 4.b, above, in section 5.2.

Subjects who met entrance criteria as defined in Section 5.2 and 5.3 were enrolled and proceeded with study participation.

The following BL assessments were performed and all findings reported on the appropriate CRFs:

- Expert visual grading as described in Section 6.1 - Instrumental assessments as described in Section 6.2 - Photography as described in Section 6.3

All subjects were provided with the test product regimen along with instructions and diary to record use per section 4.2.

Subjects applied the Catalyst AC-11 product to their face under supervision as described in Section 4.2.

Approximately 15 minutes post-application the following T15m assessments began and all findings were reported on the appropriate CRFs:

- Expert visual grading as described in Section 6.1 - Instrumental assessments as described in Section 6.2 - Subjective Questionnaire as described in Section 6.4

Subjects were advised to inform the laboratory immediately if any adverse reactions were experienced during the study.

After all evaluations are completed, subjects were given an appointment time for their Week 1 visit and dismissed from the Baseline visit.

7.3 Week 1, 4 and Week 8 Visits

Subjects arrived at IRSI with clean facial skin, having washed their face and applied no topical treatment or cosmetic products within one hour prior to their visit.

Review of compliance to study instructions, updated Medical History Subjects acclimated to clinic environment with their facial skin exposed for at least 15 minutes

allowing subject to relax and let their skin balance to the environment. The following assessments were performed and all findings reported on the appropriate CRFs:



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- Subjective Questionnaires as described in Section 6.4 Each subject’s products were inspected to ensure product use compliance and/or that enough

product remains for study duration, and diaries were reviewed and/or subjects queried to detect any changes in subject’s health.

At W1 and W4, subjects were advised to inform the laboratory immediately if any adverse reactions were experienced during the study.

At W1 and W4, after all evaluations are completed, subjects were given an appointment time for their next visit and dismissed.

At W8, subjects were advised to inform the laboratory immediately if any adverse reactions were experienced during the 48 hours following study completion.

At W8, after all evaluations are completed, subjects returned any unused products and/or empty containers and were given a stipend for their participation and dismissed from the study.

7.3.1 Procedure Summary Table

Procedures Screening/ Washout Baseline

Immediate Week 1 Week 4 Week 8

Study Initiation and Qualification

Informed Consent and Medical History

X

Inclusion/Exclusion Criteria reviewed

X X

Dispense/ Collect Products D

Support D

Test

C

Expert Clinical Grading

- Texture (visual) -Lines/Wrinkles (Crow’s Feet) - Radiance/ Luminosity -Eyelid Laxity -Elasticity -Overall Appearance -Capillary Visibility - Actinic Keratosis Severity

X X X X X

Instrumental Evaluation

SIAScope (hemoglobin)

X

X X X

Cutometer (elasticity,

firmness) X

X X X X

Photography Clarity 2DResearch Ti (n=5, L, R,C views)

X

X X X

Consumer Perception

Subjective Questionnaire

X

Catalyst AC-11 only

X X X

8.0 Concomitant Medications and Products

The use of any topical skin treatment products (other than those assigned during the study) on the face was prohibited during the washout and study periods. This included, but was not limited to moisturizers, serums, cleansers, sunscreens and medicated creams.


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Use of superficial or deep facial procedures during the study was prohibited including dermabrasion, microdermabrasion, peels, photo facials, laser treatments, facial lesion removal.

Major medical procedures were prohibited including endoscopy or any procedure requiring sedation.

The use of color cosmetics was allowed, but introduction of new personal care products was prohibited for the duration of the study.

Smoking was prohibited for the duration of the study.

9.0 Adverse Events

One adverse event was reported during the conduct of this study.

1. Subject #33 reported on July 14, 2015 that she had experienced severe nephrolithiasis on July 13, 2015 which necessitated a visit to hospital emergency room. Kidney stones were passed by subject during emergency room visit and subsequent urinalysis results were within normal ranges. Subject was discharged from the hospital emergency room with no follow-up required and no medications prescribed. The event had no relationship to the study product and no further follow-up from clinic staff was deemed necessary.

10.0 Institutional Review Board

IRB review and approval of this study was not requested by the Sponsor.

11.0 Informed Consent

The informed consent process was completed prior to an individual’s involvement in any study related activity. The process was documented using a written informed consent form (ICF) conforming to FDA 21 CFR 50.25 (See Appendix I Protocol, Section 11.0 and Appendix IV).

After review, two copies of the ICF were signed and dated by the individual and the Principal Investigator or his designee administering the consent. One original copy was retained by IRSI and the other was given to the individual.

12.0 Discontinuation of Study

The study was completed on schedule as per the clinical study protocol (and subsequent amendments).

13.0 Changes to the Protocol

13.1 Protocol Amendments

No amendments were made to the final signed protocol for this study.

13.2 Protocol Deviations

Two protocol deviations occurred during the study. See Appendix II for signed protocol deviation form.

1. Minor: Subject # 24 was enrolled at age 60 years, contrary to the protocol, Section 5.2, Inclusion Criteria, number one.


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2. Minor: Subject # 02 did not respond to Question # 13 of the Week 4 Questionnaires as required per protocol.

14.0 Monitoring

The Sponsor did not monitor any portion of this clinical study.

15.0 Recording of Data

All data and information, except electronically recorded data, was recorded on specific paper case report forms (CRFs) as described in the clinical study protocol (See Appendix I Protocol, Appendix III).

16.0 Quality Control and Quality Assurance

This clinical study has been audited by the IRSI Quality Assurance / Quality Control auditor. The auditor verified study for accuracy, consistency and proper documentation in accordance to IRSI SOPs and practices. Additionally, accuracy of results reported in the body of this report with respect to the results reported in the data listings and statistical report (See Appendix II). The data listings and database used for statistical analysis was verified against the CRFs. The data listings were verified against the CRFs for 100% of the data, in a randomly selected set of the subjects (25% of the total number of subjects). The statistical report was validated for accuracy and completeness, as well as verifying the correctness of all subject numbers (n) and the analyses performed according to the Statistical Analysis Plan as described in Section 18 of the clinical study protocol.

17.0 Ethics

The study was conducted in accordance with FDA GCP regulations and ICH guidelines in as much as they apply to cosmetic research with the following noted: This was not an IND / NDA clinical trial. IRSI does not assume any Sponsor obligations as stipulated in FDA GCP and ICH documents. This study is not intended for submission to the FDA.

18.0 Statistical Methods

The planned statistical analysis was performed as outlined in the study protocol for each type of data to be acquired. (See Protocol, Section 18.0)

The per-protocol (PP) population is defined as the subset of subjects that who complied with the protocol sufficiently to ensure that their data will be likely to exhibit the effects of the treatment. To be considered a PP subject, a subject could not miss more than one study visit (excluding Baseline or Week 8) or be found to be non-compliant with the study protocol at the discretion of the Principal Investigator (PI).

The PP population was used for statistical analysis at each time point. Statistical significance was set at p≤0.05.


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Data Type Statistical Method Data Reported

Demographics Descriptive Statistics Mean and standard deviation Min and Max Frequency (number and percent)

Clinical Grading for Efficacy, Instrumental Evaluation

Descriptive Statistics Paired T-test (monadic),

Mean and standard deviation Mean percent improvement from Baseline Percent of subjects improving P-value vs. Baseline

Subjective Questionnaire Descriptive Statistics

Frequency tables (n and %) of each response Percent of subjects responding favorably.


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19.0 Results

19.1 Tables

Enrollment and demographic information is reported below in Tables 1.0-2.0. Expert clinical grading results are included in Table 3.0, instrumental results are included in Table 4.0 and subjective questionnaire results are included in Table 5.0.

Table 1.0 Enrollment Status n

Enrolled 33

Discontinued 0

Completed Baseline time point 33

Completed Week 1 time point 33

Completed Week 4 time point 32 Subject #33 missed the Week 4 visit.

Completed Week 8 time point 33

Table 2.0 Demographics

*See Protocol Deviation #1

Variable n Mean ± SD Min Max

Age (years) 33 51.51 ± 6.80 35 60*

Height (inches) 33 64.18 ± 2.76 59 69

Weight (pounds) 33 166.90 ± 42.91 96 300

n Percent

Ethnicity 33 Hispanic or Latino 6 18.2%

Not Hispanic or Latino 27 81.8%

n Percent

Race 33

African American or Black 1 3.0%

White 27 81.8%

No Response (see Hispanic or Latino above)

5 15.2%

n Percent

Fitzpatrick Skin Type 33

Skin Type I 1 3.0%

Skin Type II 10 30.3%

Skin Type III 15 45.5%

Skin Type IV 6 18.2%

Skin Type V 1 3.0%

n Percent

Facial Skin Type 33

Combination 15 45.5%

Dry 3 9.1%

Normal 14 42.4%

Oily 1 3.0%


CONFIDENTIAL 21

Table 3.0 Experts Clinical Grader Evaluation – Catalyst AC-11 – Monadic, Comparison to Baseline

Assessment Time Point n Mean ± SD Mean Percent Improvement From BL mean

Percent of Subjects Showing

Improvement From BL

P-Value TX vs. BL

Texture/Smoothness (visual)

Baseline 33 4.05 ± 0.49

Immediate 33 3.07 ± 0.55 23.66% 97.0% <0.001*


Baseline 33 4.20 ± 0.86

Immediate 33 3.71 ± 0.77 11.47% 100% <0.001*

Radiance/Luminosity Baseline 33 4.73 ± 0.42

Immediate 33 3.20 ± 0.59 31.52% 93.9% <0.001*

Eyelid Laxity Baseline 33 3.86 ± 0.90

Immediate 33 3.66 ± 0.85 4.59% 72.7% 0.001*

Elasticity (tactile) Baseline 33 3.90 ± 0.36

Immediate 33 3.46 ± 0.35 10.98% 93.9% <0.001*

Overall Appearance Baseline 33 4.80 ± 4.25

Immediate 33 4.25 ± 0.57 11.48% 84.8% <0.001*

Capillary Visibility Baseline 19^ 4.38 ± 0.68

Immediate 19^ 4.14 ± 0.71 5.56% 78.9% 0.001*

Actinic Keratosis Severity

Baseline 14^ 3.59 ± 0.66

Immediate 14^ 3.28 ± 0.58 8.37% 86.7% <0.001* ^Only subjects who present Capillary Visibility and Actinic Keratosis Severity at Baseline were assessed for all visits. NI=No Improvement *Indicates a statistically significant improvement compared to baseline, p≤0.05 **Indicates a statistically significant worsening compared to baseline, p≤0.05


CONFIDENTIAL 22

Table 3.1 Experts Clinical Grader Evaluation – Regimen – Monadic, Comparison to Baseline

Assessment Time Point n Mean ± SD Mean Percent Improvement From BL mean


Improvement From BL

P-Value TX vs. BL

Texture/Smoothness (visual)

Baseline 33 4.05 ± 0.49

Week 1 33 4.27 ± 0.44 NI 42.4% 0.069

Week 4 32 4.12 ± 0.27 NI 59.4% 0.577

Week 8 33 3.59 ± 0.49 10.13% 75.8% <0.001*


Baseline 33 4.20 ± 0.86

Week 1 33 4.66 ± 0.98 NI 18.2% 0.002**

Week 4 32 4.00 ± 0.82 3.80% 62.5% 0.072

Week 8 33 3.48 ± 0.78 16.67% 87.9% <0.001*

Radiance/Luminosity

Baseline 33 4.73 ± 0.42

Week 1 33 4.66 ± 0.57 1.28% 57.6% 0.420

Week 4 32 4.20 ± 0.38 10.84% 84.4% <0.001*

Week 8 33 3.20 ± 0.72 32.00% 100% <0.001*

Eyelid Laxity

Baseline 33 3.86 ± 0.90

Week 1 33 3.78 ± 0.79 NI 51.5% 0.559

Week 4 32 3.50 ± 0.59 5.52% 59.4% 0.009*

Week 8 33 3.23 ± 0.61 14.08% 81.8% <0.001*


Baseline 33 3.90 ± 0.36

Week 1 33 3.89 ± 0.37 NI 39.4% 0.862

Week 4 32 3.97 ± 0.27 NI 31.3% 0.153

Week 8 33 3.50 ± 0.35 9.80% 75.8% <0.001*

Overall Appearance

Baseline 33 4.80 ± 4.25

Week 1 33 4.61 ± 0.35 3.63% 69.7% 0.008*

Week 4 32 4.33 ± 0.35 8.89% 84.4% <0.001*

Week 8 33 3.80 ± 0.51 20.91% 100% <0.001*

Capillary Visibility

Baseline 19^ 4.38 ± 0.68

Week 1 19^ 4.37 ± 0.65 NI 42.1% 0.907

Week 4 18^ 3.92 ± 0.57 11.29% 88.9% <0.001*

Week 8 19^ 3.26 ± 0.61 25.19% 89.5% <0.001*

Actinic Keratosis Severity

Baseline 14 3.59 ± 0.66

Week 1 14^ 3.80 ± 0.66 NI 35.7% 0.284

Week 4 13^ 3.34 ± 0.42 3.29% 53.8% 0.251

Week 8 14^ 2.95 ± 0.52 15.49% 92.9% 0.005* ^Only subjects who present Capillary Visibility and Actinic Keratosis Severity at Baseline were assessed for all visits. NI=No Improvement *Indicates a statistically significant improvement compared to baseline, p≤0.05 **Indicates a statistically significant worsening compared to baseline, p≤0.05


CONFIDENTIAL 23

Table 4.0 Instrumental Evaluation - Catalyst AC-11 – Monadic, Comparison to Baseline

Assessment Time Point n Mean ± SD

Mean Percent

Improvement From BL

mean


Improvement From BL

P-Value TX vs. BL

Cutometer

Firmness (R0 Uf)

Baseline 33 0.23 ± 0.05

Immediate 33 0.24 ± 0.05 NI 45.5% 0.335

Elasticity (R5 Ur/Ue)

Baseline 33 0.39 ± 0.14

Immediate 33 0.40 ± 0.17 2.99% 51.5% 0.787 NI= No improvement *Indicates a statistically significant improvement compared to baseline, p≤0.05 **Indicates a statistically significant worsening compared to baseline, p≤0.05

Table 4.1 Instrumental Evaluation – Regimen – Monadic, Comparison to Baseline

Assessment Time Point n Mean ± SD

Mean Percent

Improvement From BL

mean


Improvement From BL

P-Value TX vs. BL

Cutometer

Firmness (R0 Uf)

Baseline 33 0.23 ± 0.05

Week 1 33 0.24 ± 0.04 NI 33.3% 0.232

Week 4 32 0.22 ± 0.04 1.13% 59.4% 0.227

Week 8 33 0.21 ± 0.04 5.59% 63.6% 0.008*

Elasticity (R5 Ur/Ue)

Baseline 33 0.39 ± 0.14

Week 1 33 0.38 ± 0.07 11.32% 51.5% 0.823

Week 4 32 0.52 ± 0.10 45.00% 84.4% <0.001*

Week 8 33 0.72 ± 0.11 109.85% 97.0% <0.001*

SIAScope Hemoglobin

Baseline 33 470.98 ± 45.00

Week 1 33 569.70 ± 73.71 NI 3.0% <0.001**

Week 4 32 169.20 ± 23.73 63.56% 100% <0.001*

Week 8 33 166.19 ± 29.32 64.25% 100% <0.001* NI= No improvement *Indicates a statistically significant improvement compared to baseline, p≤0.05 **Indicates a statistically significant worsening compared to baseline, p≤0.05


CONFIDENTIAL 24

Table 5.0 Subjective Questionnaire - Catalyst AC-11– Consumer Perception

Question n

Immediate Percent

Responding Favorably

Response n (%) Strongly

Agree Agree Neutral Disagree

Strongly Disagree

1. The product immediately reduced the capillary redness of my facial skin.

33 1 (3.0%) 5 (15.2%) 24 (72.7%) 1 (3.0%) 2 (6.1%) 18.2%

2. The product immediately improved the laxity (droopiness) of my eyelid.

33 1 (3.0%) 8 (24.2%) 21 (63.6%) 1 (3.0%) 2 (6.1%) 27.3%

3. The product immediately improved the firmness of my facial skin.

33 4 (12.1%) 13 (39.4%) 14 (42.4%) 1 (3.0%) 1 (3.0%) 51.5%

4. The product immediately improved the elasticity of my facial skin.

33 4 (12.1%) 16 (48.5%) 11 (33.3%) 1 (3.0%) 1 (3.0%) 60.6%

5. The product immediately lifted my facial skin and improved the appearance of sagging in my face.

33 3 (9.1%) 12 (36.4%) 16 (48.5%) 1 (3.0%) 1 (3.0%) 45.5%

6. The product immediately tightened my facial skin.

33 3 (9.1%) 19 (57.6%) 9 (27.3%) 1 (3.0%) 1 (3.0%) 66.7%

7. The product immediately improved the appearance of lines/ wrinkles on my crow’s feet area.

33 2 (6.1%) 4 (12.1%) 24 (72.7%) 1 (3.0%) 2 (6.1%) 18.2%

8. The product immediately improved the appearance of lines/ wrinkles on my facial skin.

33 1 (3.0%) 4 (12.1%) 25 (75.8%) 1 (3.0%) 2 (6.1%) 15.2%

9. My facial skin appears less dull and more radiant immediately after using the product.

33 1 (3.0%) 16 (48.5%) 13 (39.4%) 2 (6.1%) 1 (3.0%) 51.5%

10. The product immediately improved the appearance of my facial skin, illuminating my complexion with a fresh youth infused glow.

33 2 (6.1%) 12 (36.4%) 16 (48.5%) 2 (6.1%) 1 (3.0%) 42.4%

11. The product immediately enhanced the overall appearance of my facial skin.

33 2 (6.1%) 13 (39.4%) 15 (45.5%) 2 (6.1) 1 (3.0%) 45.5%

12. I did not experience any irritation after product application.

33 13 (39.4%) 11 (33.3%) 7 (21.2%) 1 (3.0%) 1 (3.0%) 72.7%

Question n Response n (%) Percent


Strongly Agree

Agree Neutral Disagree Strongly Disagree

N/A

13. I immediately felt there was a relief in my actinic keratosis (scaly, crusty lesion).

14* 1

(6.7%) 3

(20%) 9

(60%) 2

(13.3%) 0

(0.0%) 19 21.4%

Bold/ Shaded = the majority of subjects responded favorably, >50% *Only subjects included in the Actinic Keratosis group (n=14) were included in the analysis.


CONFIDENTIAL 25

Table 5.0 Subjective Questionnaire – Regimen – Consumer Perception (Continued)

Question n

Week 1 Percent




Strongly Disagree

1. The product reduced the capillary redness of my facial skin.

33 2 (6.1%) 11 (33.3%) 16 (48.5%) 3 (9.1%) 1 (3.0%) 39.4%

2. The product improved the laxity (droopiness) of my eyelid.

33 0 (0.0%) 12 (36.4%) 18 (54.5%) 2 (6.1%) 1 (3.0%) 36.4%

3. The product improved the firmness of my facial skin.

33 3 (9.1%) 20 (60.6%) 9 (27.3%) 0 (0.0%) 1 (3.0%) 69.7%

4. The product improved the elasticity of my facial skin.

33 3 (9.1%) 17 (51.5%) 11 (33.3%) 1 (3.0%) 1 (3.0%) 60.6%

5. The product lifted my facial skin and improved the appearance of sagging in my face.

33 3 (9.1%) 12 (36.4%) 15 (45.5%) 2 (6.1%) 1 (3.0%) 45.5%

6. The product tightened my facial skin.

33 3 (9.1%) 15 (45.5%) 14 (42.4%) 0 (0.0%) 1 (3.0%) 54.5%

7. The product improved the appearance of lines/ wrinkles on my crow’s feet area.

33 1 (3.0%) 13 (39.4%) 16 (48.5%) 2 (6.1%) 1 (3.0%) 42.4%

8. The product improved the appearance of lines/ wrinkles on my facial skin.

33 2 (6.1%) 12 (36.4%) 16 (48.5%) 2 (6.1%) 1 (3.0%) 42.4%

9. My facial skin appears less dull and more radiant after using the product.

33 4 (12.1%) 17 (51.5%) 10 (30.3%) 1 (3.0%) 1 (3.0%) 63.6%

10. The product improved the appearance of my facial skin, illuminating my complexion with a fresh youth infused glow.

33 2 (6.1%) 18 (54.5%) 10 (30.3%) 2 (6.1%) 1 (3.0%) 60.6%

11. The product enhanced the overall appearance of my facial skin.

33 4 (12.1%) 17 (51.5%) 9 (27.3%) 2 (6.1%) 1 (3.0%) 63.6%


33 16 (48.5%) 15 (45.5%) 2 (6.1%) 0 (0.0%) 0 (0.0%) 93.9%



Strongly Agree


N/A

13. I felt there was a relief in my actinic keratosis (scaly, crusty lesion).

14* 3

(20.0%) 4

(26.7%) 6

(40.0%) 1

(6.7%) 0

(0.0%) 19 50.0%

Bold/ Shaded = the majority of subjects responded favorably, >50% *Only subjects included in the Actinic Keratosis group (n=15) were included in the analysis.


CONFIDENTIAL 26


Question n

Week 4 Percent




Strongly Disagree


32 5 (15.6%) 9 (28.1%) 14 (43.8%) 4 (12.5%) 0 (0.0%) 43.8%


32 4 (12.5%) 9 (28.1%) 16 (50.0%) 3 (9.4%) 0 (0.0%) 40.6%


32 4 (12.5%) 18 (56.3%) 7 (21.9%) 2 (6.3%) 1 (3.1%) 68.8%


32 5 (15.6%) 18 (56.3%) 7 (21.9%) 2 (6.3%) 0 (0.0%) 71.9%


32 4 (12.5%) 12 (37.5%) 14 (43.8%) 2 (6.3%) 0 (0.0%) 50.0%


32 5 (15.6%) 17 (53.1%) 8 (25.0%) 2 (6.3%) 0 (0.0%) 68.8%


32 5 (15.6%) 7 (21.9%) 17 (53.1%) 3 (9.4%) 0 (0.0%) 37.5%


32 4 (12.5%) 11 (34.4%) 14 (43.8%) 3 (9.4%) 0 (0.0%) 46.9%


32 6 (18.8%) 17 (53.1%) 7 (21.9%) 2 (6.3%) 0 (0.0%) 71.9%


32 5 (15.6%) 15 (46.9%) 11 (34.4%) 1 (3.1%) 0 (0.0%) 62.5%


32 6 (18.8%) 19 (59.4%) 6 (18.8%) 1 (3.1%) 0 (0.0%) 78.1%


32 13 (40.6%) 15 (46.9%) 3 (9.4%) 1 (3.1%) 0 (0.0%) 87.5%



Strongly Agree


N/A


12*^ 1

(8.3%) 4

(33.3%) 6

(50.0%) 1

(8.3%) 0

(0.0%) 20 41.7%

Bold/ Shaded = the majority of subjects responded favorably, >50% *Only subjects included in the Actinic Keratosis group (n=14) were included in the analysis. ^1 subject (#2) responded with an NA for question 13 and subject #33 did not attend the Week 4 visit (12 subjects analyzed).


CONFIDENTIAL 27


Question n

Week 8 Percent




Strongly Disagree


33 8 (24.2%) 11 (33.3%) 12 (36.4%) 2 (6.1%) 0 (0.0%) 57.6%


33 4 (12.1%) 15 (45.5%) 11 (33.3%) 3 (9.1%) 0 (0.0%) 57.6%


33 9 (27.3%) 17 (51.5%) 5 (15.2%) 2 (6.1%) 0 (0.0%) 78.8%


33 5 (15.2%) 17 (51.5%) 10 (30.3%) 1 (3.0%) 0 (0.0%) 66.7%


33 6 (18.2%) 12 (36.4%) 14 (42.4%) 1 (3.0%) 0 (0.0%) 54.5%


33 8 (24.2%) 17 (51.5%) 7 (21.2%) 1 (3.0%) 0 (0.0%) 75.8%


33 6 (18.2%) 12 (36.4%) 13 (39.4%) 2 (6.1%) 0 (0.0%) 54.5%


33 6 (18.2%) 10 (30.3%) 15 (45.5%) 2 (6.1%) 0 (0.0%) 48.5%


33 9 (27.3%) 18 (54.5%) 5 (15.2%) 1 (3.0%) 0 (0.0%) 81.8%


33 7 (21.2%) 17 (51.5%) 8 (24.2%) 1 (3.0%) 0 (0.0%) 72.7%


33 7 (21.2%) 18 (54.5%) 7 (21.2%) 1 (3.0%) 0 (0.0%) 75.8%


33 21 (63.6%) 9 (27.3%) 3 (9.1%) 0 (0.0%) 0 (0.0%) 90.9%



Strongly Agree


N/A


13*^ 2

(15.4%) 4

(30.8%) 6

(46.2%) 1

(7.7%) 0

(0.0%) 20 46.2%

Bold/ Shaded = the majority of subjects responded favorably, >50% *Only subjects included in the Actinic Keratosis group (n=14) were included in the analysis. ^1 subject (#2) responded with an NA for question 13 (13 subjects analyzed).


CONFIDENTIAL 28

19.2 Discussion

19.2.1 Enrollment and Demographics

At least 30 female subjects, ages 35 and 59 years old, were required to complete study participation. The study completed with 33 female subjects with an age range of 35 to 60 with an average age of 51.51 years old. The population’s ethnicity was 81.8% Non-Hispanic or Latino and 18.2% Hispanic or Latino. The population’s reported race was 81.8% White, 15.2% No Response (Hispanic or Latino) and 3.0% African American or Black.

19.2.2 Expert Visual Grading

Catalyst AC-11:

Analysis of results revealed statistically significant improvement from Baseline in mean scores for the appearance of facial skin’s texture/smoothness (visual), fine lines/wrinkles-crow’s feet, radiance / luminosity, eyelid laxity, elasticity (tactile), overall appearance, capillary visibility and actinic keratosis severity immediately after use.

Of particular note, immediate improvement in the appearance of fine lines/wrinkles – crow’s feet was seen in 100 percent of subjects and more than 90 percent showed immediate improvement in the appearance of skin texture/smoothness (visual), radiance/luminosity and elasticity (tactile).

Regimen:

Analysis of results revealed statistically significant improvement from Baseline in mean scores for the appearance of facial skin’s texture/smoothness (visual), fine lines/wrinkles-crow’s feet, radiance / luminosity, eyelid laxity, elasticity (tactile), overall appearance, capillary visibility and actinic keratosis severity after 8 weeks of use. Further statistically significant improvement from Baseline was observed in mean score for overall appearance at Weeks 1 and 4, and for radiance / luminosity, eyelid laxity and capillary visibility at Week 4.

Further, 100 percent of subjects showed improvement from Baseline to Week 8 in results for the appearance of radiance/luminosity and overall appearance, and more than 90 percent showed improvement from Baseline to Week 8 in results for the appearance of actinic keratosis severity.

Statistically significant worsening from Baseline was observed in mean score for the appearance of facial skin’s fine lines/wrinkles-crow’s feet at the Week 1 visit.


CONFIDENTIAL 29

19.2.3 Instrumental Assessments

Catalyst AC-11:

Cutometer: No Statistically significant improvements from Baseline were observed in mean Cutometer results for skin firmness or skin elasticity immediately following product application.

Regimen:

Cutometer: Statistically significant improvements from Baseline were observed in mean Cutometer results for skin firmness at the Week 8 visit and for skin elasticity at the Week 4 and Week 8 visits.

Statistically significant improvement from Baseline was observed in SIAscope results for skin hemoglobin at the Week 4 and 8 visits. Alternately, statistically significant worsening from Baseline was observed in SIAscope results for hemoglobin at Week 1.

19.2.4 Subjective Questionnaire

Catalyst AC-11:

The majority of subjects (>50%) responded favorably (“agree” or “strongly agree”) to the statements “The product immediately improved the firmness of my facial skin”, “The product immediately improved the elasticity of my facial skin”, “The product immediately tightened my facial skin”, “My facial skin appears less dull and more radiant immediately after using the product” and “I did not experience any irritation after product application”.

Regimen:

At Weeks 1, 4 and 8 the majority of subjects responded favorably to questions regarding improvement in the appearance of facial skin’s firmness, elasticity, tightness, radiance, youthful complexion and its overall appearance. The majority also indicated that they did not experience any irritation.

Further, at Week 8, the majority of subjects responded favorably to questions regarding improvement in the appearance of capillary redness, eyelid laxity, facial sagging and lines/wrinkles – crow’s feet area.

20.0 Conclusion

In conclusion, under the conditions of this study, use of Catalyst AC–11 #OS-PRD-CAC-030 alone and of a regimen consisting of Purify #OS-PRD-PUR-200; Catalyst AC–11 #OS-PRD-CAC-030; Spritz Clear Plus #OS-PRD-CLR-100; Quench Plus #OS-PRD-QUE-031 led to significant improvements in skin appearance and condition as evidenced by results from expert clinical grading, instrumental assessments and subjective questionnaire results.

Catalyst AC–11 #OS-PRD-CAC-030: Expert clinical grading revealed immediate, statistically significant improvements in the appearance of facial skin’s texture/smoothness (visual), fine lines/wrinkles-crow’s feet, radiance / luminosity, eyelid laxity, elasticity (tactile), overall appearance, capillary visibility and actinic keratosis severity. Subjective questionnaire results revealed that the majority of subjects


CONFIDENTIAL 30

believed that its use resulted in immediate improvements in the appearance of facial skin’s firmness, elasticity, tightness and radiance, and that the product did not cause them any skin irritation.

Test Product Regimen: Purify #OS-PRD-PUR-200; Catalyst AC–11 #OS-PRD-CAC-030; Spritz Clear Plus #OS-PRD-CLR-100; Quench Plus #OS-PRD-QUE-031: Statistically significant improvements were observed in expert clinical grading results for overall (facial) appearance after one and four weeks of use, for radiance / luminosity, eyelid laxity and capillary visibility after four weeks of use and for texture/smoothness (visual), fine lines/wrinkles-crow’s feet, radiance / luminosity, eyelid laxity, elasticity (tactile), overall appearance, capillary visibility and actinic keratosis severity after eight weeks of use.

Instrumentally, improvement in skin’s elasticity was observed after four weeks of use, and improvements in both firmness and elasticity were observed after repeated applications for eight weeks.

Subjective questionnaire results revealed that the majority of subjects believed that its use resulted in improvements in the appearance of facial skin’s firmness, elasticity, tightness and radiance, and that the product did not cause them any skin irritation after one, four and eight weeks of use, and also resulted in improvements in the appearance of facial skin’s capillary redness, eyelid laxity, facial sagging and lines/wrinkles – crow’s feet area after eight weeks of use.


CONFIDENTIAL Appendix I

Appendix I

Protocol

IRSI, Inc. Protocol No. 3931OSM0415 Final Protocol Ver. 2.6 June 29, 2015

CONFIDENTIAL 2

Study Summary

Title An eight-week clinical study to evaluate the efficacy of a regimen of topical products on skin condition

Protocol Number 3931OSM0415

Sponsor Osmosis, LLC

Methodology Monadic

Objective To evaluate the efficacy of one product to improve skin appearance and condition

Number of Subjects 30 to complete, target enrollment 35

Target Population Female subjects, age 35-59 years old

Duration 8 Weeks + 1 week washout (Screening/Washout (T-7D), Baseline, Week 1, Week 4, Week 8)

Claims

Claims to be assessed immediately after application of the Catalyst AC-11 product and after prolonged use of the topical product regimen

Claim Support

Reduces capillary redness and capillary visibility

Expert Clinical Grading SIAScope Subjective Questionnaires Photo Documentation (n=5)

Improves skin elasticity and firmness

Expert Clinical Grading (elasticity only) Subjective Questionnaires Cutometer

Improves eyelid laxity Expert Clinical Grading Subjective Questionnaires Photo Documentation (n=5)

Improves the appearance of lines/wrinkles

Improves skins overall appearance, radiance and luminosity

Study Products

Name Formula Number

Purify OS-PRD-PUR-200

Catalyst AC - 11 OS-PRD-CAC-030

Spritz Clear Plus OS-PRD-CLR-100

Quench Plus OS-PRD-QUE-031

Supportive Products Dove Beauty Bar, White Purpose Dual Treatment Moisture Lotion with SPF 15

NA NA

Statistical Methodology

Descriptive statistics reported for demographics, instrumental and visual assessments. Monadic data analyses will use paired t-test to determine significance of change from Baseline. Questionnaire response frequencies and mean indicated percent improvement reported for each question. All final statistical analyses will be performed on the PP population, significance set at p≤0.05.

Study Schedule Initiation: Consent / Washout June 8, 2015

Baseline June 15, 2015




Intermediate Topline: Week 4 July 27, 2015

Final Topline: Week 8 August 24, 2015

Photographs: September 15, 2015

Draft Final Report: September 15, 2015

*Delivery dates subject to change ± 2 business days


CONFIDENTIAL 3

Table of Contents

1.0 Introduction ...................................................................................................................................... 5

2.0 Objectives.......................................................................................................................................... 5

3.0 Study Design...................................................................................................................................... 5

4.0 Products ............................................................................................................................................ 6

5.0 Population ......................................................................................................................................... 8

6.0 Methods ............................................................................................................................................ 9

7.0 Procedure ........................................................................................................................................ 13

8.0 Concomitant Medications and Products ........................................................................................ 15

9.0 Adverse Events ................................................................................................................................ 16

10.0 Institutional Review Board .............................................................................................................. 17

11.0 Informed Consent ........................................................................................................................... 17

12.0 Discontinuation of Study ................................................................................................................. 17

13.0 Changes to the Protocol .................................................................................................................. 17

14.0 Monitoring ...................................................................................................................................... 18

15.0 Recording of Data ........................................................................................................................... 18

16.0 Quality Control and Quality Assurance ........................................................................................... 18

17.0 Ethics ............................................................................................................................................... 19

18.0 Statistical Methods ......................................................................................................................... 19

19.0 Reporting of Results ........................................................................................................................ 19

20.0 Record Retention ............................................................................................................................ 20

21.0 Publication Policy ............................................................................................................................ 20

22.0 References ...................................................................................................................................... 20

Appendices Appendix I Product Use Instructions and Diary

Appendix II Subjective Questionnaire

Appendix III Case Report Forms Appendix IV Informed Consent Form and Model Release Form Appendix V Randomization Code(s)


CONFIDENTIAL 4

List of Abbreviations

AE BL C cm CRF CFR D FDA GCP HIPAA ICF ICH IND IRB IRSI AIDS n NDA PI PP SAE SOP Sponsor T15m US VAS W1 W4 W8 X

Adverse Event Baseline Collect Centimeter Case Report Form Code of Federal Regulations Dispense Food & Drug Administration Good Clinical Practices Health Insurance Portability and Accountability Act Informed Consent Form International Conference on Harmonization Investigational New Drug Institutional Review Board International Research Services, Inc. Acquired Immunodeficiency Syndrome Number of Subjects New Drug Application Principal Investigator Per-Protocol Serious Adverse Event Standard Operating Procedure Osmosis, LLC Immediate, approximately 15 minutes post-application United States Visual Analogue Scale Week 1 Week 4 Week 8 Times


CONFIDENTIAL 5

1.0 Introduction

This document is a protocol for a human research study. This study will be conducted according to International Research Services, Inc. research policies and Standard Operating Procedures, U.S. and international standards of Good Clinical Practice (FDA and ICH guidelines) and applicable government regulations.

1.1 Background

The face holds an integral role in human social communication and how humans are perceived as attractive. In addition to structural facial features, studies have shown that skin appearance is highly weighed in the perception of beauty and is determined primarily by its coloration and surface topography.1 Aging is caused by two processes, intrinsic and extrinsic. The sun is the primary cause of extrinsic aging and has also been shown to alter the normal course of intrinsic or natural aging.2 Current treatments for photoaged skin are offered in a variety of methods including non-invasive and invasive medical procedures, chemical peels, topical prescription and cosmetic products, most of which are intended to resurface the epidermis.3 As the need for efficacious treatments available to the consumer is evident, this study intends to investigate the effects of a product intended to improve the appearance and condition of facial skin.

Osmosis, LLC (Sponsor) has contracted with IRSI to develop and perform a clinical protocol designed to test the effects of a product regimen on facial skin in a population of female subjects, all of whom have photodamaged skin.

2.0 Objectives

2.1 Primary Objective

This study will determine the efficacy of a topical product regimen including four products intended to improve facial skin appearance and condition.

2.2 Secondary Objective

This study will determine the immediate efficacy of one topical product intended to improve facial skin appearance and condition.

3.0 Study Design

This is an eight-week monadic clinical study to evaluate the efficacy of an individual product for immediate results and a topical product regimen for eight weeks. Data will be analyzed for signs of improvement in facial skin condition and appearance in female subjects who have photodamaged skin. Assessments will include expert clinical visual grading, instrumental assessments and photographic documentation. Subjects’ perception of product effects will be captured via subjective questionnaire. The treatment products will be used daily per Sponsor instructions by all subjects for eight weeks. At least 30 subjects are expected to complete study participation. The study will be preceded by a one-week washout period, within which subjects will discontinue use of all facial cleansers and moisturizers and use only support product on their faces, as directed by IRSI.

Study visits will occur at Screening/ Washout (T-7D), Baseline (BL), Immediate (T15m) and at Weeks 1, 4 and 8 (W1, W4 and W8). A detailed outline of study visits appears in Section 7.0.


CONFIDENTIAL 6

3.1 Claims:

Assessment and questionnaire data will be analyzed with particular regard to the following desired key product effects for the regimen of four products after prolonged use:

1. Reduces capillary redness and capillary visibility, as determined by expert clinical grading, SIAScope, subjective questionnaires and photo documentation.

2. Improves elasticity and firmness, as determined by expert clinical grading (elasticity only), Cutometer and subjective questionnaires.

3. Improves eyelid laxity, as determined by expert clinical grading, subjective questionnaires and photo documentation.

4. Improves the appearance of lines/wrinkles, as determined by expert clinical grading, subjective questionnaires and photo documentation.

5. Improves skins overall appearance, radiance and luminosity, as determined by expert clinical grading, subjective questionnaires and photo documentation.

3.2 Claims (Catalyst AC-11)

Assessment and questionnaire data will be analyzed with particular regard to the following desired key product effects for the Catalyst AC-11 cream after a single application:

1. Immediately reduces capillary redness and capillary visibility, as determined by expert clinical grading, subjective questionnaires and photo documentation.

2. Immediately improves eyelid laxity, as determined by expert clinical grading, subjective questionnaires and photo documentation.

3. Immediately improves elasticity and firmness, as determined by expert clinical grading (elasticity only), Cutometer and subjective questionnaires (elasticity only).

4. Immediately improves the appearance of lines/wrinkles, as determined by expert clinical grading, subjective questionnaires and photo documentation.

5. Immediately improves skins overall appearance, radiance and luminosity, as determined by expert clinical grading, subjective questionnaires and photo documentation.

4.0 Products

The test products will be provided by the Sponsor and will bear appropriate coding labels and proper use instructions. Supportive product(s) will be provided by IRSI. Study products will be stored in a secure location and unused test product will be returned to Sponsor or discarded upon issue of final report in accordance with IRSI’s SOP.


CONFIDENTIAL 7

4.1 Product Descriptions

Name Designation Formula Number

Study Product

Purify Cleanser OS-PRD-PUR-200

Catalyst AC-11 Gel OS-PRD-CAC-030

Spritz Clear Plus Enhancer OS-PRD-CLR-100

Quench Plus Moisturizer OS-PRD-QUE-031

Supportive Products

Dove Beauty Bar, White Washout Cleanser NA

Purpose Dual Treatment Moisture Lotion with SPF 15 SPF Moisturizer NA

4.2 Product Use Instructions

Subjects will be provided with Support Washout Cleanser and SPF Moisturizer approximately seven days before Baseline.

At Baseline, subjects will discontinue the use of the Support Washout Cleanser and SPF Moisturizer and will be provided with the test product regimen to use for the duration of the study.

At the Baseline visit, all subjects will apply the Catalyst AC-11 product only to the face following Sponsor instructions under IRSI technician supervision.

Sponsor-provided use instructions will be explained to subjects and will be provided to each subject in their printed Study Instructions (See Appendix I).

Test Product Directions:

Use the test products twice daily, morning and evening in the following sequence:

Step 1: Wash face with Purify:

Apply ½ pump into palm of hand and lather face and neck with warm water, thoroughly Cleanse and rinse until all product has been removed. Dry skin with a soft towel.

Step 2: Apply Catalyst AC-11

Apply two pumps into hand and massage onto face and neck thoroughly. Massage into skin thoroughly.

Step 3: Spritz Clear Plus:

Spray Clear Plus 3-5 times onto face and neck and massage skin again until all product is absorbed into skin. This step is essential to ensure Catalyst AC-11 is fully absorbed.

Step 4: Quench Plus:

Apply 1-2 pumps Quench Plus into hand and massage onto entire face and neck.


CONFIDENTIAL 8

Support Product Directions:

Washout Period (T-7d):

Washout Cleanser: Use daily in place of your normal facial cleanser.

SPF Moisturizer: Apply daily in the morning prior to sun exposure, reapply every 2 hours as needed throughout the day during sun exposure during the washout period.

Study Period: Per sponsor, no sunscreen is permitted for use during study period.

Avoid sun exposure to the face, no sunscreen use is permitted, use hats and/or umbrellas when going into sun.

5.0 Population

5.1 Sample Size

The sample size of n=30 was requested by the Sponsor. A sufficient number of subjects will be enrolled in order to complete this study with no less than 30 subjects. The target enrollment is 35 subjects.

5.2 Inclusion Criteria


2. Subjects with lines and wrinkles and eyelid laxity as determined by an expert grader at Baseline.

a. Score of ≥2 cm on 10 cm VAS for fine lines/wrinkles (crow’s feet) b. Score of ≥2 cm on 10 cm VAS for eyelid laxity

3. A portion of the panel (approximately n=10) with Capillary visibility (telangiectasia) a. Score of ≥2 cm on 10 cm VAS for capillary visibility

4. A portion of the panel (approximately n=10) with actinic keratosis as determined by an expert grader at baseline.

a. Score of ≥2 cm on 10 cm VAS for actinic keratosis severity 5. Willing to be photographed and sign a photograph release form. 6. Able to read, understand and willing to sign an ICF, including HIPAA and state requirements,


requirements, including but not limited to: a. Willing to abstain from any other superficial or deep facial procedure during the

study (dermabrasion, microdermabrasion, peels, photo facials, laser treatment, facial lesion removal, etc.).



5.3 Exclusion Criteria




CONFIDENTIAL 9

2. Subjects with present or previous inflammatory or other skin diseases, such as rosacea,

severe acne, Systemic Lupus Erythematosus (SLE), dermatomyositis, scleroderma, etc.




5. Subjects having an acute or chronic disease or medical condition, including dermatological

problems, which could put her at risk in the opinion of the Principal Investigator or

compromise study outcomes. Typical uncontrolled chronic or serious diseases and

conditions which would prevent participation in any clinical trial are cancer, AIDS, diabetes,

morbid obesity, renal impairment, mental illness, drug/alcohol addiction.


7. History of allergic reactions, skin sensitization and/or known allergies to cosmetic

ingredients, toiletries, sunscreens, etc.


9. Woman who started Hormone Replacement Therapy within the last three months preceding

the screening visit

10. Woman using oral contraception for less than three months before the screening visit or who

has changed her contraceptive method within the three months before the Baseline visit or

planning to modify her contraception treatment within the duration of the study

11. Woman known to be pregnant, lactating or planning to become pregnant within six months.

Subjects who become pregnant during the study must inform the Principal Investigator

immediately

12. Individuals unable to communicate or cooperate with the Principal Investigator due to

language problems, poor mental development, or impaired cerebral function

13. Employees of IRSI or other testing firms/ laboratories, cosmetic or raw goods manufacturers

or suppliers

6.0 Methods

6.1 Expert Grading Assessments for Efficacy

Visual Analog Scales (VAS) are commonly used in clinical research to measure intensity or frequency of various symptoms, subjective characteristics or attitudes that cannot be directly measured. VAS are a reliable scale and more sensitive to small changes than simple ordinal scales.4 When responding to a VAS item, the expert grader specifies their level of agreement to a statement by indicating a position along a line (10 cm) between two end-points or anchor responses. Simple VAS will be used to evaluate efficacy parameters in which the ends of a 10 cm horizontal line will be defined as extreme limits orientated from the left (best) to the right (worst).

All subjects will have facial skin texture /smoothness (visual), lines/wrinkles (crow’s feet), elasticity (tactile), eyelid laxity, radiance/luminosity, and overall appearance assessed by an expert grader at BL, T15m, W1, W4 and W8. A portion of the panel which presents with capillary visibility and Actinic Keratosis at Baseline will be assessed by an expert grader for these attributes at BL, T15m, W1, W4 and W8.


CONFIDENTIAL 10

The same expert grader will assess the same subjects at every time point. Clinical grading will be performed in the same room at each study visit using overhead lighting as well as a lighted magnifying loop as needed. Natural sunlight will be blocked from the room to ensure the same lighting conditions at each time point.

The following IRSI-developed VAS will be used:

Texture / Smoothness - Visual

0 cm 10 cm Smooth, even

surface appearance

Rough, uneven surface

appearance


0 cm 10 cm

None

Numerous lines/ Wrinkles –

Severe, Deep

Radiance / Luminosity

0 cm 10 cm Radiant,

Luminous appearance

Dull/Matte

and/or Sallow

Eyelid Laxity

0 cm 10 cm Taut,

“awake”, smooth eyelid

Sagging, “tired”,

drooping eyelid


0 cm 10 cm Good

Stretch and Bounce back

Poor Stretch and Bounce

back


CONFIDENTIAL 11

Overall Appearance

0 cm 10 cm Vibrant, Healthy

appearance

Aged, Unhealthy

appearance


0 cm 10 cm

None *Only grade if subject presents this at Baseline (portion of panel)

Highly visible,



0 cm 10 cm

None *Only grade if subject presents this at Baseline (portion of panel) Highly visible

patches

6.2 Instrumental Evaluations

Test environment temperature (°F) and humidity (%) will be recorded in every room used for study conduct every hour. Additionally, once-daily outdoor conditions will be recorded for each visit.

6.2.1 COSMETRICS™ SIAscope

The COSMETRICS™ SIAScope (Astron Clinica, Toft, UK) is a non-invasive optical skin imaging instrument using Spectrophotometric Intracutaneous Analysis (SIA), or chromophore mapping. The technique is based on a unique combination of dermatoscopy and contact remittance spectrophotometry. The hardware consists of a hand-held imaging probe attached to a laptop computer. The unit is placed in contact with the skin surface and high-intensity LED’s illuminate the skin as discreet wavelengths of 400 to 1000nm, spanning the visible spectrum and a small range of the near infrared spectrum. A digital image is captured for each wavelength.

Three parametric chromophore maps are retrieved up to 2 mm in depth and 11 mm in circumference, one for each of the following parameters: epidermal melanin, dermal hemoglobin and dermal collagen.

For this study, dermal hemoglobin measurements will be taken in duplicate and averaged on a spot determined at Baseline with visible red capillaries if applicable or on the cheek if no capillaries visible, at BL, W1, W4 and W8. The same location will be measured at each time point and recorded using a face map.


CONFIDENTIAL 12

6.2.2 CUTOMETER

The Cutometer MPA 580 (Courage + Khazaka, Germany) measures the viscoelastic properties of the skin by applying suction to the skin surface, drawing the skin into the aperture of the probe and determining the penetration depth using an optical measuring system.

The resistance of the skin to be sucked up by the negative pressure (firmness) and its ability to return to its original position (elasticity) are calculated and displayed as curves. The Cutometer outputs include many parameters of different portions of the measurement curve including of R0 (Uf, firmness), R2 (Ua/Uf, gross elasticity), R5 (Ur/Ue, net elasticity), R7 (Ur/Uf, elastic portion) and R9 (R3[last max amp]-R0[Uf], fatigue).

Skin Elasticity will be reported using the R5 (Ur/Ue) parameter, as the skin becomes more elastic this value will increase. Skin Firmness will be reported using the R0 (Uf) parameter, as the skin becomes firmer this value will decrease.

All subjects will have Cutometer measurements taken on their left or right cheek, as determined by a randomization code, in duplicate and averaged at BL, T15m, W1, W4 and W8. Assessment location will be recorded on a face map for each subject.

6.3 Photography

All clinical photography is performed in accordance with IRSI’s SOP to ensure reproducibility of high quality images throughout the duration of the study. Imaging is conducted in a designated photography suite with a matte black wall and all natural light is blocked out. To prepare subjects for clinical photography, subjects will be asked to remove all jewelry, including earrings, necklaces and any facial jewelry. A trained technician will inspect the subjects under a lighted magnification loop to ensure no residual color cosmetics or skincare products are visible on the face, eyes or lips. Subjects will be provided with a black cape and black headband and will be instructed on placement to ensure all hair is pulled back neatly and covered.

6.3.1 Clarity™ 2D Research System Ti

The Clarity™ 2D Research System Ti (Clarity) (BrighTex Bio-Photonics (BTBP), San Jose CA, USA) captures high quality full face frontal, left and right lateral images. Three cameras within the system allow for 18 megapixel SLR image capture in 16-bit simultaneously using a live feed display and automated facial alignment checks against baseline images for reproducibility.

A subgroup of five (N=5) subjects chosen at random will have Left, Right and Center facial images captured at BL, W1, W4 and W8. Photographs will be for documentation purposes only.

6.4 Subjective Questionnaire

Subjective questionnaires allow the Sponsor to gauge the subjects’ opinions of the test product and its effects. Questions will ask for subjects’ agreement to a statement with a five point scale, IRSI will provide questionnaire and perform analysis (See Appendix II).


CONFIDENTIAL 13

Subjects will complete the questionnaire at T15m regarding Catalyst AC-11 immediate effects and again at W1, W4 and W8 regarding prolonged use of the four product regimen.

7.0 Procedure

7.1 Consent / Screening Visit / Washout

Potential subjects will come to the clinic approximately seven days prior to the Baseline visit to read and sign an informed consent form (ICF), as described in Section 11, a model release form, inclusion / exclusion criteria and to complete a brief personal/medical history.

Unless a response(s) on their medical history form, inclusion / exclusion criteria or ICF indicate that they are not qualified to participate in the study, each potential subject will receive the support Washout Cleanser and Washout SPF Moisturizer and instructions for its use during the seven-day washout period.

They will then receive an appointment time for their Baseline visit and will be dismissed from the consent / screening / washout visit.

7.2 Baseline Visit

Subjects will arrive at IRSI with clean facial skin, having washed their face and applied no topical treatment or cosmetic products within one hour prior to their visit.

Potential subjects will acclimate to clinic environment with their facial skin exposed for at least 15 minutes allowing subject to relax and let their skin balance to the environment.

Following acclimatization, potential subjects will be screened to determine if they meet study entrance criteria as described in Section 5.2 and 5.3.

The following Screening procedures will be performed and all findings will be reported on the appropriate CRFs:

- Review of compliance to washout, updated Medical History and inclusion / exclusion criteria.

- Expert visual evaluation for any skin condition which would disqualify subject from study enrollment.

- Expert visual evaluation for qualification according to inclusion criteria 4.a and 4.b, above, in section 5.2.

Subjects who meet entrance criteria as defined in Section 5.2 and 5.3 will be enrolled and proceed with study participation.

The following BL assessments will be performed and all findings will be reported on the appropriate CRFs:


All subjects will be provided with the test product regimen along with instructions and diary to record use per section 4.2.

Subjects will apply the Catalyst AC-11 product to their face under supervision as described in Section 4.2.

Approximately 15 minutes post-application the following T15m assessments will begin and all findings will be reported on the appropriate CRFs:

- Expert visual grading as described in Section 6.1 - Instrumental assessments as described in Section 6.2


CONFIDENTIAL 14

- Subjective Questionnaire as described in Section 6.4 Subjects will be advised to inform the laboratory immediately if any adverse reactions are

experienced during the study. After all evaluations are completed, subjects will be given an appointment time for their Week 1

visit and will be dismissed from the Baseline visit.

7.3 Week 1, 4 and Week 8 Visits

Subjects will arrive at IRSI with clean facial skin, having washed their face and applied no topical treatment or cosmetic products within one hour prior to their visit.

Review of compliance to study instructions, updated Medical History Subjects will acclimate to clinic environment with their facial skin exposed for at least 15

minutes allowing subject to relax and let their skin balance to the environment. The following assessments will be performed and all findings will be reported on the appropriate

CRFs: - Expert visual grading as described in Section 6.1 - Instrumental assessments as described in Section 6.2 - Photography as described in Section 6.3 - Subjective Questionnaires as described in Section 6.4

Each subject’s products will be inspected to ensure product use compliance and/or that enough product remains for study duration, and diaries will be reviewed and/or subjects will be queried to detect any changes in subject’s health.

At W1 and W4, subjects will be advised to inform the laboratory immediately if any adverse reactions are experienced during the study.

At W1 and W4, after all evaluations are completed, subjects will be given an appointment time for their next visit and dismissed.

At W8, subjects will be advised to inform the laboratory immediately if any adverse reactions are experienced during the 48 hours following study completion.

At W8, after all evaluations are completed, subjects will return any unused products and/or empty containers and will be given a stipend for their participation and dismissed from the study.


CONFIDENTIAL 15

7.3.1 Procedure Summary Table

Procedures Screening/ Washout Baseline

Immediate Week 1 Week 4 Week 8

Study Initiation and Qualification

Informed Consent and Medical History

X

Inclusion/Exclusion Criteria reviewed

X X

Dispense/ Collect Products D

Support D

Test

C

Expert Clinical Grading

- Texture (visual) -Lines/Wrinkles (Crow’s Feet) - Radiance/ Luminosity -Eyelid Laxity -Elasticity -Overall Appearance -Capillary Visibility - Actinic Keratosis Severity

X X X X X

Instrumental Evaluation

SIAScope (hemoglobin)

X

X X X

Cutometer (elasticity,

firmness) X

X X X X

Photography Clarity 2DResearch Ti (n=5, L, R,C views)

X

X X X

Consumer Perception


X

Catalyst AC-11 only

X X X

8.0 Concomitant Medications and Products

The use of any topical skin treatment products (other than those assigned during the study) on the face will be prohibited during the washout and study periods. This includes, but is not limited to moisturizers, serums, cleansers, sunscreens and medicated creams.

Use of superficial or deep facial procedures during the study is prohibited including dermabrasion, microdermabrasion, peels, photo facials, laser treatments, facial lesion removal.

Major medical procedures should be avoided including endoscopy or any procedure requiring sedation (if medically necessary subject will be discontinued from study participation).

The use of color cosmetics is allowed, no new personal care products should be introduced for the duration of the study.

Smoking is prohibited for the duration of the study.


CONFIDENTIAL 16

9.0 Adverse Events

Subjects will be advised to report all adverse events to the study personnel as soon as possible. An adverse event (AE) is any untoward medical occurrence experienced by a subject whether or not considered product related.

An adverse event must have an onset time after the subject is enrolled in the study and generally within one week after the subject's participation in the study has ended. The endpoint will depend on the nature of the product being tested.

An adverse event may consist of a:

Disease or injury Exacerbation of pre-existing illness or condition Recurrence of an intermittent illness or condition Set of related signs or symptoms Single sign or symptom

Adverse events will be recorded on the appropriate case report form and include the Principal Investigator's assessment of product relationship as follows:

0 = None 1 = Remote 2 = Possible 3 = Probable 4 = Definite

The Principal Investigator's assessment will be summarized in the final report.

9.1 Serious Adverse Events

A serious adverse event will be defined as any experience which is (any one or more of the following):

Fatal Life-threatening Persistent or significant disability/incapacity Required or prolongs inpatient hospitalization Results in congenital anomaly or birth defect

9.2 Reporting of Adverse Events

Adverse events will be documented on the appropriate form and reported to the Sponsor within five business days if any relationship to the product(s) is determined by the PI. The Sponsor will be notified of any serious adverse event (SAE) within 24 hours of recording the experience (when possible). Additionally, all AEs, serious / not serious, related / not related will be summarized in the final report and a copy of the AE form will be appended to the final report. Proper judgment will be exercised in deciding whether expedited reporting is appropriate in other situations, such as events that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the patient or may require intervention to prevent one of


CONFIDENTIAL 17

the other outcomes listed in the definition above. These should also usually be considered serious (FDA 21 CFR., Vol. 62, No. 194, 52243). Examples are:

Overdose Intensive treatment in an emergency room or at home for allergic bronchospasm

Development of drug dependency or drug abuse

Sponsor Contact for Reporting AEs and SAEs Contact: Ben Johnson, MD Address: 30746 Bryant Drive Unit #410

Evergreen, CO 80439 Phone: 303.674.7660 E-Mail: [email protected]

IRSI staff and its Investigators do not assume Sponsor obligations for reporting SAEs to the FDA or other regulatory agencies.

10.0 Institutional Review Board

IRB review was not requested by the Sponsor for this study.

11.0 Informed Consent

The informed consent process will be completed prior to an individual’s involvement in any study related activity. The process will be documented using a written informed consent form (ICF) conforming to FDA 21 CFR 50.25 (See Appendix IV).

The study Principal Investigator or his designee will inform the individual of all aspects of the trial that are relevant to the subject’s decision to participate, and the individual will have the opportunity to have any questions answered. As part of the written consent, the subject will be informed that she has the right to discontinue participation in the study at any point. Subjects who are not capable of providing or are unwilling to provide voluntary informed consent will not be enrolled.

After review, two copies of the ICF will be signed and dated by the individual and the Principal Investigator or his designee administering the consent. One original copy will be retained by IRSI and the other will be given to the individual.

12.0 Discontinuation of Study

The Sponsor, Principal Investigator, and IRSI have the right to discontinue the study for medical, safety or administrative reasons at any time. Appropriate procedures will be followed to ensure the safe withdrawal of each subject from the study.

13.0 Changes to the Protocol

Upon Sponsor, Principal Investigator, Study Coordinator and IRB approval and signing, this study protocol is considered final. Changes to the protocol must be approved in writing by the Sponsor and Principal Investigator prior to implementation. It is the responsibility of the Primary Investigator and Study Coordinator to ensure the protocol is approved and followed in agreement with FDA 21 CFR Part 58 Sec. 58.33.


CONFIDENTIAL 18

Changes to the protocol will be categorized and documented as per IRSI’s SOP as follows: Protocol Amendment, Protocol Deviation: Major and Minor.

13.1 Protocol Amendments

A protocol amendment is any permanent change or written clarification to the study protocol. Amendments may be requested by the Sponsor, Principal Investigator or Study Coordinator.

Amendments to the protocol must be approved in writing by both the Principal Investigator and the Sponsor prior to implementation. The exception shall be when a change is required in the interest of subject protection or safety. In such instances, the sponsor shall be notified in writing within 24-hours of the change, whenever possible.

13.2 Protocol Deviations

A protocol deviation is any divergence or departure from the study protocol or a SOP. Deviations will be categorized by the Study Coordinator as Major or Minor.

A deviation is considered Major when there is a consistent variation in practice from the defined protocol or a subject has been identified as being at risk of harm in relation to their involvement in the study and urgent action, which deviates from the protocol, has occurred. Major deviations will be reported to the Sponsor within 24-hours (when possible) and corrective action (if necessary) will be identified.

A deviation is considered Minor when a variation to the protocol does not affect subject safety or the integrity of the research. Minor deviations will be documented throughout the study and reported to the Sponsor upon completion of the study.

14.0 Monitoring

IRSI will permit trial-related monitoring, audits, IRB review and regulatory inspections at any time. Access to all study documents, source documents and data will be available on site.

15.0 Recording of Data

All data and information, except electronically recorded data (Clarity, SIAScope, Cutometer), will be recorded on specific paper case report forms (CRFs) and this information will be neatly recorded in type or legibly printed in black ink wherever possible (See Appendix III). Any errors will be crossed out and the correct entry made and initialed and dated by the Principal Investigator or his designee, unless the CRF is also a source document completed by the subject (such as a questionnaire) in which case the correction will be made by the subject as described above.

16.0 Quality Control and Quality Assurance

IRSI will audit the study for accuracy, consistency and proper documentation in accordance to IRSI SOPs and practices. The auditor will verify the accuracy of results reported in the data listings and statistical analysis after each study visit. The data listings and database used for statistical analysis will be verified against the CRFs. The data listings will be verified against the CRFs for 100% of the data, in a randomly selected set of the subjects (25% of the total number of subjects). The statistical report(s) will be validated for accuracy and completeness, as well as verifying the correctness of all subject numbers (n) and the analyses performed according to the Statistical Analysis Plan as described in Section 18. The statistical topline tables will be reviewed and compared with the statistical report for accuracy.


CONFIDENTIAL 19

17.0 Ethics

The study will be conducted in accordance with FDA GCP regulations and ICH guidelines in as much as they apply to cosmetic research with the following noted: This is not an IND / NDA clinical trial. IRSI does not assume any Sponsor obligations as stipulated in FDA GCP and ICH documents. This study is not intended for submission to the FDA.

18.0 Statistical Methods

The planned statistical analysis is outlined below for each type of data to be acquired.

The per-protocol (PP) population is defined as the subset of subjects that who complied with the protocol sufficiently to ensure that their data will be likely to exhibit the effects of the treatment. To be considered a PP subject, a subject cannot miss more than one study visit (excluding Baseline or Week 8) or be found to be non-compliant with the study protocol at the discretion of the Principal Investigator (PI).

The PP population will be used for statistical analysis at each time point. Statistical significance is set at p≤0.05.

Data Type Statistical Method Data Reported

Demographics Descriptive Statistics Mean and standard deviation Min and Max Frequency (number and percent)

Clinical Grading for Efficacy, Instrumental Evaluation

Descriptive Statistics Paired T-test (monadic),

Mean and standard deviation Mean percent improvement from Baseline Percent of subjects improving P-value vs. Baseline

Subjective Questionnaire Descriptive Statistics

Frequency tables (n and %) of each response Percent of subjects responding favorably.

19.0 Reporting of Results

A top line report (data only) will be issued electronically approximately ten business days after study completion as indicated below.

Clinical study photographs will be will be saved in .jpeg format and provided to the Sponsor on disc (or USB) approximately five weeks after study completion.

The final draft report will be issued electronically approximately five weeks after study completion. Upon Sponsor approval of the draft, the report will be finalized. If no request for revisions or approval is received from the Sponsor within six weeks after the issuance of the draft report, it will be considered final. Once finalized, the report will be issued on electronic media (USB flash drive or equivalent) via US Mail, additionally an electronic copy will be sent via email.

No data issued prior to the final signed report should be considered as final, further, the Sponsor agrees:

Not to make published claims based on this study prior to its completion and the rendering of a final report.

Not to misrepresent the results of the study.


CONFIDENTIAL 20

Schedule Date

Initiation: Consent / Washout June 8, 2015

Baseline, Immediate June 15, 2015




Deliverable Date of Expected Delivery*

Intermediate Topline (Week 4) July 27, 2015

Final Topline (Week 8) August 24, 2015

Photographs September 15, 2015

Draft Final Report September 15, 2015

*Delivery dates subject to change ± 2 business days

20.0 Record Retention

IRSI shall assume the Principal Investigator responsibilities of maintaining study records for a period of 2 years following the date a marketing application is approved for the test material(s) for the indication for which it is being tested; or, if no application is to be filed or if the application is not approved for such indication, until two years after the investigation is discontinued and FDA is notified, if required. Therefore for this study IRSI will archive the study records for a period of two years after the test is discontinued. Material may be archived in electronic or hard copy form. IRSI does not assume any Sponsor obligation regarding record retention or notification/submission to FDA. Prior to study initiation the Sponsor shall provide written notification to IRSI of any submissions to or approvals sought from FDA for the test materials being studied.

21.0 Publication Policy

Neither the complete nor any part of the results of the study carried out under this protocol, nor any of the information provided by the Sponsor for the purposes of performing the study, will be published or passed on to any third party without the consent of the Sponsor. Conversely, prior to publication or other public presentation of the results from this clinical study, the Sponsor should obtain consent from the Primary Investigator.

22.0 References 1 Samson, B. Fink and P. J. Matts, "Visible skin condition and perception of human facial appearance,"

International Journal of Cosmetic Science, vol. 32, pp. 167-184, 2010. 2 L. Baumann, "Skin aging and its treatment," Journal of Pathology, vol. 211, pp. 241-251, 2007. 3 M. H. Gold, J. Y. Hu, J. A. Biron, M. Yatskayer, A. Dahl and C. Oresajo, "Tolerability and efficacy of

retinoic acid given after full-face peel treatment in photodamaged skin," Journal of Clinical and Aesthetic Dermatiology, vol. 4, no. 101, pp. 40-48, 2011.

4 A. Paul-Dauphin, F. Guillemin, J. Virion and S. Briancon, "Bias and precision in visual analog scales: A randomized controlled trial," American Journal of Epidemiology, vol. 150, no. 10, pp. 1117-27, 1999.


CONFIDENTIAL Appendix I

Appendix I

Product Use Instructions and Diary

Washout Instructions

Screening / Washout

Study Number 3931OSM0415

SUPPORT PRODUCTS USE INTRUCTIONS:

Facial Cleanser: Use Dove Beauty Bar, White in place of your normal facial cleanser

Facial SPF Moisturizer: Apply Purpose Dual Treatment Moisture Lotion with SPF 15 daily in the

morning prior to sun exposure, reapply every two hours as needed throughout the day during sun

exposure

STUDY RESTRICTIONS: DO NOT use any topical skin treatment products (other than those assigned during the study) on the face. This includes, but is not limited to moisturizers, serums, cleansers and medical creams. DO NOT use superficial or deep facial procedures during the study, including dermabrasion, microdermabrasion, peels, photo facials, laser treatments and facial lesion removal.

DO NOT undergo major medical procedures, including endoscopy or any procedure requiring sedation (if medically necessary, then subject will be discontinued from the study) DO NOT introduce new personal care products for the duration of the study

DO NOT smoke for the duration of the study You CAN use color-cosmetics which you were regularly using at the time of study enrollment during the study period.

Return to IRSI on Monday, June 15th at your scheduled time. A few important reminders for your next visit: Please make sure you have cleansed your facial and forearm skin, having washed your face and forearms and applied no topical treatment or cosmetic products, including the test products within one hour prior to your visit.

You will qualify ONLY if your skin shows signs of aging.

Remaining Visit Dates: Monday, June 15th Monday June 22nd Monday, July 13th

Monday, August 10th

If you have any questions, or are experiencing any problems with the provided products, then please call the coordinators at: Robigaile – (914) 937-6500 Ext. 132 or Reception – (914) 937 – 6500 Ext. 111

Thank you for your cooperation!

DIARY AND USAGE INSTRUCTIONS BASELINE THROUGH WEEK 8

Study Number: 3931OSM0415

Subject Initials:

Subject Number:

SUNDAY MONDAY TUESDAY WEDNESDAY THURSDAY FRIDAY SATURDAY

JUNE 15 BASELINE CLINIC VISIT

Product Used

____:___ pm

JUNE 16 Product Used

____:___am ____:___ pm


____:___am ____:___ pm


____:___am ____:___ pm


____:___am ____:___ pm


____:___am ____:___ pm


____:___am ____:___ pm


____:___am ____:___ pm


____:___am ____:___ pm


____:___am ____:___ pm


____:___am ____:___ pm


____:___am ____:___ pm


____:___am ____:___ pm


____:___am ____:___ pm


____:___am ____:___ pm


____:___am ____:___ pm

JULY 1 Product Used

____:___am ____:___ pm

JULY 2 Product Used

____:___am ____:___ pm

JULY 3 Product Used

____:___am ____:___ pm

JULY 4 Product Used

____:___am ____:___ pm

JULY 5 Product Used

____:___am ____:___ pm

JULY 6 Product Used

____:___am ____:___ pm

JULY 7 Product Used

____:___am ____:___ pm

JULY 8 Product Used

____:___am ____:___ pm

JULY 9 Product Used

____:___am ____:___ pm

JULY 10 Product Used

____:___am ____:___ pm


____:___am ____:___ pm


____:___am ____:___ pm

JULY 13 WEEK 4 CLINIC VISIT

WASH FACE

WITHIN ONE HOUR OF APPOINTMENT

DIARY AND USAGE INSTRUCTIONS WEEK 4 THROUGH WEEK 8


Subject Initials:

Subject Number:

PRODUCT USE INSTRUCTIONS CONTINUED ON BACK OF DIARY

SUNDAY MONDAY TUESDAY WEDNESDAY THURSDAY FRIDAY SATURDAY

JULY 13 WEEK 4 CLINIC VISIT

Product Used

___:___am ____:___ pm


____:___am ____:___ pm


____:___am ____:___ pm


____:___am ____:___ pm


____:___am ____:___ pm


____:___am ____:___ pm


____:___am ____:___ pm


____:___am ____:___ pm


____:___am ____:___ pm


____:___am ____:___ pm


____:___am ____:___ pm


____:___am ____:___ pm


____:___am ____:___ pm


____:___am ____:___ pm


____:___am ____:___ pm


____:___am ____:___ pm


____:___am ____:___ pm


____:___am ____:___ pm


____:___am ____:___ pm

AUGUST 1 Product Used

____:___am ____:___ pm


____:___am ____:___ pm


____:___am ____:___ pm


____:___am ____:___ pm

AGUUST 5 Product Used

____:___am ____:___ pm


____:___am ____:___ pm


____:___am ____:___ pm


____:___am ____:___ pm


____:___am ____:___ pm

AUGUST 10 WEEK 8 CLINIC VISIT

WASH FACE

WITHIN ONE HOUR OF APPOINTMENT

DIARY AND USAGE INSTRUCTIONS


Subject Initials:

Subject Number:

Test Product Directions: Apply as directed - see attached sponsor provided instructions

Reminders for your next visit: Bring product and diary

Wash your face within the hour before your appointment

Do not wear any cosmetics or product to any of your visits (including test products)

Reminders for the study: DO NOT use any topical cleansers and skin treatment products (other than those assigned during the study) on your face. This includes, but is not limited to moisturizers, serums, cleansers and medicated creams. DO NOT introduce new cosmetics and personal care products for the duration of the study. Color cosmetics which you are using regularly at the time of study enrollment is allowed. Call IRSI immediately if you experience any signs of irritation or with any questions or concerns.

Robigaile, Study Coordinator: 914-937-6500 ext 132

Reception Desk (during visits): 914-937-6500 ext 111

THANK YOU FOR YOUR PARTICIPATION


CONFIDENTIAL Appendix II

Appendix II


CASE REPORT FORM

Subjective Questionnaire Immediate (T15m)

June 15, 2015


Subject Initials

Subject Number

Do not write below this line, for IRSI staff use only.

This CRF has been reviewed for completion prior to subject’s dismissal from station Tech Initials: IMMEDIATE:

Page 1 of 4 This CRF has been reviewed for completion prior to subject’s dismissal from study visit

Tech Initials:

Please rate the level of agreement to the statements 15 minutes after product (Catalyst AC-11 only) application using the rating scales provided below. Be sure to answer every question. 1. The product immediately reduced the capillary redness of my facial skin.

a. Strongly Agree

b. Agree

c. Neutral

d. Disagree

e. Strongly Disagree

2. The product immediately improved the laxity (droopiness) of my eyelid skin. a. Strongly Agree

b. Agree

c. Neutral

d. Disagree


3. The product immediately improved the firmness of my facial skin. a. Strongly Agree

b. Agree

c. Neutral

d. Disagree


Questionnaire continued on the next page

CASE REPORT FORM


June 15, 2015


Subject Initials

Subject Number




Tech Initials:

4. The product immediately improved the elasticity of my facial skin. a. Strongly Agree

b. Agree

c. Neutral

d. Disagree


5. The product immediately lifted my facial skin and improved the appearance of sagging in my face a. Strongly Agree

b. Agree

c. Neutral

d. Disagree


6. The product immediately tightened my facial skin a. Strongly Agree

b. Agree

c. Neutral

d. Disagree


7. The product immediately improved the appearance of lines/wrinkles on my crow’s feet area. a. Strongly Agree

b. Agree

c. Neutral

d. Disagree



CASE REPORT FORM


June 15, 2015


Subject Initials

Subject Number




Tech Initials:

8. The product immediately reduced the appearance of lines/wrinkles on my facial skin.

a. Strongly Agree

b. Agree

c. Neutral

d. Disagree


9. My facial skin appears less dull and more radiant immediately after using the product. a. Strongly Agree

b. Agree

c. Neutral

d. Disagree


10. The product immediately improved the appearance of my facial skin, illuminating my complexion with a fresh youth infused glow. a. Strongly Agree

b. Agree

c. Neutral

d. Disagree


11. The product immediately enhanced the overall appearance of my facial skin. a. Strongly Agree

b. Agree

c. Neutral

d. Disagree



CASE REPORT FORM


June 15, 2015


Subject Initials

Subject Number




Tech Initials:

12. I did not experience any irritation after product application a. Strongly Agree

b. Agree

c. Neutral

d. Disagree


13. I immediately felt there was a relief in my actinic keratosis (scaly, crusty lesion) a. Strongly Agree

b. Agree

c. Neutral

d. Disagree


f. Not Applicable – I do not have actinic keratosis

CASE REPORT FORM

Subjective Questionnaire Week 1

June 22, 2015


Subject Initials

Subject Number


This CRF has been reviewed for completion prior to subject’s dismissal from station Tech Initials: WEEK 1


Tech Initials:

Please rate the level of agreement to the statements after one week of using the test products (regimen) using the rating scales provided below. Be sure to answer every question. 1. The regimen reduced the capillary redness of my facial skin.

a. Strongly Agree

b. Agree

c. Neutral

d. Disagree


2. The regimen improved the laxity (droopiness) of my eyelid skin. a. Strongly Agree

b. Agree

c. Neutral

d. Disagree


3. The regimen improved the firmness of my facial skin. a. Strongly Agree

b. Agree

c. Neutral

d. Disagree



CASE REPORT FORM


June 22, 2015


Subject Initials

Subject Number




Tech Initials:

4. The regimen improved the elasticity of my facial skin. a. Strongly Agree

b. Agree

c. Neutral

d. Disagree


5. The regimen lifted my facial skin and improved the appearance of sagging in my face a. Strongly Agree

b. Agree

c. Neutral

d. Disagree


6. The regimen tightened my facial skin a. Strongly Agree

b. Agree

c. Neutral

d. Disagree


7. The regimen improved the appearance of lines/wrinkles on my crow’s feet area. a. Strongly Agree

b. Agree

c. Neutral

d. Disagree



CASE REPORT FORM


June 22, 2015


Subject Initials

Subject Number




Tech Initials:

8. The regimen reduced the appearance of lines/wrinkles on my facial skin.

a. Strongly Agree

b. Agree

c. Neutral

d. Disagree


9. My facial skin appears less dull and more radiant after using the regimen. a. Strongly Agree

b. Agree

c. Neutral

d. Disagree


10. The regimen improved the appearance of my facial skin, illuminating my complexion with a fresh youth infused glow. a. Strongly Agree

b. Agree

c. Neutral

d. Disagree


11. The regimen enhanced the overall appearance of my facial skin. a. Strongly Agree

b. Agree

c. Neutral

d. Disagree



CASE REPORT FORM


June 22, 2015


Subject Initials

Subject Number




Tech Initials:

12. I did not experience any irritation after using the regimen for one week. a. Strongly Agree

b. Agree

c. Neutral

d. Disagree


13. I felt there was a relief in my actinic keratosis (scaly, crusty lesion) after using the regimen for one week. a. Strongly Agree

b. Agree

c. Neutral

d. Disagree



CASE REPORT FORM


July 13, 2015


Subject Initials

Subject Number




Tech Initials:

Please rate the level of agreement to the statements after four week of using the test products (regimen) using the rating scales provided below. Be sure to answer every question. 1. The regimen reduced the capillary redness of my facial skin.

a. Strongly Agree

b. Agree

c. Neutral

d. Disagree



b. Agree

c. Neutral

d. Disagree



b. Agree

c. Neutral

d. Disagree



CASE REPORT FORM


July 13, 2015


Subject Initials

Subject Number




Tech Initials:


b. Agree

c. Neutral

d. Disagree



b. Agree

c. Neutral

d. Disagree



b. Agree

c. Neutral

d. Disagree



b. Agree

c. Neutral

d. Disagree



CASE REPORT FORM


July 13, 2015


Subject Initials

Subject Number




Tech Initials:


a. Strongly Agree

b. Agree

c. Neutral

d. Disagree



b. Agree

c. Neutral

d. Disagree



b. Agree

c. Neutral

d. Disagree



b. Agree

c. Neutral

d. Disagree



CASE REPORT FORM


July 13, 2015


Subject Initials

Subject Number




Tech Initials:

12. I did not experience any irritation after using the regimen for four weeks. a. Strongly Agree

b. Agree

c. Neutral

d. Disagree


13. I felt there was a relief in my actinic keratosis (scaly, crusty lesion) after using the regimen for four weeks. a. Strongly Agree

b. Agree

c. Neutral

d. Disagree



CASE REPORT FORM


August 10, 2015


Subject Initials

Subject Number




Tech Initials:

Please rate the level of agreement to the statements after eight weeks of using the test products (regimen) using the rating scales provided below. Be sure to answer every question. 1. The regimen reduced the capillary redness of my facial skin.

a. Strongly Agree

b. Agree

c. Neutral

d. Disagree



b. Agree

c. Neutral

d. Disagree



b. Agree

c. Neutral

d. Disagree



CASE REPORT FORM


August 10, 2015


Subject Initials

Subject Number




Tech Initials:


b. Agree

c. Neutral

d. Disagree



b. Agree

c. Neutral

d. Disagree



b. Agree

c. Neutral

d. Disagree



b. Agree

c. Neutral

d. Disagree



CASE REPORT FORM


August 10, 2015


Subject Initials

Subject Number




Tech Initials:


a. Strongly Agree

b. Agree

c. Neutral

d. Disagree



b. Agree

c. Neutral

d. Disagree



b. Agree

c. Neutral

d. Disagree



b. Agree

c. Neutral

d. Disagree



CASE REPORT FORM


August 10, 2015


Subject Initials

Subject Number




Tech Initials:

12. I did not experience any irritation after using the regimen for eight weeks. a. Strongly Agree

b. Agree

c. Neutral

d. Disagree


13. I felt there was a relief in my actinic keratosis (scaly, crusty lesion) after using the regimen for eight weeks. a. Strongly Agree

b. Agree

c. Neutral

d. Disagree




CONFIDENTIAL Appendix III

Appendix III

Case Report Forms

CASE REPORT FORM

Tracking Form Screening/ Washout


Subject Initials

Subject Number


This CRF has been reviewed for completion prior to subject’s dismissal from study visit Tech Initials:

SCREENING: Page 1 of 4

TOTAL: Page 1 of 4

Subject Signature:

Screening/ Washout: June 8, 2015 Tech Time

Arrival at site

Subjects complete informed consent and model release and medical history

Inclusion / Exclusion criteria checked (NOT VAS – To be checked at BL)

Dispense washout products (Dove Beauty Bar – White and Dual Purpose Treatment Moisture with SPF 15) and washout instructions

All CRFs reviewed for completion

Subjects dismissed from visit

CASE REPORT FORM

Medical History Screening/ Washout


Subject Initials

Subject Number




TOTAL: Page 2 of 4

Please fill out the following form completely, if you need assistance please speak with an IRSI Technician.

Name:

Last: First: MI:

Date: / /

Height:

Ft. In.

Weight

Lbs.

Date of Birth:

Mo. Day Year

Age: Sex: Male Female

Ethnicity: Hispanic or Latino Not Hispanic or Latino

Race: American Indian or Alaska Native Asian (circle one: Far East, Southeast Asia, Indian subcontinent) Black or African American Native Hawaiian or Other Pacific Islander White Other____________

Facial Skin Type: Normal Oily Dry Combination

Body Skin Type: Normal Dry Very Dry

Fitzpatrick Skin Type: (see examples)

Type I Type IV

Type II Type V

Type III Type VI

Do you have Sensitive Skin? YES NO

Do you have Sensitive Eyes?

YES NO

Do you wear contact lenses? YES NO

Occupation: Retired Homemaker Unemployed Employed, Job Title: 1. Do you have any of the

following: Yes No

2. Have you had a reaction to any of the following:

Yes No

Asthma or emphysema Fragrances and Perfumes

Hay Fever or seasonal allergies Creams

Food allergies Moisturizers

Eczema or Psoriasis Soaps

Thyroid Problems Other body products

High Cholesterol Cosmetics

Diabetes, if yes: Sunscreens

A .Insulin Dependent NA If “yes” any of the above, please explain below:

B. Non-Insulin Dependent NA

Eye disease or condition

High Blood Pressure

Are you pregnant, nursing a child or planning on becoming pregnant during this study? Yes No NA

3. What method of birth control are you currently using? Tubal Ligation NuvaRing Norplant

Hysterectomy Depo Provera Abstinence

Diaphragm Birth Control Pill Post-Menopausal

IUD Condom Other

List Medications taken within the past thirty (30) days. Please include prescription drugs, vitamins, skin treatments, herbal remedies, allergy medications, antihistamines, steroids, antibiotics, anti-inflammatory drugs, antacids, and contraceptives:

If no medications have been taken in the past thirty (30) days, check here

Medications

Name of Medication Dose Reason for taking Medication Date

Ongoing Start Stop

This form reflects all medical information up to the first day of this study. Notify our staff if there is any change in this information.

Inclusion / Exclusion Screening / Washout


Subject Initials

Subject Number

This CRF has been reviewed for completion prior to subject’s dismissal from station Tech Initials:



TOTAL: Page 3 of 4

INCLUSION CRITERIA If any box is checked “No”, subject is NOT eligible to continue study. YES NO

1. Is the subject a female in good general health, and between ages 35 and 59 years old, inclusive at enrollment?

2.

Does the Subject have line and wrinkles and eyelid laxity as determined by an expert grader at Baseline visit:

a. Score of ≥2 on 10 cm VAS for lines and wrinkles (Crow’s Feet)? b. Score of ≥2 on 10 cm VAS for eyelid laxity?

*The response to this criteria is recorded on the Baseline CRF at the Baseline Visit

3.

A portion of the panel (approximately n=10) with capillary visibility (telangiectasia) Does the subject have:

a. Score of ≥2 on 10 cm VAS for capillary visibility *The response to this criteria is recorded on the Baseline CRF at the Baseline Visit

4.

A portion of the panel (approximately n=10) with actinic keratosis as determined by an expert grader at Baseline:

b. Score of ≥2 on 10 cm VAS for actinic keratosis severity *The response to this criteria is recorded on the Baseline CRF at the Baseline Visit

5. Is the subject willing to be photographed and to sign a photograph release form?

6. Is the Subject able to read, understand and willing to sign an ICF, including HIPAA and state requirements, complete a brief personal medical/history?

7.

Is the subject dependable and willing to attend study visits and comply with all study instructions and requirements, including but not limited to:

a. Willing to abstain from any other superficial or deep facial procedure during the study (dermabrasion, microdermabrasion, peels, photo facials, laser treatment, facial lesion removal, etc.)?

b. Willing to abstain from use of all other topical products for the duration of the washout period and study period?

c. Willing to abstain from the use of tanning bed use and recreational sun exposure on the face for the duration of the washout and study period?

EXCLUSION CRITERIA If any box is checked “Yes”, subject is NOT eligible to continue study. YES NO

1. Is the subject using systemic or topical steroids, Accutane, oral or topical estrogens, and/or other medicines affecting skin in a major way during study period or washout period?

2. Does the subject have present or previous inflammatory or other skin diseases, such as rosacea, severe acne, Systemic Lupus Erythematosus (SLE), dermatomyositis, scleroderma, etc.?

3. Is the subject currently smokers or are smokers within one month prior to enrollment?

4. Is the subject participating in any other clinical trials?

Exclusion Criteria continued on next page

Screening/ Washout: June 8, 2015 Tech

Inclusion / Exclusion criteria checklist

Inclusion / Exclusion Screening / Washout


Subject Initials

Subject Number




TOTAL: Page 4 of 4

EXCLUSION CRITERIA - Continued

If any box is checked “Yes”, subject is NOT eligible to continue study. YES NO

5.

Does the subject have an acute or chronic disease or medical condition, including dermatological problems, which could put her at risk in the opinion of the Principal Investigator or compromise study outcomes? Typical uncontrolled chronic or serious disease and conditions which would prevent participation in any clinical trial are cancer, AIDS, diabetes, morbid obesity, renal impairment, mental illness, drug/alcohol addiction.

6. Is the subject unreliable or unlikely to be available for the duration of the study?

7. Does the subject have history of allergic reaction, skin sensitization and/or know allergies to cosmetic ingredients, toiletries, sunscreens, etc.?

7. Has the subject been using oral contraception for less than three months before the screening visit or who has changed her contraceptive method within the three months before the Baseline visit or planning to modify her contraception treatment within the duration of the study?

8. Is the subject immunocompromised?

9. Is the subject a woman who started Hormone Replacement Therapy within the last three months preceding the screening visit?

10. Is the subject a woman using oral contraception for less than three months before the screening visit or who has changed her contraception method within the three months before the Baseline Visit or planning to modify her contraception treatment within the duration of the study?

11. Is the subject known to be pregnant, lactating or planning to become pregnant within six months? Subjects who become pregnant during the study must inform the Principal Investigator immediately.

12. Is the subject unable to communicate or cooperate with the Principal Investigator due to language problems, poor mental development, or impaired cerebral function?

13. Is the subject an employee of IRSI or other testing firms/laboratories, cosmetic or raw goods manufacturers or suppliers?

Based on the above inclusion/ exclusion criteria, does the subject qualify?

CASE REPORT FORM

Tracking Form Baseline


Subject Initials

Subject Number


This CRF has been reviewed for completion prior to subject’s dismissal from the station Tech Initials:

BASELINE: Page 1 of 9


TOTAL: Page 1 of 31

ENROLLED SUBJECTS REMAIN ONSITE FOR IMMEDIATE ASSESSMENTS

Subject Signature:

Baseline: June 15, 2015 Tech Time

Arrive at site/15 minute acclimation period (face) Arrival Time:

Equil:

Compliance check (Inclusion / Exclusion) Subject Compliant?

Circle One

Yes No

Medical History review, questioned for AEs

AE Reported? Circle One

Yes No

Expert Grader Assessments (VAS) Also check inclusion criteria

No. of Assessments: TOTAL 8

Expert Grader Assessments (VAS )Also check inclusion criteria

Subject chosen for capillary visibility portion? N=10

Circle One

Yes No

Expert Grader Assessments (VAS )Also check inclusion criteria

Subject chosen for actinic keratosis portion? N=10

Circle One

Yes No

Subject status: Circle One

Enrolled Disqualified

Imaging: Clarity™ 2D Research Ti Imaging (F, L, R view)

Subject chosen for sub-group? N=5

Circle One

Yes No

Instrumental Evaluation: Cosmetrics

Instrumental Evaluation: Cutometer

Dispense products, diary, verbal and written use instructions

In clinic product application under supervision


CASE REPORT FORM

Medical History and AEs Baseline

Study Number 3906LP0115

Subject Initials

Subject Number



Baseline: Page 2 of 9


TOTAL: Page 2 of 31

Baseline: June 15, 2015 Tech

Medical history and AEs

List any changes to medical history mentioned by the Subject, including but not limited to medications taken:

Any AEs or SAEs to report?

Circle One

Yes* No

*If yes, fill out AE form

Compliance Baseline


Subject Initials

Subject Number


Baseline: Page 3 of 9


TOTAL: Page 3 of 31

Compliance If any box is checked “No”, subject is NOT eligible to continue study. YES NO

1. Subject has arrived for Baseline visit having cleansed face within 1 hour prior to study visit?

2. Subject has used the support products as instructed?

3. Subject has not used any topical cleansers and skin treatment products (other than those assigned during the stud) on the face? This includes, but is not limited to moisturizers, serums, cleansers and medicated creams.

Applicable INCLUSION CRITERIA

If any box is checked “No”, subject is NOT eligible to continue study. YES NO

1.

Does the subject have lines and wrinkles and eyelid laxity as determined by an expert grader at Baseline?

a. Score of ≥ 2 cm on 10 cm VAS for lines/wrinkles (crow’s feet)? b. Score of ≥2 cm on 10 cm VAS for eyelid laxity?

2.

A portion of the panel (approximately n=10) with Capillary visibility (telangiectasia)

a. Score of ≥ 2 cm on 10 cm VAS for capillary visibility?

3.

A portion of the panel (approximately n=10) with actinic keratosis as determined by an expert grader at Baseline:

b. Score of ≥ 2 cm on 10 cm VAS for actinic keratosis visibility?

Applicable EXCLUSION CRITERIA

If any box is checked “Yes”, subject is NOT eligible to continue study. YES NO

1.

Has the subject been using oral contraception for less than three months before the screening visit or who has changed her contraceptive method within the three months before the Baseline visit or planning to modify her contraception treatment within the duration of the study?

Based on the above compliance questions and applicable inclusion/ exclusion criteria, does the subject qualify to continue?


Compliance (Applicable Inclusion / Exclusion) checklist

Expert Visual Grading Baseline


Subject Initials

Subject Number




TOTAL: Page 4 of 31

Texture/Smoothness - Visual

SCORE:

0 cm

10 cm

Smooth, refined even surface appearance

Rough, uneven

surface appearance

Fine Lines/Wrinkles (crow’s feet)

SCORE:

0 cm 10 cm None Must have score of ≥2 cm to qualify

Qualifies___ Does not Qualify___

Numerous, lines/Wrinkles –

Severe, Deep

Radiance/Luminosity

SCORE:

0 cm

10 cm

Radiant, Luminous Dull/Matte

Appearance And/or Sallow

Eyelid Laxity

SCORE:

0 cm Taut

“Awake”

Must have score of ≥2 cm to qualify Qualifies___ Does not Qualify___

10 cm Sagging “Tired”

Smooth Eyelid Drooping Eyelid


SCORE:

0 cm Good stretch

10 cm Poor Stretch

And Bounce back And Bounce back


VAS FACE No. of Assessments: 9

Expert Visual Grading Baseline


Subject Initials

Subject Number




TOTAL: Page 5 of 31

Overall Appearance

SCORE:

0 cm

Vibrant Healthy Appearance

10 cm Aged, Unhealthy

Appearance


SCORE:

0 cm None

□ – NA * Only grade if subject presents this at Baseline

(portion of Panel)

10 cm Highly visible,



0 cm 10 cm

SCORE:

Radiant, None

□– NA * Only grade if subject presents this at Baseline

(portion of Panel)


Photography Clarity 2D


Subject Initials

Subject Number




TOTAL: Page 6 of 31

SUBJECT SELECTED FOR CLARITY SUBGROUP? YES NO ALL THREE IMAGING POSITIONS WILL BE TAKEN AT ALL TIMEPOINTS (RIGHT/FRONT/LEFT) Baseline/June 15, 2015

1. Subject has no makeup residue on face? ___Yes ___No

2. Subject’s headband and cape is properly placed? ___Yes ___No

CLARITY 2D RESEARCH TI IMAGING Tech

Measurement of table height _______ inches

Forehead rest position

Chin rest position

Images reviewed prior to subject leaving Clarity Station to include quality of

image, position and facial expression

*Images should be taken with eyes closed

Week 1/June 22, 2015 1. Subject has no makeup residue on face? ___Yes ___No





Chin rest position


image, position and facial expression (as compared to Baseline Images)


Photography Clarity 2D


Subject Initials

Subject Number




TOTAL: Page 7 of 31

Week 4/ July 13, 2015 1. Subject has no makeup residue on face? ___Yes ___No





Chin rest position




Week 8/ August 10, 2015 1. Subject has no makeup residue on face? ___Yes ___No





Chin rest position




Face Map


Subject Initials

Subject Number




TOTAL: Page 8 of 31

Instructions: Using a ruler, identify the location where measurement will be taken. When possible at least two anatomical locations should be used to indicate the measurement location. The type of measurement should be clearly indicated

Marker Tech Evaluation

* Cosmetrics

+ Cutometer

Instrumental Evaluation Baseline


Subject Initials

Subject Number




TOTAL: Page 9 of 31

Baseline: June 15, 2015 Tech Cutometer Duplicate measurement on cheek.

Test Site Location LEFT or RIGHT Cheek

Circle One Wiping Performed: ☐ YES ☐ NO

Randomized YES Template Attached: Face Map

Cutometer measurements recorded using EDC.

Baseline: June 15, 2015 Tech Cosmetrics SIAscope Duplicate measurements on a designated site Note: Take measurement on the cheek where red capillaries are visible if applicable. For subjects without visible capillaries, take the measurement on the cheek of choice and mark on the face map.



Randomized NO Template Attached: Face Map

Hemoglobin

Cheek Measurement 1

Mean: Std. Dev:

Hemoglobin

Cheek Measurement 2

Mean: Std. Dev:

Tracking Form Immediate Post Application


Subject Initials

Subject Number



IMMEDIATE: Page 1 of 4


TOTAL: Page 10 of 31

Immediate Post Application (T15M): June 15, 2015 Tech Time

Expert Grader Assessments (VAS) No. of Assessments: TOTAL 8

Expert Grader Assessments (VAS) Subject chosen for capillary visibility portion? N=10

Circle One

Yes No

Expert Grader Assessments (VAS) Subject chosen for actinic keratosis portion? N=10

Circle One

Yes No

Instrumental: Cutometer


All CRFs and questionnaires reviewed for completion

Subject dismissed from test site, subject reminded of Week 1 visit

Expert Visual Grading Immediate Post Application


Subject Initials

Subject Number


Immediate: Page 2 of 4




SCORE:

0 cm

10 cm


Rough, uneven

surface appearance


SCORE:

0 cm 10 cm None Numerous,

lines/Wrinkles –Severe, Deep

Radiance/Luminosity

SCORE:

0 cm

10 cm



Eyelid Laxity

SCORE:

0 cm Taut

“Awake”




SCORE:

0 cm Good stretch

10 cm Poor Stretch


Immediate (T15M): June 15, 2015 Tech

VAS FACE No. of Assessments: 9

Expert Visual Grading Immediate Post Application


Subject Initials

Subject Number





Overall Appearance

SCORE:

0 cm



Appearance


SCORE:

0 cm None


(portion of Panel)




0 cm 10 cm

SCORE:

Radiant, None


(portion of Panel)


Instrumental Evaluation Immediate Post Application


Subject Initials

Subject Number





Immediate (T15M): June 15, 2015 Tech Cutometer Duplicate measurements on cheek.





Tracking Form Week 1


Subject Initials

Subject Number



WEEK 1: Page 1 of 6


Subject Signature:

Week 1: June 22, 2015 Tech Time

Arrive at site/15 minute acclimation period (face)

Arrival Time:

Equil:

Complete and Review Subjective Questionnaire

Compliance check (Inclusion / Exclusion) Review diary/Inspect test products

Subject Compliant?

Circle One

Yes No



Yes No


Expert Grader Assessments


Circle One

Yes No



Circle One

Yes No



Circle One

Yes No




CASE REPORT FORM

Medical History and AEs Week 1


Subject Initials

Subject Number



WEEK 1: Page 2 of 6



Week 1: June 22, 2105 Tech




Circle One

Yes* No


CASE REPORT FORM

Compliance Week 1


Subject Initials

Subject Number



WEEK 1: Page 3 of 6




1. Subject has arrived for Week 1 Visit having cleansed face within 1 hour prior to study visit?

2. Subject has used the support and test products as instructed?





CASE REPORT FORM

Expert Visual Grading Week 1


Subject Initials

Subject Number



Week 1: Page 4 of 6




SCORE:

0 cm

10 cm


Rough, uneven

surface appearance


SCORE:



Radiance/Luminosity

SCORE:

0 cm

10 cm



Eyelid Laxity

SCORE:

0 cm Taut

“Awake”




SCORE:

0 cm Good stretch

10 cm Poor Stretch



VAS- FACE No. of Assessments: 8

CASE REPORT FORM



Subject Initials

Subject Number



Week 1: Page 5 of 6



Overall Appearance

SCORE:

0 cm



Appearance


SCORE:

0 cm None


(portion of Panel)




0 cm 10 cm

SCORE:

Radiant, None


(portion of Panel)


Instrumental Evaluations Week 1


Subject Initials

Subject Number



WEEK 1 : Page 6 of 6



Week 1: June 22, 2015 Tech Cutometer Duplicate measurements on cheek.





Week 1: June 22, 2015 Tech Cosmetrics SIAscope Duplicate measurements on a designated site Note: Take measurement on the cheek where red capillaries are visible if applicable. For subjects without visible capillaries, take the measurement on the cheek of choice and mark on the face map.




Hemoglobin

Cheek Measurement 1

Mean: Std. Dev:

Hemoglobin

Cheek Measurement 2

Mean: Std. Dev:



Subject Initials

Subject Number



WEEK 4 : Page 1 of 6



Subject Signature:

Week 4: July 13, 2015 Tech Time


Equil:



Subject Compliant?

Circle One

Yes No



Yes No




Circle One

Yes No



Circle One

Yes No



Circle One

Yes No




CASE REPORT FORM



Subject Initials

Subject Number



WEEK 4: Page 2 of 6



Week 4: July 13, 2015 Tech




Circle One

Yes* No


CASE REPORT FORM

Compliance Week 4


Subject Initials

Subject Number



WEEK 4: Page 3 of 6










CASE REPORT FORM



Subject Initials

Subject Number



Week 4: Page 4 of 6




SCORE:

0 cm

10 cm


Rough, uneven

surface appearance


SCORE:



Radiance/Luminosity

SCORE:

0 cm

10 cm



Eyelid Laxity

SCORE:

0 cm Taut

“Awake”




SCORE:

0 cm Good stretch

10 cm Poor Stretch




CASE REPORT FORM



Subject Initials

Subject Number



Week 4: Page 5 of 6



Overall Appearance

SCORE:

0 cm



Appearance


SCORE:

0 cm None


(portion of Panel)




0 cm 10 cm

SCORE:

Radiant, None


(portion of Panel)


Instrumental Evaluation Week 4


Subject Initials

Subject Number



WEEK 4: Page 6 of 6


Week 4: July 13, 2015 Tech Cutometer Duplicate measurements on cheek.





Week 4: July 13, 2015 Tech Cosmetrics SIAscope Duplicate measurements on a designated site Note: Take measurement on the cheek where red capillaries are visible if applicable. For subjects without visible capillaries, take the measurement on the cheek of choice and mark on the face map.




Hemoglobin

Cheek Measurement 1

Mean: Std. Dev:

Hemoglobin

Cheek Measurement 2

Mean: Std. Dev:



Subject Initials

Subject Number



WEEK 8: Page 1 of 6


Subject Signature:

Week 8: August 10, 2015 Tech Time


Equil:



Subject Compliant?

Circle One

Yes No



Yes No




Circle One

Yes No



Circle One

Yes No



Circle One

Yes No




CASE REPORT FORM



Subject Initials

Subject Number



WEEK 8: Page 2 of 6



Week 8: August 10, 2015 Tech




Circle One

Yes* No


CASE REPORT FORM

Compliance Week 8


Subject Initials

Subject Number



WEEK 8: Page 3 of 6










CASE REPORT FORM



Subject Initials

Subject Number



Week 8: Page 4 of 6




SCORE:

0 cm

10 cm


Rough, uneven

surface appearance


SCORE:



Radiance/Luminosity

SCORE:

0 cm

10 cm



Eyelid Laxity

SCORE:

0 cm Taut

“Awake”




SCORE:

0 cm Good stretch

10 cm Poor Stretch




CASE REPORT FORM



Subject Initials

Subject Number



Week 8: Page 5 of 6



Overall Appearance

SCORE:

0 cm



Appearance


SCORE:

0 cm None


(portion of Panel)




0 cm 10 cm

SCORE:

Radiant, None


(portion of Panel)


CASE REPORT FORM

Instrumental Evaluations Week 8


Subject Initials

Subject Number


WEEK 8: Page 6 of 6



Week 8: August 10, 2015 Tech Cutometer Duplicate measurements on cheek.





Week 8: August 10, 2015 Tech Cosmetrics SIAscope Duplicate measurements on a designated site Note: Take measurement on the cheek where red capillaries are visible if applicable. For subjects without visible capillaries, take the measurement on the cheek of choice and mark on the face map.




Hemoglobin

Cheek Measurement 1

Mean: Std. Dev:

Hemoglobin

Cheek Measurement 2

Mean: Std. Dev:

Temperature and Humidity Log

FORM Number: 035 Version: Implementation Date: Theoretical Withdraw Date:

1.0 11/6/2013 11/6/2015

This CRF has been reviewed for completion prior to completion of the study visit Tech Initials _______

Page 1 of 17

Instructions: Indoor temperature and humidity will be recorded every hour for studies involving temperature/humidity sensitive evaluations. For all studies, outdoor temperature and humidity conditions will be recorded each day and indoor temperature and humidity will be recorded at three time intervals, prior to first subject arrival/acclimation, halfway through the study visit, and upon completion of the study visit. A temperature and humidity log should be used for each room used in the study.


VISIT BASELINE/T15M JUNE 15, 2015

OUTDOOR CONDITIONS

TEMPERATURE (°F) HUMIDITY (%RH)

High: High:

Low: Low:

Average: Average:

Source:

INDOOR CONDITIONS

ROOM:

RECEPTION AREA

DEVICE NUMBER:

TIME TEMPERATURE (°F) HUMIDITY (%RH) TECHNICIAN

INITIALS



1.0 11/6/2013 11/6/2015


Page 2 of 17



INDOOR CONDITIONS

ROOM: TREATMENT 1

(VISUALS) DEVICE

NUMBER:


INITIALS



1.0 11/6/2013 11/6/2015


Page 3 of 17



INDOOR CONDITIONS

ROOM: TREATMENT 2

(CUTOMETER/COSMETRICS) DEVICE

NUMBER:

TIME TEMPERATURE (°F) HUMIDITY

(%RH) TECHNICIAN

INITIALS



1.0 11/6/2013 11/6/2015


Page 4 of 17



ROOM: TREATMENT 3

(IMAGING) DEVICE

NUMBER:

TIME TEMPERATURE (°F) HUMIDITY (%RH) TECHNICIAN INITIALS



1.0 11/6/2013 11/6/2015


Page 5 of 17



ROOM: TREATMENT 4

(PRODUCT) DEVICE

NUMBER:




1.0 11/6/2013 11/6/2015


Page 6 of 17



VISIT WEEK 1 JUNE 22, 2015

OUTDOOR CONDITIONS


High: High:

Low: Low:

Average: Average:

Source:

INDOOR CONDITIONS

ROOM:

RECEPTION AREA

DEVICE NUMBER:


INITIALS



1.0 11/6/2013 11/6/2015


Page 7 of 17



INDOOR CONDITIONS

ROOM: TREATMENT 1

(VISUALS) DEVICE

NUMBER:


(%RH) TECHNICIAN

INITIALS



1.0 11/6/2013 11/6/2015


Page 8 of 17



ROOM: TREATMENT 2


NUMBER:




1.0 11/6/2013 11/6/2015


Page 9 of 17



ROOM: TREATMENT 3

(IMAGING) DEVICE

NUMBER:




1.0 11/6/2013 11/6/2015


Page 10 of 17



VISIT WEEK 4 JULY 13, 2015

OUTDOOR CONDITIONS


High: High:

Low: Low:

Average: Average:

Source:

INDOOR CONDITIONS

ROOM:

RECEPTION AREA

DEVICE NUMBER:


INITIALS



1.0 11/6/2013 11/6/2015


Page 11 of 17



INDOOR CONDITIONS

ROOM: TREATMENT 1

(VISUALS) DEVICE

NUMBER:


(%RH) TECHNICIAN

INITIALS



1.0 11/6/2013 11/6/2015


Page 12 of 17



ROOM: TREATMENT 2


NUMBER:




1.0 11/6/2013 11/6/2015


Page 13 of 17



ROOM: TREATMENT 3

(IMAGING) DEVICE

NUMBER:




1.0 11/6/2013 11/6/2015


Page 14 of 17



VISIT WEEK 8 AUGUST 10, 2015

OUTDOOR CONDITIONS


High: High:

Low: Low:

Average: Average:

Source:

INDOOR CONDITIONS

ROOM:

RECEPTION AREA

DEVICE NUMBER:


INITIALS



1.0 11/6/2013 11/6/2015


Page 15 of 17



ROOM: TREATMENT 1

(VISUAL) DEVICE

NUMBER:




1.0 11/6/2013 11/6/2015


Page 16 of 17



ROOM: TREATMENT 2


NUMBER:




1.0 11/6/2013 11/6/2015


Page 17 of 17



ROOM: TREATMENT 3

(IMAGING) DEVICE

NUMBER:


Reimbursement Form


Subject Initials

Subject Number

PLEASE PRINT CLEARLY, FILL IN ALL FORM FIELDS DO NOT WRITE IN SHADED AREAS

- - Social Security Number

First Name M.I. Last Name

Street Apt. /Suite

City / Town State Zip Code

39310SM0415

$ 175.00

Department / Study Amount

Payment Terms: Please read ClinCard information. I_____________________________ have received my payment and agree to the ClinCard terms. Sign your name


CONFIDENTIAL Appendix IV

Appendix IV

Informed Consent Form and Photograph Release Form

INFORMED CONSENT FORM Study Number: 3931OSM0415

An Eight-Week Clinical Study to Evaluate the Efficacy of One

Product on Skin Condition (Catalyst AC-11)

Date of ICF Approval REVISED - June 15, 2015

Subject Initials: _______

Page 1 of 8

This consent form may contain word(s) that you do not understand. Please ask the study staff to explain any word(s) or information that you do not clearly understand. You are entitled to a copy of this Consent Form and one will be provided to you today.

1.0 PURPOSE

You are being asked to participate in a research study to assess and compare the effects of three formulations compared to a vehicle control on facial skin appearance and condition. This study is also being conducted to evaluate the facial skin tolerance of the three formulations.

2.0 ENROLLMENT

Certain enrollment criteria are required for this study. If you do not meet these criteria you will not be enrolled in this study. Below is a list of enrollment requirements.

Inclusion Criteria


2. Subjects with lines and wrinkles and eyelid laxity as determined by an expert grader at Baseline. a. Score of ≥2 cm on 10 cm VAS for fine lines/wrinkles (crow’s feet) b. Score of ≥2 cm on 10 cm VAS for eyelid laxity

3. A portion of the panel (approximately n=10) with Capillary visibility (telangiectasia) a. Score of ≥2 cm on 10 cm VAS for capillary visibility

4. A portion of the panel (approximately n=10) with actinic keratosis as determined by an expert grader at baseline.

a. Score of ≥2 cm on 10 cm VAS for actinic keratosis severity 5. Willing to be photographed and sign a photograph release form. 6. Able to read, understand and willing to sign an ICF, including HIPAA and state requirements,


requirements, including but not limited to: a. Willing to abstain from any other superficial or deep facial procedure during the study

(dermabrasion, microdermabrasion, peels, photo facials, laser treatment, facial lesion removal, etc.).



Exclusion Criteria








Page 2 of 8

2. Subjects with present or previous inflammatory or other skin diseases, such as rosacea, severe acne,

Systemic Lupus Erythematosus (SLE), dermatomyositis, scleroderma, etc.




5. Subjects having an acute or chronic disease or medical condition, including dermatological problems,

which could put her at risk in the opinion of the Principal Investigator or compromise study

outcomes. Typical uncontrolled chronic or serious diseases and conditions which would prevent

participation in any clinical trial are cancer, AIDS, diabetes, morbid obesity, renal impairment, mental

illness, drug/alcohol addiction.


7. History of allergic reactions, skin sensitization and/or known allergies to cosmetic ingredients,

toiletries, sunscreens, etc.


9. Woman who started Hormone Replacement Therapy within the last three months preceding the

screening visit

10. Woman using oral contraception for less than three months before the screening visit or who has

changed her contraceptive method within the three months before the Baseline visit or planning to

modify her contraception treatment within the duration of the study

11. Woman known to be pregnant, lactating or planning to become pregnant within six months. Subjects

who become pregnant during the study must inform the Principal Investigator immediately

12. Individuals unable to communicate or cooperate with the Principal Investigator due to language

problems, poor mental development, or impaired cerebral function

13. Employees of IRSI or other testing firms/ laboratories, cosmetic or raw goods manufacturers or

suppliers

3.0 PROCEDURES

You are being asked to voluntarily participate in an Eight (8) Week Treatment Period study involving four (4) visits to the test site (including today’s visit). The study will also involve a washout period that is approximately seven days. The study will include approximately thirty (30) test subjects. At today’s visit you will be asked to read and sign this informed consent prior to receiving any study instructions. You will also be asked to complete a brief medical/personal history. Qualification for study participation will be evaluated by an IRSI technician using information collected from your medical history as well as an inclusion/ exclusion checklist. If you qualify at this visit, you will continue onto the washout portion of the study. Final qualification and enrollment into the study will occur at the Baseline study visit. If you qualify today, you will be given the Dove Beauty Bar, White Skin Cleanser to be used for all facial cleansing during the washout period. You will also be provided with Dual Purpose Treatment Moisture with SPF 15 to be applied daily in the morning prior to sun exposure and reapply every two hours as needed throughout






Page 3 of 8

the day during sun exposure. You will also receive instructions regarding the discontinuation of other facial skin products and other restriction during the study, along with your return visit dates. At the Baseline Visit you will be required to arrive at the testing site with a clean facial skin, having washed your face and applied no topical treatment or cosmetic products within one hour prior to your scheduled visit. Once you arrive you will be required to wait at least fifteen (15) minutes with your face exposed prior to any assessments. You will then be questioned for any changes in your medical history as well as compliance to the study instructions. You will be evaluated by a trained IRSI evaluator for signs of photodamaged skin to confirm your qualification into the study. If qualified, you will be enrolled into the study. You will then undergo non-invasive, bio-instrumental and photography evaluations. An IRSI technician will apply the test product on your face for the first time at the testing site. Approximately, fifteen minutes after application, you will again undergo non-invasive visual grading assessment and bio-instrumental evaluations. In addition, you will be asked to complete a questionnaire regarding your opinion of the product and its effects. Upon completion of post-application evaluations you will be dismissed from the Baseline visit and schedule your Week 1 (1) visit. At Week One (1) Visit, you will be required to arrive at the testing center with a clean facial skin, having washed your face, and applied no topical treatment or cosmetic products within one hour prior to your scheduled visit. Once you arrive you will be required to wait at least fifteen (15) minutes with your face exposed prior to any assessments. You will then be questioned for any changes in your medical history as well as compliance to the study instructions. You will undergo non-invasive expert visual grading, bio-instrumental and photography evaluations. In addition, you will be asked to complete a questionnaire regarding your opinion of the product and its effects. You will return the test product for inspection and your diary will be reviewed and returned to you. Upon completion of Week 1 evaluations, you will be dismissed from the Week One (1) Visit and scheduled for your Week Four (4) Visit. At Week Four (4) Visit, you will be required to arrive at the testing center with a clean facial skin, having washed your face, and applied no topical treatment or cosmetic products within one hour prior to your scheduled visit. Once you arrive you will be required to wait at least fifteen (15) minutes with your face exposed prior to any assessments. You will then be questioned for any changes in your medical history as well as compliance to the study instructions. You will undergo non-invasive expert visual grading, bio-instrumental and photography evaluations. In addition, you will be asked to complete a questionnaire regarding your opinion of the product and its effects. You will return the test product for inspection and your diary will be reviewed and returned to you. Upon completion of Week 4 evaluations, you will be dismissed from the Week four (4) visit and scheduled for your week eight (8) visit. At Week Eight (8) Visit, you will be required to arrive at the testing center with a clean facial skin, having washed your face and applied no topical treatment or cosmetic products within one hour prior to your scheduled visit. Once you arrive you will be required to wait at least fifteen (15) minutes with your face exposed prior to any assessments. You will then be questioned for any changes in your medical history as well as compliance to the study instructions. You will undergo non-invasive expert visual grading, bio-instrumental and photography evaluations. In addition, you will be asked to complete a questionnaire regarding your opinion of the product and its effects. The test product and diary will be collected and reviewed. Upon completion of Week 8 evaluations, you will receive your stipend for the study participation and you will be dismissed from the study.






Page 4 of 8

3.1 PRODUCT APPLICATION

All subjects will receive treatment in this clinical study. One topical product is being evaluated on its ability to improve skin condition. In addition to the test product, three supporting products will also be incorporated as a regimen for the duration of the study. You will use the regimen daily as per sponsor instruction for eight weeks. You will also be given Dove Beauty Bar – white to use as a facial cleanser, and Dual Purpose Treatment Moisture with SPF 15 to use as your moisturizer with SPF for the study duration. 3.2 EXPERT GRADER ASSESSMENTS

At each visit you will have your face visually evaluated by a trained expert grader or technician. Visual assessments can include how the product looks or feels on your skin or how your skin appears without product on the skin.

3.3 INSTRUMENTAL EVALUATION

At each visit, you will have your skin evaluated by bio-Intrumentation. Two instruments will be used during the study: Cosmetrics ™SIAscope and Cutometer.

The SIAscope is an optical skin imaging instrument which uses a probe to measure components of your skin, including melanin, hemoglobin and collagen. For the purposes of this study, dermal hemoglobin measurements will be taken in duplicate and averaged on a spot determined at Baseline with visible red capillaries, at Baseline, Week 1, Week 4 and Week 8. The same location will be measured at each time point and recorded using a face map. This is a painless and non-invasive procedure

The Cutometer uses the light suction to evaluate the firmness and elasticity of your skin. Two consecutive measurements will be taken on your left or right cheek following a randomization code list. Measurements will be taken at each time point: Baseline, Immediately fifteen minutes after product application (T15M), Week 1, Week 4 and Week 8 Visits.

3.4 SUBJECTIVE QUESTIONNAIRE

You will be asked to complete a questionnaire regarding your level of agreement with the statements about product performance, using a five point scale at the following time point: Week 1, Week 4 and Week 8 Visits.

3.5 PHOTOGRAPHY ASSESSMENTS

A subgroup of five (5) subjects will be randomly selected to have photographs taken of their face at Baseline, Week 1, Week 4 and Week 8 Visits. One of the full front face, one left profile and one right profile using the Clarity 2D research Ti system.






Page 5 of 8

Photographs will be for documentation purposes only. You will be required to sit with your face in a photography booth for a short period of time. A black cape and headband will be provided for you to wear during the imaging; you will be responsible for bringing the black headband to each study visit. This procedure is non-invasive and painless.

4.0 COMPENSATION

You will receive $175.00 for completing the study as directed. If you are not qualified for this study you will not be compensated. If you are present and qualified, but not enrolled due to overbooking, you will be paid $30.00. Please note that it is the policy of IRSI to overbook all studies due to high rates of cancellations and no-shows. Completing the study paperwork does not guarantee enrollment into the study, even if you meet the entry criteria and qualify. If you are discontinued from the study you will be paid on the basis of the visits you have completed at $30.00 per visit.

If you withdraw from this study for personal reasons unrelated to the test materials, you will not be compensated. If you are disqualified for refusal to obey rules, follow instructions or attend all visits as scheduled, you will not be compensated.

This is a voluntary study and you may withdraw at any time without obligation or prejudice. The sponsor and/or investigative staff may remove you from this study at any time for any reason without loss of benefits, except as stated above.

Payment will be by Clincard within approximately 24 hours of the final study visit if not available the day of the final visit.

5.0 POTENTIAL BENEFIT

You may notice an improvement in your facial skin condition during the eight (8) week treatment period. However, the amount is unknown and will vary among participants.

6.0 POTENTIAL RISKS

The test product is for you ONLY to use. The product is for external use only.

You may develop irritation on your face. If a study area becomes irritated, you should contact IRSI immediately. It is possible to develop a reaction to products such as those being tested and the cleanser being used throughout the study period including but not limited to stinging, redness, dryness, flaking, burning, rash and itching. Some risks are unknown and you will be advised if more information becomes available.

If you have a history of reactions to cosmetics or moisturizing products you must not participate in this study. If you have no history of sensitivity the likelihood of a reaction is minimal and similar to that if you purchased and used comparable products on your own.

Reactions, if any, usually occur at or around the test area(face) but are not limited to these areas. Reactions may persist in some individuals. In the event of a reaction you should immediately contact:






Page 6 of 8

Robigaile, Study Coordinator at (914) 937-6500, Ext. 132

In the event of a medical emergency, you should seek medical attention first and then contact IRSI.

If you experience an injury as a direct result of administration of the test material, the study sponsor agrees to pay medical expenses necessary to treat such injury: (1) To the extent you are not otherwise reimbursed by your own medical insurance, (2) provided you have followed the directions of the investigator before and after the injury occurred. Additional financial compensation will not be provided. Medical follow-up will be provided until the investigator or study coordinator determines you have recovered.

If you withdraw due to personal reasons related to product usage other than a response judged by IRSI staff to be a reaction to test product or instructions, you may not be paid. If, in the judgment of the investigative staff, it is best to discontinue your participation for reasons such as a documented medical condition not related to study materials, product failure or study termination, you will be paid for that portion of the study you have completed (pro rata), according to the number of scheduled visits made to the office. If your participation in the study is stopped due to an adverse reaction related to use of the test material or test instructions, you will be paid the full stipend amount.

If you are pregnant or planning on becoming pregnant or at significant risk of becoming pregnant during this test, you should not enroll in the test. Although no side effects to pregnancy are expected from the test materials the risks are unknown. If you become pregnant during the test you will immediately stop product use and notify IRSI.

For safety reasons, even if you drop from this study you may be asked to make follow-up visits to the study facility or to a physician. In the event of a reaction this is especially important for your safety and so that accurate information can be obtained.

7.0 CONFIDENTIALITY OF RECORDS

Reports prepared by IRSI use statistical information only and at no time will your name be used in these reports. The sponsor, the FDA and Allendale Investigational Review Board and others in certain legal action, may inspect the records of this study which will include your name, medical records and, if applicable, personal information relating to your participation.

By signing this consent form you authorize the release of your medical records, only for treatment of illnesses and injuries related to this study to IRSI, and the study sponsor. IRSI will not release any information in your medical records except as stated in this consent.






Page 7 of 8

8.0 USE OF PERSONAL INFORMATION (HIPAA) AUTHORIZATION

Your participation in this study will involve disclosing some of your personal data and medical information (allergies, medications, illnesses, conditions and demographics {age, sex, race, and occupation}) as well as name, address, email address, Social Security Number, and phone number to IRSI.

The Study Coordinator, Investigator or authorized staff member may ask you for this information. By signing this consent form you authorize the release of your medical records (for treatments, illnesses and injuries as a direct result of test material use) to IRSI.

The same staff and management that write IRSI’s reports will review or use the medical information you report. At no time will your name, address, phone number, email address or social security number be published in a report. The study Sponsor, the Allendale Institutional Review Board, and the FDA may be granted access to your personal information regarding this study. IRSI will use the medical information you provide in order to conduct this study.

Additionally, IRSI will use the medical information in its database so that IRSI may be able to contact you to participate in future studies. Therefore, your authorization to IRSI to use the medical information and data you provide has no end date.

You have the right to revoke this authorization so long as IRSI has not already relied on or used the information you provided for this study. At your written request, IRSI will not contact you for future studies. Only employees who have signed a confidentiality agreement are permitted to access the database. IRSI does not sell the identifying information in the database. Even if you take back your consent to participate in this study the Use of Personal Information authorization will remain in effect.

Your signature below indicates you have read the above privacy statement.

Signature:

Date:





Page 8 of 8

9.0 CONSENT OF SUBJECT

I have read and fully understand this consent and what is required of me during this study. I understand the risks, benefits and procedures and that I am free to ask questions at any time. I have no questions at this time. Additional information regarding the test material may become available to me during this study. If additional information becomes available or the study procedures are changed and this affects my well-being a new consent form will be provided to me. By signing this consent I authorize the release of my medical records in the event of an illness, injury or reaction related to this study. The investigator or a member of the staff will be available at (914) 937-6500 to answer my questions. I have read this consent and I freely and voluntarily agree to participate in this study as described to me. By signing this form I forfeit none of my legal rights.

Signature: Date:

Print Name:

Last: First: M.I:

Street Address: City: State: Zip:

Home Phone: Cell Phone: Work Phone:

E-Mail Address:

Social Security Number:

DO NOT WRITE BELOW THIS LINE

*************************************************************************************

Witness Signature: Person Administering Consent (IRSI Personnel)

Signature: Date:

Print Name:

Last: First:

Model Release Form


Subject Initials

Subject Number

Page 1 of 1

Consent given to: International Research Services, Inc. 222 Grace Church Street Port Chester, N.Y. 10573 For valuable consideration, I hereby irrevocably consent to and authorize the use and reproduction by you, or anyone authorized by you, of any and all photographs which you have taken of me, negative and positive, proofs of which are hereto attached, for any purpose whatsoever, throughout the world, without further compensation to me. All negatives and positives, together with the prints shall constitute the property of IRSI and/or the study sponsor, solely and completely. By signing below, I agree to the above statement and attest that I am 18 years of age or older at the time of study enrollment and the date of the signing of this document: Name: _______________________________________ (Please print) Model: ______________________________________ (Signature of model)

Date: ________________________________________

Address: ________________________________ _________________ _______ _________

(Street) (City) (State) (Zip) Witnessed by: _________________________________

(Signature of witness) Date: _________________________________________


CONFIDENTIAL Appendix V

Appendix IV

Randomization Code(s)

RANDOMIZATION CODE CUTOMETER

Study Number 39310SM0415

Randomization Details: Randomize location of instrument measurement

Page 1 of 1

SUBJ # Cheek SUBJ # Cheek

01 L 19 R

02 R 20 L

03 L 21 L

04 L 22 R

05 R 23 R

06 R 24 L

07 L 25 R

08 L 26 L

09 R 27 R

10 R 28 L

11 L 29 L

12 R 30 R

13 L 31 R

14 R 32 L

15 R 33 L

16 L 34 R

17 L 35 R

18 R 36 L


CONFIDENTIAL Appendix II

Appendix II

Protocol Deviations

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DN: cn=Kimberly A. Hammon, o=IRSI, ou=Quality

Assurance, [email protected], c=US

Date: 2015.10.28 10:09:24 -04'00'


CONFIDENTIAL Appendix III

Appendix III

Adverse Events


CONFIDENTIAL Appendix IV

Appendix IV

Statistical Report and Data Listing

of 117

08/31/15.3

INTERNATIONAL RESEARCH SERVICES, INC.

SKIN CONDITION STUDY #3931OSM0415

MEDICAL HISTORY

E R F B F S E L O

INI- T A A O I K Y E C

SUBJ TIAL HGT WGT AGE H C C D T I E N C SPECIFY

---- ---- ---- --- --- N E E Y Z N S S U -------------------------

01 V-G 63.0 200 48 N W N N 3 N N N U

02 L-P 67.0 160 52 N W C N 4 N N Y E T.A.

03 T-H 65.0 140 59 N W C N 3 N N Y E SPECIAL ED AIDE

04 A-B 59.0 103 35 N W N N 4 N N N H

05 L-D 64.5 190 56 N W N N 4 N N N H

06 MTI 69.0 180 56 N W C N 2 N N N E AFTERSCHOOL COORDINATOR

07 A-D 67.0 140 52 N W N N 3 N N N U

08 GPC 64.0 130 45 H C D 4 Y Y N H

09 EJG 68.0 200 37 N W N N 1 N N N E SELF (RESTAURANT)

10 R-D 60.0 103 58 N W N N 3 N N N R

12 K-P 65.0 112 46 N W D D 2 N N N E SELF - TEACHER

13 AKG 60.0 96 49 N W C N 2 N N N E LUNCH MONITOR

14 M-A 61.0 178 48 H N N 3 N N N H

15 AMI 69.0 190 57 H N N 2 N N N H

16 CMM 63.0 216 43 N W O N 5 N N N E PHLEBOTONIST

18 BDL 65.0 165 47 N W C N 3 Y Y Y E PROGRAM COORDINATOR

19 LSM 67.0 150 50 N W N N 3 N N Y E WAITRESS

20 LMM 63.0 150 55 H W C D 2 N N N E USPS MAIL HANDLER

21 S-L 64.0 240 57 N W C D 3 N N N E OFFICE MANAGER

22 CAK 68.0 200 52 N W N N 2 N N N H

23 SMS 62.0 200 48 N W N N 3 N N N U

24 L-G 64.0 220 60 N W C D 3 N N N R

25 SLM 64.0 190 49 N W D N 2 N N N H

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MEDICAL HISTORY

E R F B F S E L O

INI- T A A O I K Y E C

SUBJ TIAL HGT WGT AGE H C C D T I E N C SPECIFY

---- ---- ---- --- --- N E E Y Z N S S U -------------------------

26 J-A 63.0 169 59 N W C N 2 N Y N R

27 N-S 63.0 130 59 N W N N 3 Y Y Y U

28 D-R 62.0 170 59 H C N 4 N N N R

29 L-Z 69.0 300 58 N W C N 2 N N N R

30 J-B 66.0 173 49 N B C D 4 N N N U

31 NLA 63.5 150 58 N W D D 3 N N N H

32 BJB 61.0 150 54 N W N N 3 N N Y H

33 P-G 65.0 135 58 N W N N 3 N N N H

35 G-T 64.0 148 49 N W C D 2 Y Y N E REAL ESTATE

36 J-T 60.0 130 38 H C N 3 N N N E RECEPTIONIST

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EXPERT VISUAL GRADING

ELAS ACTINIC

EVAL TEX- FINE RADI EYELID TIC OVER CAPIL- KERA-

TIME TURE LINE ANCE LAXITY ITY ALL LARY TOSIS

------ ---- ---- ---- ------ ---- ---- ------ -------

** SUBJECT = 01

BASE 4.3 4.6 4.1 4.1 3.8 4.7 4.1

IMMED 4.0 4.1 4.1 4.0 3.4 4.3 4.2

WK-1 4.5 4.5 5.3 4.2 4.3 4.5 3.8

WK-4 4.4 3.6 3.7 3.2 3.9 4.4 4.0

WK-8 4.2 3.7 4.0 2.5 3.5 3.9 3.1

** SUBJECT = 02

BASE 4.3 4.6 5.4 4.6 3.9 5.2 3.9

IMMED 3.1 4.1 3.7 4.5 3.7 4.9 3.4

WK-1 4.4 5.3 4.8 4.9 3.8 4.9 3.1

WK-4 4.1 4.2 4.8 4.1 4.0 4.4 3.2

WK-8 3.8 3.9 3.9 3.7 3.9 4.2 2.5

** SUBJECT = 03

BASE 4.3 5.7 4.7 4.3 4.3 5.0

IMMED 3.4 4.9 3.3 4.2 4.2 4.1

WK-1 3.8 5.6 4.6 4.1 3.9 4.5

WK-4 3.9 5.4 3.6 4.5 4.5 5.2

WK-8 3.3 4.7 2.6 4.2 3.7 4.0

** SUBJECT = 04

BASE 4.3 2.5 4.5 2.3 3.7 4.1 4.0

IMMED 3.4 2.3 2.8 2.7 2.7 2.9 3.7

WK-1 4.1 2.5 3.5 2.6 3.2 4.0 3.5

WK-4 4.2 2.7 3.9 2.4 3.7 4.4 3.4

WK-8 3.4 1.3 2.0 1.8 2.5 2.3 2.1

** SUBJECT = 05

BASE 3.8 4.7 4.8 4.7 3.9 4.8 5.1

IMMED 3.3 4.5 2.8 4.3 3.8 4.9 5.2

WK-1 3.4 5.9 5.2 4.5 3.9 4.9 5.1

WK-4 3.7 5.2 3.8 3.4 3.9 4.2 4.8

WK-8 3.9 4.3 3.5 2.7 3.5 3.8 4.2

** SUBJECT = 06

BASE 4.5 5.6 5.3 4.9 4.5 5.0 4.7

IMMED 2.9 5.0 2.6 4.7 3.8 4.5 4.8

WK-1 4.3 5.8 5.7 5.6 4.8 5.2 5.3

WK-4 3.9 5.1 4.4 4.3 4.1 4.4 4.5

WK-8 3.9 4.3 3.2 4.2 3.5 4.3 3.5

** SUBJECT = 07

BASE 3.8 4.7 4.6 4.7 4.2 4.5

IMMED 3.3 4.3 2.2 4.2 3.5 4.0

WK-1 4.3 4.9 4.4 3.1 3.6 3.9

WK-4 4.3 4.2 4.2 3.8 4.1 4.3

WK-8 3.5 3.2 3.8 3.5 3.6 3.9

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ELAS ACTINIC



------ ---- ---- ---- ------ ---- ---- ------ -------

** SUBJECT = 08

BASE 4.3 3.9 4.3 2.8 3.7 4.4

IMMED 4.3 3.4 4.3 2.8 3.7 4.5

WK-1 4.0 2.5 4.0 3.3 3.6 3.8

WK-4 4.2 4.0 4.3 2.8 4.0 4.1

WK-8 3.7 2.2 3.1 3.0 3.6 3.8

** SUBJECT = 09

BASE 4.1 2.8 4.8 2.4 3.9 4.8 2.6

IMMED 2.8 2.7 2.3 2.1 3.2 3.4 2.2

WK-1 4.4 3.8 4.8 3.9 3.9 4.6 4.5

WK-4 3.4 2.8 3.9 3.4 3.4 3.2 3.2

WK-8 3.5 2.4 3.7 2.6 3.4 3.8 3.6

** SUBJECT = 10

BASE 4.9 6.4 5.4 4.6 3.8 5.2

IMMED 2.8 5.8 2.7 4.0 3.5 4.3

WK-1 5.2 5.9 5.5 5.4 4.3 5.2

WK-4 4.2 4.7 4.7 3.8 4.5 4.7

WK-8 4.0 3.9 2.8 2.8 3.9 4.2

** SUBJECT = 12

BASE 4.2 5.4 4.9 5.4 4.5 4.9

IMMED 2.7 4.6 2.4 5.1 4.1 5.0

WK-1 3.9 5.6 4.5 4.3 3.8 4.5

WK-4 4.1 5.4 4.8 4.1 4.0 4.8

WK-8 3.0 4.1 3.3 3.5 3.6 3.8

** SUBJECT = 13

BASE 4.7 4.3 4.4 2.8 3.6 4.8 4.4

IMMED 3.7 3.6 3.3 2.6 2.8 3.9 3.5

WK-1 4.2 4.5 4.5 4.0 3.9 4.5 4.1

WK-4 4.5 3.6 4.0 3.0 3.8 4.3 3.4

WK-8 3.9 3.5 1.5 2.8 2.8 3.2 2.5

** SUBJECT = 14

BASE 4.8 4.1 5.1 2.8 3.7 4.8 3.7

IMMED 4.0 3.3 2.9 2.4 3.5 4.2 3.3

WK-1 3.7 3.0 4.6 3.0 3.8 4.4 3.0

WK-4 4.4 2.3 4.1 2.9 3.9 4.2 3.3

WK-8 3.3 2.6 3.1 2.7 3.5 3.3 3.5

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ELAS ACTINIC



------ ---- ---- ---- ------ ---- ---- ------ -------

** SUBJECT = 15

BASE 4.3 4.7 5.1 4.4 4.6 5.1 3.9

IMMED 3.4 4.2 3.2 4.1 3.8 4.5 3.8

WK-1 4.2 5.3 4.7 4.0 4.0 4.6 4.5

WK-4 4.2 4.3 4.3 3.5 4.3 4.5 4.2

WK-8 4.0 3.5 2.9 3.3 3.4 4.4 2.9

** SUBJECT = 16

BASE 4.5 2.6 3.7 2.8 3.9 5.0

IMMED 2.7 2.3 3.1 2.4 3.5 4.7

WK-1 3.6 4.5 3.5 3.2 3.7 4.3

WK-4 4.4 3.8 4.1 3.0 3.9 4.5

WK-8 4.1 2.3 2.8 2.5 3.5 4.1

** SUBJECT = 18

BASE 4.4 4.2 4.7 3.2 3.8 4.4 3.1

IMMED 2.7 3.7 2.7 2.7 3.5 4.2 2.8

WK-1 4.3 5.3 5.4 3.5 3.8 4.9 3.4

WK-4 4.2 4.5 3.9 3.9 3.9 4.4 3.4

WK-8 3.4 4.0 3.5 3.0 3.1 3.8 2.7

** SUBJECT = 19

BASE 4.1 3.9 5.2 2.6 3.5 5.1 5.1

IMMED 2.8 3.1 2.8 2.5 3.2 4.4 4.9

WK-1 4.5 4.2 5.7 2.7 3.7 5.2 5.1

WK-4 4.2 3.2 4.4 3.0 4.0 4.7 4.7

WK-8 4.1 3.4 4.1 3.1 3.3 3.9 3.5

** SUBJECT = 20

BASE 4.3 3.3 5.1 2.8 3.7 4.8 3.6

IMMED 2.9 2.6 2.6 2.8 2.8 2.9 3.4

WK-1 4.0 4.5 4.2 3.5 3.7 4.2 3.5

WK-4 3.8 3.1 3.8 2.8 3.6 3.8 2.9

WK-8 2.7 2.3 2.5 2.8 3.4 3.0 3.2

** SUBJECT = 21

BASE 3.5 4.1 4.6 2.8 3.7 4.9 5.1

IMMED 2.7 3.5 2.7 3.1 3.5 3.7 4.8

WK-1 4.6 4.8 4.8 4.0 4.1 4.5 5.2

WK-4 4.2 4.6 4.3 3.9 4.2 4.4 4.2

WK-8 4.1 3.9 2.9 2.9 3.6 4.1 3.9

** SUBJECT = 22

BASE 4.1 4.2 5.1 4.2 3.9 4.7 3.9

IMMED 2.3 3.7 3.3 4.0 2.8 4.1 3.7

WK-1 4.2 5.8 5.0 4.1 4.0 5.0 4.0

WK-4 4.5 4.9 4.6 4.0 4.1 4.6 3.9

WK-8 3.8 4.2 3.5 3.1 3.5 3.7 2.8

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ELAS ACTINIC



------ ---- ---- ---- ------ ---- ---- ------ -------

** SUBJECT = 23

BASE 4.1 4.4 4.8 4.2 3.6 4.7 3.7

IMMED 2.7 3.6 3.1 3.8 3.4 3.9 3.3

WK-1 4.7 5.1 4.2 3.2 3.9 4.8 4.0

WK-4 3.9 4.2 4.0 3.7 4.0 4.6 3.1

WK-8 3.2 4.1 2.4 3.7 3.7 4.2 2.6

** SUBJECT = 24

BASE 4.4 4.8 5.2 4.3 3.6 5.2 5.8

IMMED 3.7 4.3 2.7 4.1 3.0 4.4 5.4

WK-1 4.4 5.1 4.4 2.9 3.5 4.6 5.4

WK-4 4.3 4.3 4.4 4.2 4.0 4.3 4.1

WK-8 3.0 3.9 2.4 3.5 3.6 4.0 3.9

** SUBJECT = 25

BASE 3.9 3.9 4.7 4.0 3.6 5.1 5.3 4.4

IMMED 2.2 3.6 3.3 3.7 3.3 4.6 5.1 4.1

WK-1 4.7 4.9 5.2 3.9 4.1 4.6 5.1 3.8

WK-4 4.7 4.4 5.1 4.2 4.5 4.8 4.8 3.7

WK-8 4.1 4.1 3.8 3.5 3.0 3.7 4.2 3.9

** SUBJECT = 26

BASE 4.1 4.1 4.5 4.7 4.3 4.9 4.5

IMMED 3.4 3.7 2.9 4.2 3.8 4.3 4.1

WK-1 3.8 4.3 4.4 4.2 5.0 4.5 3.9

WK-4 3.8 3.6 4.1 3.5 3.8 4.4 3.7

WK-8 2.8 3.1 3.4 3.3 3.8 3.8 3.3

** SUBJECT = 27

BASE 4.7 4.5 5.2 5.0 4.1 5.1 4.6 2.9

IMMED 4.4 4.0 4.0 4.7 3.6 5.0 4.5 2.8

WK-1 4.9 4.5 5.3 4.2 4.2 5.0 4.0 3.6

WK-4 4.3 4.0 4.4 4.2 4.1 4.4 3.9 2.7

WK-8 4.3 4.1 4.5 4.5 4.1 4.5 3.1 2.7

** SUBJECT = 28

BASE 3.5 3.8 3.9 3.9 3.7 3.8 3.6 3.3

IMMED 2.8 3.2 3.3 3.7 3.6 3.8 3.7 3.2

WK-1 4.0 4.0 3.7 2.9 3.1 4.6 3.6 3.2

WK-4 3.9 2.7 4.2 3.3 4.4 4.3 3.3 3.6

WK-8 3.1 3.3 2.9 3.1 3.0 2.7 2.5 2.6

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ELAS ACTINIC



------ ---- ---- ---- ------ ---- ---- ------ -------

** SUBJECT = 29

BASE 3.6 4.0 4.5 3.8 3.9 4.9 3.8

IMMED 3.0 3.5 4.2 4.0 3.7 5.0 3.6

WK-1 4.5 4.3 4.3 3.6 4.1 4.7 4.2

WK-4 3.7 3.7 3.8 3.2 3.5 3.9 3.7

WK-8 3.9 3.9 3.8 3.6 4.2 4.2 3.9

** SUBJECT = 30

BASE 3.6 2.9 4.7 3.1 3.9 5.0 3.1

IMMED 2.7 2.6 3.3 2.6 3.5 4.7 2.8

WK-1 5.2 4.0 5.0 2.4 3.7 4.9 3.6

WK-4 3.9 2.7 3.8 2.8 3.7 4.0 3.4

WK-8 3.0 2.8 2.1 2.9 3.2 3.0 2.9

** SUBJECT = 31

BASE 3.4 4.4 4.8 4.7 4.4 4.7 3.8

IMMED 2.7 4.1 3.7 3.9 3.7 4.1 3.5

WK-1 4.3 5.7 4.6 4.2 4.0 4.5 4.2

WK-4 4.0 4.6 4.4 3.7 4.0 4.2 3.1

WK-8 4.5 3.7 4.5 4.2 3.8 4.4 2.5

** SUBJECT = 32

BASE 3.2 4.6 4.7 4.2 3.7 4.8 4.2

IMMED 2.5 4.1 4.2 4.3 3.3 4.3 3.7

WK-1 4.4 5.5 5.0 4.7 4.0 5.0 4.2

WK-4 4.2 4.3 4.1 4.2 4.1 4.1 3.0

WK-8 2.8 4.2 3.3 4.0 3.6 4.2 2.3

** SUBJECT = 33

BASE 3.4 3.6 4.3 5.3 4.8 5.5 3.3 4.4

IMMED 2.6 3.3 3.2 5.3 3.7 5.1 3.1 3.9

WK-1 3.3 5.9 4.5 4.7 3.9 4.5 4.0 4.3

WK-4

WK-8 3.0 3.7 2.4 4.0 3.9 4.4 3.3 3.7

** SUBJECT = 35

BASE 2.9 3.5 4.9 3.2 3.5 5.1 4.7 4.5

IMMED 2.7 3.4 4.3 3.5 3.2 4.7 4.2 4.1

WK-1 4.6 3.7 4.7 3.3 3.8 4.8 4.9 5.1

WK-4 4.2 4.3 5.0 2.6 3.7 4.1 3.9 3.9

WK-8 3.5 3.8 4.2 2.6 3.5 3.5 3.7 3.1

** SUBJECT = 36

BASE 3.4 3.8 4.1 3.8 3.2 3.7 4.0 2.6

IMMED 3.0 3.5 3.6 4.1 3.6 3.2 3.4 2.6

WK-1 4.6 2.9 3.9 2.7 3.4 4.2 4.3 2.9

WK-4 4.2 3.7 3.8 2.6 3.6 4.2 4.4 2.8

WK-8 3.8 2.5 3.3 3.1 3.5 3.4 2.8 2.4

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SIASCOPE

HEMO- HEMO- HEMO- HEMO- AVG.

EVAL GLOBIN GLOBIN GLOBIN GLOBIN HEMO

TIME MEAN 1 SD 1 MEAN 2 SD 2 GLOBIN

------ ------ ------ ------ ------ ------

** SUBJECT = 01

BASE 488.24 292.75 505.98 303.92 497.11

WK-1 633.90 310.00 670.10 325.20 652.00

WK-4 179.90 18.70 172.70 20.90 176.30

WK-8 159.80 16.90 159.70 19.20 159.75

** SUBJECT = 02

BASE 588.17 352.73 485.58 287.81 536.88

WK-1 614.60 339.10 614.60 282.20 614.60

WK-4 158.80 15.80 164.10 15.50 161.45

WK-8 159.80 17.30 157.90 19.20 158.85

** SUBJECT = 03

BASE 494.49 304.50 499.44 293.43 496.97

WK-1 553.80 314.40 565.70 301.70 559.75

WK-4 149.70 14.60 140.60 14.50 145.15

WK-8 140.80 14.10 155.30 14.30 148.05

** SUBJECT = 04

BASE 386.04 320.53 502.66 265.50 444.35

WK-1 527.93 345.00 507.60 346.40 517.76

WK-4 209.20 34.10 208.70 24.10 208.95

WK-8 231.40 15.50 231.40 15.50 231.40

** SUBJECT = 05

BASE 449.41 284.35 459.22 279.65 454.32

WK-1 488.80 309.10 521.20 286.80 505.00

WK-4 163.20 18.40 160.90 19.40 162.05

WK-8 176.10 24.30 178.20 23.10 177.15

** SUBJECT = 06

BASE 409.05 448.98 277.75 283.28 343.40

WK-1 521.20 305.00 507.60 311.70 514.40

WK-4 187.70 22.30 183.50 21.60 185.60

WK-8 166.40 20.60 155.90 21.10 161.15

** SUBJECT = 07

BASE 472.49 276.54 520.41 278.50 496.45

WK-1 555.50 309.30 474.70 342.60 515.10

WK-4 171.80 13.70 167.70 15.50 169.75

WK-8 176.90 24.30 165.10 24.10 171.00

** SUBJECT = 08

BASE 559.37 312.92 496.35 271.95 527.86

WK-1 671.90 323.90 595.10 354.00 633.50

WK-4 160.40 19.60 144.50 19.50 152.45

WK-8 138.50 17.80 131.00 18.00 134.75

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SIASCOPE




------ ------ ------ ------ ------ ------

** SUBJECT = 09

BASE 404.60 311.43 407.25 321.50 405.93

WK-1 520.00 325.90 565.50 326.90 542.75

WK-4 138.30 14.10 120.10 12.10 129.20

WK-8 130.70 18.30 138.00 17.40 134.35

** SUBJECT = 10

BASE 552.46 312.29 449.38 308.34 500.92

WK-1 630.00 315.90 585.90 311.70 607.95

WK-4 152.80 15.90 147.50 13.10 150.15

WK-8 132.60 13.10 127.20 14.40 129.90

** SUBJECT = 12

BASE 468.09 331.51 405.47 311.40 436.78

WK-1 628.80 310.90 582.30 318.50 605.55

WK-4 136.70 15.70 130.00 12.70 133.35

WK-8 127.20 14.80 131.90 15.40 129.55

** SUBJECT = 13

BASE 496.72 297.04 544.52 295.99 520.62

WK-1 588.80 333.90 634.00 319.00 611.40

WK-4 154.90 16.50 122.40 14.50 138.65

WK-8 135.10 16.00 123.30 15.50 129.20

** SUBJECT = 14

BASE 428.17 307.88 469.03 340.26 448.60

WK-1 595.10 373.80 703.70 373.80 649.40

WK-4 167.20 17.80 145.00 15.90 156.10

WK-8 222.40 26.40 221.60 28.50 222.00

** SUBJECT = 15

BASE 473.22 317.97 397.57 291.02 435.39

WK-1 485.30 285.10 486.30 285.40 485.80

WK-4 158.40 15.20 164.90 16.80 161.65

WK-8 163.20 15.40 144.90 16.80 154.05

** SUBJECT = 16

BASE 447.74 364.39 367.93 275.03 407.84

WK-1 580.50 336.10 593.70 379.40 587.10

WK-4 200.50 21.40 175.10 23.70 187.80

WK-8 184.30 18.00 202.10 22.60 193.20

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SIASCOPE




------ ------ ------ ------ ------ ------

** SUBJECT = 18

BASE 450.22 263.10 471.11 269.85 460.67

WK-1 567.50 339.70 601.20 300.20 584.35

WK-4 163.40 15.00 170.20 17.50 166.80

WK-8 153.30 15.20 153.40 15.30 153.35

** SUBJECT = 19

BASE 433.00 274.71 419.41 288.51 426.21

WK-1 513.60 321.20 620.70 324.70 567.15

WK-4 158.40 17.20 140.70 14.90 149.55

WK-8 188.60 15.50 160.80 18.40 174.70

** SUBJECT = 20

BASE 457.97 286.35 498.93 284.81 478.45

WK-1 562.90 316.80 574.40 318.00 568.65

WK-4 151.10 18.10 151.30 15.40 151.20

WK-8 150.50 12.50 145.00 23.40 147.75

** SUBJECT = 21

BASE 493.25 298.67 555.61 315.52 524.43

WK-1 603.70 338.30 629.40 364.00 616.55

WK-4 185.70 17.90 209.20 28.50 197.45

WK-8 217.30 28.30 209.00 26.60 213.15

** SUBJECT = 22

BASE 459.52 296.96 434.26 285.34 446.89

WK-1 628.70 312.80 582.20 319.00 605.45

WK-4 151.30 15.50 161.80 16.40 156.55

WK-8 166.70 15.90 143.50 16.00 155.10

** SUBJECT = 23

BASE 466.94 269.12 486.94 280.72 476.94

WK-1 582.80 325.80 567.60 325.50 575.20

WK-4 178.80 17.20 176.00 17.30 177.40

WK-8 159.40 18.50 150.20 14.30 154.80

** SUBJECT = 24

BASE 524.64 299.39 398.51 303.94 461.57

WK-1 459.20 352.90 599.00 370.20 529.10

WK-4 215.40 30.50 202.80 32.30 209.10

WK-8 181.00 29.20 197.60 30.10 189.30

** SUBJECT = 25

BASE 494.84 304.45 464.02 316.44 479.43

WK-1 584.00 366.30 636.00 331.10 610.00

WK-4 215.00 29.50 210.40 31.60 212.70

WK-8 208.20 20.30 219.80 39.60 214.00

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SIASCOPE




------ ------ ------ ------ ------ ------

** SUBJECT = 26

BASE 491.14 287.53 492.00 316.13 491.57

WK-1 596.90 336.00 639.10 317.30 618.00

WK-4 151.10 18.90 169.10 21.10 160.10

WK-8 139.00 30.00 165.60 24.30 152.30

** SUBJECT = 27

BASE 504.14 282.54 459.53 264.34 481.83

WK-1 596.60 311.70 562.30 341.10 579.45

WK-4 177.50 22.00 172.10 18.70 174.80

WK-8 150.00 13.30 154.90 17.20 152.45

** SUBJECT = 28

BASE 368.20 352.56 386.89 326.47 377.54

WK-1 564.70 371.30 567.40 351.10 566.05

WK-4 199.50 19.40 195.20 19.30 197.35

WK-8 199.60 17.30 199.60 17.30 199.60

** SUBJECT = 29

BASE 481.55 281.50 485.51 301.78 483.53

WK-1 481.30 307.30 570.20 319.90 525.75

WK-4 162.80 16.70 176.00 16.40 169.40

WK-8 152.80 15.70 157.20 16.00 155.00

** SUBJECT = 30

BASE 515.71 351.08 455.94 343.83 485.83

WK-1 556.40 354.00 568.00 339.70 562.20

WK-4 200.90 21.80 183.30 23.50 192.10

WK-8 215.20 21.80 205.50 20.40 210.35

** SUBJECT = 31

BASE 472.31 287.95 458.46 280.81 465.38

WK-1 578.80 343.30 575.60 330.90 577.20

WK-4 138.50 14.30 136.40 14.30 137.45

WK-8 161.80 14.20 151.80 14.10 156.80

** SUBJECT = 32

BASE 558.01 296.28 473.24 285.85 515.62

WK-1 536.90 338.20 545.60 340.40 541.25

WK-4 181.20 18.90 175.50 18.40 178.35

WK-8 167.80 16.30 171.80 19.10 169.80

** SUBJECT = 33

BASE 507.32 335.02 539.37 326.24 523.35

WK-1 599.10 314.60 616.10 325.80 607.60

WK-4

WK-8 130.40 14.90 130.00 15.10 130.20

of 117

08/31/15.3



SIASCOPE




------ ------ ------ ------ ------ ------

** SUBJECT = 35

BASE 499.44 306.88 467.49 330.68 483.47

WK-1 711.90 225.10 699.70 223.90 705.80

WK-4 154.50 22.10 152.50 25.90 153.50

WK-8 133.30 20.40 128.80 14.60 131.05

** SUBJECT = 36

BASE 521.95 300.29 530.88 329.95 526.41

WK-1 241.40 18.10 275.60 23.50 258.50

WK-4 207.50 19.40 216.60 16.80 212.05

WK-8 188.50 14.00 192.30 15.40 190.40

of 117

08/31/15.3



QUESTIONNAIRE

EVAL

TIME Q1 Q2 Q3 Q4 Q5 Q6 Q7 Q8 Q9 Q10 Q11 Q12 Q13

------ -- -- -- -- -- -- -- -- -- --- --- --- ---

** SUBJECT = 01

IMMED 3 3 4 4 4 4 3 3 3 3 3 2 6

WK-1 3 3 2 2 3 2 2 3 3 3 2 2 6

WK-4 2 3 2 3 2 2 3 3 2 3 2 1 6

WK-8 2 3 2 3 2 2 2 3 2 3 2 1 6

** SUBJECT = 02

IMMED 3 2 2 2 2 2 3 3 3 3 2 2 3

WK-1 3 2 2 2 3 2 3 2 2 2 2 2 2

WK-4 2 2 2 2 2 2 2 2 2 2 2 2

WK-8 2 2 2 2 2 2 2 2 2 2 2 2

** SUBJECT = 03

IMMED 3 3 2 2 2 3 3 2 1 1 1 1 6

WK-1 3 3 2 2 4 3 3 3 1 2 1 1 6

WK-4 1 3 2 2 3 2 1 1 1 1 1 1 6

WK-8 3 2 2 2 2 2 1 1 1 2 1 1 6

** SUBJECT = 04

IMMED 3 2 2 2 3 2 3 3 2 2 2 1 6

WK-1 3 3 2 2 3 2 3 3 2 2 2 1 6

WK-4 3 3 2 2 3 2 3 3 2 2 2 1 6

WK-8 2 2 2 3 3 2 3 3 1 2 2 1 6

** SUBJECT = 05

IMMED 3 3 3 2 2 2 3 3 4 4 3 1 6

WK-1 4 2 2 2 2 2 4 4 4 4 4 2 6

WK-4 4 4 2 2 2 2 4 4 4 3 3 1 6

WK-8 4 2 2 2 2 2 4 4 3 3 3 1 6

** SUBJECT = 06

IMMED 3 3 2 2 2 2 3 3 2 2 2 3 6

WK-1 4 3 2 2 2 2 3 3 2 2 2 3 6

WK-4 3 3 5 2 2 2 3 3 2 2 2 2 6

WK-8 3 2 2 2 2 3 2 2 2 2 2 2 6

** SUBJECT = 07

IMMED 3 1 1 1 1 1 1 2 3 3 2 1 6

WK-1 2 2 2 2 2 2 2 2 3 3 2 1 6

WK-4 3 2 2 2 2 2 2 2 2 2 2 2 6

WK-8 2 2 1 2 1 1 1 1 2 2 2 1 6

** SUBJECT = 08

IMMED 3 3 2 2 2 2 3 3 3 3 3 3 6

WK-1 3 4 2 3 3 3 3 3 2 2 3 2 6

WK-4 3 3 2 3 3 3 2 2 2 2 2 2 6

WK-8 3 4 4 3 3 3 3 3 2 2 3 3 6

of 117

08/31/15.3



QUESTIONNAIRE

EVAL


------ -- -- -- -- -- -- -- -- -- --- --- --- ---

** SUBJECT = 09

IMMED 2 3 3 2 3 2 2 3 2 2 2 2 2

WK-1 3 2 2 3 3 3 3 3 2 2 2 2 2

WK-4 3 3 2 3 2 3 3 3 2 2 2 2 2

WK-8 2 3 3 3 3 2 3 3 2 2 2 2 3

** SUBJECT = 10

IMMED 3 3 2 2 2 2 3 3 3 3 3 1 6

WK-1 3 2 2 2 2 2 3 3 3 3 3 1 6

WK-4 3 3 2 3 3 2 3 3 3 3 3 2 6

WK-8 3 2 2 3 3 2 3 3 2 3 3 2 6

** SUBJECT = 12

IMMED 2 2 1 1 1 1 3 3 2 2 2 1 6

WK-1 1 2 1 1 1 1 2 1 1 2 1 1 6

WK-4 1 1 1 1 2 1 1 2 1 2 1 1 6

WK-8 1 1 1 2 1 1 2 2 2 1 1 1 6

** SUBJECT = 13

IMMED 1 3 1 1 1 1 1 1 2 1 1 1 6

WK-1 1 2 1 1 1 1 1 1 1 1 1 1 6

WK-4 1 1 1 1 1 1 1 1 1 1 1 1 6

WK-8 1 2 1 1 1 1 1 1 1 1 1 1 6

** SUBJECT = 14

IMMED 3 3 3 3 3 3 3 3 3 3 3 3 3

WK-1 3 3 3 3 3 3 3 3 3 3 3 2 3

WK-4 3 3 3 3 3 3 3 3 3 3 3 3 3

WK-8 3 3 3 3 3 3 3 3 3 3 3 3 3

** SUBJECT = 15

IMMED 3 3 3 3 3 3 3 3 3 3 3 3 3

WK-1 3 3 3 3 3 3 3 3 3 3 3 3 3

WK-4 3 3 3 3 3 3 3 3 3 3 3 3 3

WK-8 3 3 3 3 3 3 3 3 3 3 3 3 3

** SUBJECT = 16

IMMED 3 3 2 2 2 2 3 3 2 2 2 1 6

WK-1 2 2 2 2 2 2 2 2 2 2 2 1 6

WK-4 1 1 1 1 1 1 1 1 1 1 1 1 6

WK-8 1 1 1 1 1 1 1 1 1 1 1 1 6

of 117

08/31/15.3



QUESTIONNAIRE

EVAL


------ -- -- -- -- -- -- -- -- -- --- --- --- ---

** SUBJECT = 18

IMMED 3 2 2 2 2 2 2 2 2 2 2 2 2

WK-1 3 3 2 2 2 2 2 2 2 2 2 2 2

WK-4 2 2 2 2 2 2 2 2 2 2 2 1 2

WK-8 2 2 2 2 2 2 2 2 2 2 2 1 4

** SUBJECT = 19

IMMED 3 2 2 2 3 3 3 3 3 3 3 1 6

WK-1 2 2 2 2 2 2 2 2 2 2 2 1 6

WK-4 2 2 2 2 2 2 2 2 1 1 1 1 6

WK-8 1 1 1 1 1 1 1 1 1 1 1 1 6

** SUBJECT = 20

IMMED 3 2 2 2 2 3 3 3 2 2 2 1 6

WK-1 2 3 2 2 2 3 2 2 2 2 2 1 6

WK-4 3 2 2 2 3 2 3 3 2 2 2 2 6

WK-8 2 2 2 2 3 2 2 2 2 2 2 2 6

** SUBJECT = 21

IMMED 3 3 3 3 3 3 3 3 3 3 3 1 6

WK-1 2 3 2 2 2 2 2 2 2 2 2 1 6

WK-4 2 3 3 3 3 3 2 2 2 3 2 2 6

WK-8 2 3 2 2 3 2 2 2 2 2 2 1 6

** SUBJECT = 22

IMMED 2 2 2 2 2 2 2 2 2 2 2 2 6

WK-1 2 2 2 2 2 2 2 2 2 2 2 2 6

WK-4 2 2 2 1 1 1 2 2 2 2 2 1 6

WK-8 1 1 1 1 2 1 2 1 2 2 2 1 6

** SUBJECT = 23

IMMED 3 3 1 1 2 2 3 3 2 2 3 1 1

WK-1 2 2 1 1 1 1 2 2 1 1 1 1 1

WK-4 1 1 1 1 1 1 1 1 1 1 1 1 1

WK-8 1 2 1 1 1 1 1 2 1 1 1 1 1

** SUBJECT = 24

IMMED 5 5 5 5 5 5 5 5 5 5 5 5 6

WK-1 5 5 5 5 5 5 5 5 5 5 5 2 6

WK-4 4 4 4 4 4 4 4 4 4 4 4 4 6

WK-8 4 4 4 4 4 4 4 4 4 4 4 2 6

** SUBJECT = 25

IMMED 2 3 2 3 3 2 3 3 2 3 3 2 3

WK-1 2 3 3 3 3 2 2 2 3 3 3 1 2

WK-4 2 3 3 2 2 2 3 3 3 3 2 2 3

WK-8 2 3 2 2 3 2 3 3 2 2 2 2 2

of 117

08/31/15.3



QUESTIONNAIRE

EVAL


------ -- -- -- -- -- -- -- -- -- --- --- --- ---

** SUBJECT = 26

IMMED 3 3 3 3 3 3 3 3 3 3 3 3 6

WK-1 2 3 3 3 2 3 3 3 2 2 2 2 6

WK-4 4 2 3 2 3 3 3 2 2 3 3 2 6

WK-8 3 2 2 2 2 3 3 3 1 1 2 1 6

** SUBJECT = 27

IMMED 2 2 3 2 2 2 2 3 2 2 2 2 2

WK-1 2 2 2 2 2 3 2 2 2 2 2 1 1

WK-4 2 2 3 2 3 3 3 2 2 2 2 2 2

WK-8 1 2 1 2 2 1 2 2 1 1 1 1 1

** SUBJECT = 28

IMMED 3 3 3 3 3 3 3 3 3 3 3 2 3

WK-1 3 3 3 3 3 3 3 3 2 3 3 2 3

WK-4 3 3 2 2 3 2 3 3 2 2 2 2 3

WK-8 3 2 2 2 3 2 3 3 2 2 2 1 2

** SUBJECT = 29

IMMED 3 3 3 3 3 2 3 3 3 3 3 2 6

WK-1 3 3 3 3 3 3 3 3 2 2 2 2 6

WK-4 3 2 2 2 3 2 3 3 2 2 2 2 6

WK-8 3 2 2 2 3 2 3 3 2 2 2 1 6

** SUBJECT = 30

IMMED 3 3 3 2 3 2 3 3 2 2 2 2 3

WK-1 3 3 3 3 3 3 3 3 2 2 2 2 3

WK-4 3 3 2 2 3 3 3 3 2 2 2 2 3

WK-8 2 3 2 2 3 3 2 3 2 2 2 2 3

** SUBJECT = 31

IMMED 5 5 3 3 3 2 5 5 2 3 4 4 6

WK-1 3 3 3 3 3 3 3 3 3 3 3 2 6

WK-4 3 3 3 2 3 2 3 3 3 3 2 2 6

WK-8 3 3 2 2 3 2 3 3 3 3 3 1 6

** SUBJECT = 32

IMMED 3 3 3 2 3 2 3 3 3 3 3 2 3

WK-1 3 3 2 3 3 2 3 3 3 3 3 2 3

WK-4 3 3 2 2 2 2 3 3 3 3 2 1 2

WK-8 3 3 2 3 2 2 2 2 3 3 2 2 2

** SUBJECT = 33

IMMED 3 3 2 3 3 2 3 3 2 3 3 1 3

WK-1 2 3 2 2 3 3 3 3 3 3 3 1 3

WK-4

WK-8 2 3 3 3 2 3 3 3 2 3 2 1 3

of 117

08/31/15.3



QUESTIONNAIRE

EVAL


------ -- -- -- -- -- -- -- -- -- --- --- --- ---

** SUBJECT = 35

IMMED 4 4 3 3 3 2 4 4 4 4 4 3 4

WK-1 4 4 3 4 4 3 4 4 3 4 4 1 4

WK-4 4 4 4 4 4 4 4 4 3 3 3 1 4

WK-8 3 4 3 3 3 2 3 3 2 2 3 1 3

** SUBJECT = 36

IMMED 3 3 3 3 3 3 3 3 2 2 2 3 3

WK-1 3 3 2 2 3 2 2 2 2 2 2 1 1

WK-4 2 3 2 2 2 2 3 2 2 2 2 3 3

WK-8 1 3 1 2 2 2 2 2 1 2 2 1 2

of 117

IRSI - SKIN CONDITION STUDY #3931OSM0415 8/25/15.1

MEDICAL HISTORY

HGT SUBJECTS HEIGHT

Valid Cum

Value Label Value Frequency Percent Percent Percent

59.0 1 3.0 3.0 3.0

60.0 3 9.1 9.1 12.1

61.0 2 6.1 6.1 18.2

62.0 2 6.1 6.1 24.2

63.0 5 15.2 15.2 39.4

63.5 1 3.0 3.0 42.4

64.0 5 15.2 15.2 57.6

64.5 1 3.0 3.0 60.6

65.0 4 12.1 12.1 72.7

66.0 1 3.0 3.0 75.8

67.0 3 9.1 9.1 84.8

68.0 2 6.1 6.1 90.9

69.0 3 9.1 9.1 100.0

------- ------- -------

TOTAL 33 100.0 100.0

Mean 64.182 Std Err .482 Median 64.000

Std Dev 2.769 Variance 7.669

Valid Cases 33 Missing Cases 0

of 117


MEDICAL HISTORY

WGT SUBJECTS WEIGHT

Valid Cum


96 1 3.0 3.0 3.0

103 2 6.1 6.1 9.1

112 1 3.0 3.0 12.1

130 3 9.1 9.1 21.2

135 1 3.0 3.0 24.2

140 2 6.1 6.1 30.3

148 1 3.0 3.0 33.3

150 4 12.1 12.1 45.5

160 1 3.0 3.0 48.5

165 1 3.0 3.0 51.5

169 1 3.0 3.0 54.5

170 1 3.0 3.0 57.6

173 1 3.0 3.0 60.6

178 1 3.0 3.0 63.6

180 1 3.0 3.0 66.7

190 3 9.1 9.1 75.8

200 4 12.1 12.1 87.9

216 1 3.0 3.0 90.9

220 1 3.0 3.0 93.9

240 1 3.0 3.0 97.0

300 1 3.0 3.0 100.0

------- ------- -------

TOTAL 33 100.0 100.0

Mean 166.909 Std Err 7.470 Median 165.000



of 117


MEDICAL HISTORY

AGE SUBJECTS AGE

Valid Cum


35 1 3.0 3.0 3.0

37 1 3.0 3.0 6.1

38 1 3.0 3.0 9.1

43 1 3.0 3.0 12.1

45 1 3.0 3.0 15.2

46 1 3.0 3.0 18.2

47 1 3.0 3.0 21.2

48 3 9.1 9.1 30.3

49 4 12.1 12.1 42.4

50 1 3.0 3.0 45.5

52 3 9.1 9.1 54.5

54 1 3.0 3.0 57.6

55 1 3.0 3.0 60.6

56 2 6.1 6.1 66.7

57 2 6.1 6.1 72.7

58 4 12.1 12.1 84.8

59 4 12.1 12.1 97.0

60 1 3.0 3.0 100.0

------- ------- -------

TOTAL 33 100.0 100.0

Mean 51.515 Std Err 1.184 Median 52.000



- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

ETHN SUBJECTS ETHNICITY

Valid Cum


HISPANIC 1.00 6 18.2 18.2 18.2

NON-HISPANIC 2.00 27 81.8 81.8 100.0

------- ------- -------

TOTAL 33 100.0 100.0


of 117


MEDICAL HISTORY

RACE SUBJECTS RACE

Valid Cum


WHITE 1.00 27 81.8 96.4 96.4

BLACK 2.00 1 3.0 3.6 100.0

. 5 15.2 MISSING

------- ------- -------

TOTAL 33 100.0 100.0


- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

FACE SUBJECTS FACIAL SKIN

Valid Cum


DRY 1.00 3 9.1 9.1 9.1

OILY 2.00 1 3.0 3.0 12.1

NORMAL 3.00 14 42.4 42.4 54.5

COMBO 4.00 15 45.5 45.5 100.0

------- ------- -------

TOTAL 33 100.0 100.0


- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

BODY SUBJECTS BODY SKIN

Valid Cum


NORMAL 1.00 25 75.8 75.8 75.8

DRY 2.00 8 24.2 24.2 100.0

------- ------- -------

TOTAL 33 100.0 100.0


of 117


MEDICAL HISTORY

FITZ SUBJECTS FITZPATRICK SCORE

Valid Cum


1 1 3.0 3.0 3.0

2 10 30.3 30.3 33.3

3 15 45.5 45.5 78.8

4 6 18.2 18.2 97.0

5 1 3.0 3.0 100.0

------- ------- -------

TOTAL 33 100.0 100.0


Std Dev .857 Variance .735


- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

SKIN SUBJECT HAS SENSITIVE SKIN

Valid Cum


YES 1.00 4 12.1 12.1 12.1

NO 2.00 29 87.9 87.9 100.0

------- ------- -------

TOTAL 33 100.0 100.0


- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

EYES SUBJECT HAS SENSITIVE EYES

Valid Cum


YES 1.00 5 15.2 15.2 15.2

NO 2.00 28 84.8 84.8 100.0

------- ------- -------

TOTAL 33 100.0 100.0


of 117


MEDICAL HISTORY

LENS SUBJECT WEARS CONTACTS

Valid Cum


YES 1.00 6 18.2 18.2 18.2

NO 2.00 27 81.8 81.8 100.0

------- ------- -------

TOTAL 33 100.0 100.0


- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

OCCU SUBJECTS OCCUPATION

Valid Cum


RETIRED 2.00 5 15.2 15.2 15.2

HOMEMAKER 3.00 10 30.3 30.3 45.5

UNEMPLOYED 4.00 5 15.2 15.2 60.6

EMPLOYED 5.00 13 39.4 39.4 100.0

------- ------- -------

TOTAL 33 100.0 100.0


of 117


VISUALS/SIASCOPE

Paired samples t-test: TEXT0 BASE TEXTURE/SMOOTHNESS

TEXT1 IMMED TEXTURE/SMOOTHNESS

Variable Number Standard Standard

of Cases Mean Deviation Error

TEXT0 33 4.0515 .491 .086

TEXT1 33 3.0788 .550 .096

(Difference) Standard Standard | 2-Tail | t Degrees of 2-Tail

Mean Deviation Error | Corr. Prob. | Value Freedom Prob.

| |

.9727 .526 .092 | .495 .003 | 10.63 32 .000


TEXT2 WK-1 TEXTURE/SMOOTHNESS



TEXT0 33 4.0515 .491 .086

TEXT2 33 4.2727 .446 .078



| |

-.2212 .676 .118 | -.039 .829 | -1.88 32 .069





TEXT0 32 4.0719 .485 .086

TEXT4 32 4.1219 .276 .049



| |

-.0500 .502 .089 | .220 .227 | -.56 31 .577

of 117


VISUALS/SIASCOPE





TEXT0 33 4.0515 .491 .086

TEXT8 33 3.5939 .490 .085



| |

.4576 .639 .111 | .153 .395 | 4.11 32 .000

Paired samples t-test: LINE0 BASE FINE LINES (CROWS FEET)

LINE1 IMMED FINE LINES (CROWS FEET)



LINE0 33 4.2000 .860 .150

LINE1 33 3.7152 .776 .135



| |

.4848 .203 .035 | .974 .000 | 13.70 32 .000


LINE2 WK-1 FINE LINES (CROWS FEET)



LINE0 33 4.2000 .860 .150

LINE2 33 4.6697 .982 .171



| |

-.4697 .803 .140 | .627 .000 | -3.36 32 .002

of 117


VISUALS/SIASCOPE





LINE0 32 4.2188 .867 .153

LINE4 32 4.0031 .824 .146



| |

.2156 .655 .116 | .701 .000 | 1.86 31 .072





LINE0 33 4.2000 .860 .150

LINE8 33 3.4818 .783 .136



| |

.7182 .622 .108 | .717 .000 | 6.64 32 .000

Paired samples t-test: RADI0 BASE RADIANCE

RADI1 IMMED RADIANCE



RADI0 33 4.7303 .423 .074

RADI1 33 3.2000 .598 .104



| |

1.5303 .810 .141 | -.235 .189 | 10.86 32 .000

of 117


VISUALS/SIASCOPE


RADI2 WK-1 RADIANCE



RADI0 33 4.7303 .423 .074

RADI2 33 4.6636 .578 .101



| |

.0667 .469 .082 | .600 .000 | .82 32 .420


RADI4 WK-4 RADIANCE



RADI0 32 4.7437 .423 .075

RADI4 32 4.2094 .386 .068



| |

.5344 .431 .076 | .435 .013 | 7.02 31 .000


RADI8 WK-8 RADIANCE



RADI0 33 4.7303 .423 .074

RADI8 33 3.2030 .727 .127



| |

1.5273 .765 .133 | .199 .267 | 11.47 32 .000

of 117


VISUALS/SIASCOPE

Paired samples t-test: LAXI0 BASE EYELID LAXITY

LAXI1 IMMED EYELID LAXITY



LAXI0 33 3.8606 .905 .158

LAXI1 33 3.6697 .853 .149



| |

.1909 .285 .050 | .949 .000 | 3.84 32 .001


LAXI2 WK-1 EYELID LAXITY



LAXI0 33 3.8606 .905 .158

LAXI2 33 3.7818 .797 .139



| |

.0788 .766 .133 | .601 .000 | .59 32 .559





LAXI0 32 3.8156 .881 .156

LAXI4 32 3.5000 .590 .104



| |

.3156 .645 .114 | .681 .000 | 2.77 31 .009

of 117


VISUALS/SIASCOPE





LAXI0 33 3.8606 .905 .158

LAXI8 33 3.2333 .610 .106



| |

.6273 .643 .112 | .704 .000 | 5.61 32 .000

Paired samples t-test: ELAS0 BASE ELASTICITY

ELAS1 IMMED ELASTICITY



ELAS0 33 3.9061 .362 .063

ELAS1 33 3.4667 .359 .063



| |

.4394 .335 .058 | .568 .001 | 7.53 32 .000


ELAS2 WK-1 ELASTICITY



ELAS0 33 3.9061 .362 .063

ELAS2 33 3.8939 .376 .065



| |

.0121 .397 .069 | .420 .015 | .18 32 .862

of 117


VISUALS/SIASCOPE





ELAS0 32 3.8781 .330 .058

ELAS4 32 3.9750 .278 .049



| |

-.0969 .374 .066 | .254 .161 | -1.47 31 .153





ELAS0 33 3.9061 .362 .063

ELAS8 33 3.5061 .352 .061



| |

.4000 .405 .070 | .358 .041 | 5.68 32 .000

Paired samples t-test: OVER0 BASE OVERALL APPEARANCE

OVER1 IMMED OVERALL APPEARANCE



OVER0 33 4.8091 .386 .067

OVER1 33 4.2576 .575 .100



| |

.5515 .451 .078 | .623 .000 | 7.03 32 .000

of 117


VISUALS/SIASCOPE


OVER2 WK-1 OVERALL APPEARANCE



OVER0 33 4.8091 .386 .067

OVER2 33 4.6152 .355 .062



| |

.1939 .390 .068 | .447 .009 | 2.85 32 .008





OVER0 32 4.7875 .371 .066

OVER4 32 4.3375 .350 .062



| |

.4500 .461 .081 | .185 .311 | 5.53 31 .000





OVER0 33 4.8091 .386 .067

OVER8 33 3.8030 .516 .090



| |

1.0061 .430 .075 | .579 .000 | 13.44 32 .000

of 117


VISUALS/SIASCOPE

Paired samples t-test: CAPL0 BASE CAPILLARY VISIBILITY

CAPL1 IMMED CAPILLARY VISIBILITY



CAPL0 19 4.3895 .681 .156

CAPL1 19 4.1474 .711 .163



| |

.2421 .257 .059 | .933 .000 | 4.11 18 .001


CAPL2 WK-1 CAPILLARY VISIBILITY



CAPL0 19 4.3895 .681 .156

CAPL2 19 4.3789 .654 .150



| |

.0105 .386 .088 | .834 .000 | .12 18 .907





CAPL0 18 4.4500 .646 .152

CAPL4 18 3.9278 .573 .135



| |

.5222 .467 .110 | .712 .001 | 4.74 17 .000

of 117


VISUALS/SIASCOPE





CAPL0 19 4.3895 .681 .156

CAPL8 19 3.2632 .618 .142



| |

1.1263 .558 .128 | .635 .004 | 8.80 18 .000

Paired samples t-test: ACTN0 BASE ACTINIC KERATOSIS SEVERITY

ACTN1 IMMED ACTINIC KERATOSIS SEVERITY



ACTN0 14 3.5929 .664 .177

ACTN1 14 3.2857 .589 .158



| |

.3071 .169 .045 | .971 .000 | 6.82 13 .000


ACTN2 WK-1 ACTINIC KERATOSIS SEVERITY



ACTN0 14 3.5929 .664 .177

ACTN2 14 3.8000 .660 .176



| |

-.2071 .693 .185 | .451 .105 | -1.12 13 .284

of 117


VISUALS/SIASCOPE





ACTN0 13 3.5308 .647 .180

ACTN4 13 3.3462 .425 .118



| |

.1846 .552 .153 | .536 .059 | 1.21 12 .251





ACTN0 14 3.5929 .664 .177

ACTN8 14 2.9571 .520 .139



| |

.6357 .714 .191 | .291 .313 | 3.33 13 .005

Paired samples t-test: HEMO0 BASE SIASCOPE - HEMOGLOBIN

HEMO2 WK-1 SIASCOPE - HEMOGLOBIN



HEMO0 33 470.9861 45.003 7.834

HEMO2 33 569.7064 73.715 12.832



| |

-98.7203 83.157 14.476 | .082 .650 | -6.82 32 .000

of 117


VISUALS/SIASCOPE





HEMO0 32 469.3497 44.715 7.905

HEMO4 32 169.2016 23.730 4.195



| |

300.1481 51.138 9.040 | -.025 .893 | 33.20 31 .000





HEMO0 33 470.9861 45.003 7.834

HEMO8 33 166.1955 29.322 5.104



| |

304.7906 57.905 10.080 | -.177 .324 | 30.24 32 .000

of 117


ITEXT1 IMPRV IMMED TEXTURE/SMOOTHNESS

Valid Cum


IMPROVED 1.00 32 97.0 97.0 97.0

SAME 2.00 1 3.0 3.0 100.0

------- ------- -------

TOTAL 33 100.0 100.0


- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

ILINE1 IMPRV IMMED FINE LINES (CROWS FEET)

Valid Cum


IMPROVED 1.00 33 100.0 100.0 100.0

------- ------- -------

TOTAL 33 100.0 100.0


- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

IRADI1 IMPRV IMMED RADIANCE

Valid Cum


IMPROVED 1.00 31 93.9 93.9 93.9

SAME 2.00 2 6.1 6.1 100.0

------- ------- -------

TOTAL 33 100.0 100.0


- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

ILAXI1 IMPRV IMMED EYELID LAXITY

Valid Cum


IMPROVED 1.00 24 72.7 72.7 72.7

SAME 2.00 3 9.1 9.1 81.8

WORSE 3.00 6 18.2 18.2 100.0

------- ------- -------

TOTAL 33 100.0 100.0


of 117


IELAS1 IMPRV IMMED ELASTICITY

Valid Cum


IMPROVED 1.00 31 93.9 93.9 93.9

SAME 2.00 1 3.0 3.0 97.0

WORSE 3.00 1 3.0 3.0 100.0

------- ------- -------

TOTAL 33 100.0 100.0


- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

IOVER1 IMPRV IMMED OVERALL APPEARANCE

Valid Cum


IMPROVED 1.00 28 84.8 84.8 84.8

SAME 2.00 1 3.0 3.0 87.9

WORSE 3.00 4 12.1 12.1 100.0

------- ------- -------

TOTAL 33 100.0 100.0


- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

ICAPL1 IMPRV IMMED CAPILLARY VISIBILITY

Valid Cum


IMPROVED 1.00 15 45.5 78.9 78.9

WORSE 3.00 4 12.1 21.1 100.0

. 14 42.4 MISSING

------- ------- -------

TOTAL 33 100.0 100.0


- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

IACTN1 IMPRV IMMED ACTINIC KERATOSIS SEVERITY

Valid Cum


IMPROVED 1.00 13 39.4 92.9 92.9

SAME 2.00 1 3.0 7.1 100.0

. 19 57.6 MISSING

------- ------- -------

TOTAL 33 100.0 100.0


of 117


ITEXT2 IMPRV WK-1 TEXTURE/SMOOTHNESS

Valid Cum


IMPROVED 1.00 14 42.4 42.4 42.4

SAME 2.00 1 3.0 3.0 45.5

WORSE 3.00 18 54.5 54.5 100.0

------- ------- -------

TOTAL 33 100.0 100.0


- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

ILINE2 IMPRV WK-1 FINE LINES (CROWS FEET)

Valid Cum


IMPROVED 1.00 6 18.2 18.2 18.2

SAME 2.00 2 6.1 6.1 24.2

WORSE 3.00 25 75.8 75.8 100.0

------- ------- -------

TOTAL 33 100.0 100.0


- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

IRADI2 IMPRV WK-1 RADIANCE

Valid Cum


IMPROVED 1.00 19 57.6 57.6 57.6

SAME 2.00 1 3.0 3.0 60.6

WORSE 3.00 13 39.4 39.4 100.0

------- ------- -------

TOTAL 33 100.0 100.0


- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

ILAXI2 IMPRV WK-1 EYELID LAXITY

Valid Cum


IMPROVED 1.00 17 51.5 51.5 51.5

WORSE 3.00 16 48.5 48.5 100.0

------- ------- -------

TOTAL 33 100.0 100.0


of 117


IELAS2 IMPRV WK-1 ELASTICITY

Valid Cum


IMPROVED 1.00 13 39.4 39.4 39.4

SAME 2.00 4 12.1 12.1 51.5

WORSE 3.00 16 48.5 48.5 100.0

------- ------- -------

TOTAL 33 100.0 100.0


- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

IOVER2 IMPRV WK-1 OVERALL APPEARANCE

Valid Cum


IMPROVED 1.00 23 69.7 69.7 69.7

SAME 2.00 1 3.0 3.0 72.7

WORSE 3.00 9 27.3 27.3 100.0

------- ------- -------

TOTAL 33 100.0 100.0


- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

ICAPL2 IMPRV WK-1 CAPILLARY VISIBILITY

Valid Cum


IMPROVED 1.00 8 24.2 42.1 42.1

SAME 2.00 3 9.1 15.8 57.9

WORSE 3.00 8 24.2 42.1 100.0

. 14 42.4 MISSING

------- ------- -------

TOTAL 33 100.0 100.0


of 117


IACTN2 IMPRV WK-1 ACTINIC KERATOSIS SEVERITY

Valid Cum


IMPROVED 1.00 5 15.2 35.7 35.7

SAME 2.00 1 3.0 7.1 42.9

WORSE 3.00 8 24.2 57.1 100.0

. 19 57.6 MISSING

------- ------- -------

TOTAL 33 100.0 100.0


- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

IHEMO2 IMPRV WK-1 SIASCOPE - HEMOGLOBIN

Valid Cum


IMPROVED 1.00 1 3.0 3.0 3.0

WORSE 3.00 32 97.0 97.0 100.0

------- ------- -------

TOTAL 33 100.0 100.0


- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -


Valid Cum


IMPROVED 1.00 19 57.6 59.4 59.4

WORSE 3.00 13 39.4 40.6 100.0

. 1 3.0 MISSING

------- ------- -------

TOTAL 33 100.0 100.0


of 117



Valid Cum


IMPROVED 1.00 20 60.6 62.5 62.5

SAME 2.00 2 6.1 6.3 68.8

WORSE 3.00 10 30.3 31.3 100.0

. 1 3.0 MISSING

------- ------- -------

TOTAL 33 100.0 100.0


- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -


Valid Cum


IMPROVED 1.00 27 81.8 84.4 84.4

SAME 2.00 1 3.0 3.1 87.5

WORSE 3.00 4 12.1 12.5 100.0

. 1 3.0 MISSING

------- ------- -------

TOTAL 33 100.0 100.0


- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -


Valid Cum


IMPROVED 1.00 19 57.6 59.4 59.4

SAME 2.00 3 9.1 9.4 68.8

WORSE 3.00 10 30.3 31.3 100.0

. 1 3.0 MISSING

------- ------- -------

TOTAL 33 100.0 100.0


of 117



Valid Cum


IMPROVED 1.00 10 30.3 31.3 31.3

SAME 2.00 4 12.1 12.5 43.8

WORSE 3.00 18 54.5 56.3 100.0

. 1 3.0 MISSING

------- ------- -------

TOTAL 33 100.0 100.0


- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -


Valid Cum


IMPROVED 1.00 27 81.8 84.4 84.4

SAME 2.00 1 3.0 3.1 87.5

WORSE 3.00 4 12.1 12.5 100.0

. 1 3.0 MISSING

------- ------- -------

TOTAL 33 100.0 100.0


- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -


Valid Cum


IMPROVED 1.00 16 48.5 88.9 88.9

SAME 2.00 1 3.0 5.6 94.4

WORSE 3.00 1 3.0 5.6 100.0

. 15 45.5 MISSING

------- ------- -------

TOTAL 33 100.0 100.0


of 117



Valid Cum


IMPROVED 1.00 7 21.2 53.8 53.8

WORSE 3.00 6 18.2 46.2 100.0

. 20 60.6 MISSING

------- ------- -------

TOTAL 33 100.0 100.0


- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -


Valid Cum


WORSE 3.00 32 97.0 100.0 100.0

. 1 3.0 MISSING

------- ------- -------

TOTAL 33 100.0 100.0


- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -


Valid Cum


IMPROVED 1.00 25 75.8 75.8 75.8

SAME 2.00 1 3.0 3.0 78.8

WORSE 3.00 7 21.2 21.2 100.0

------- ------- -------

TOTAL 33 100.0 100.0


- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -


Valid Cum


IMPROVED 1.00 29 87.9 87.9 87.9

SAME 2.00 1 3.0 3.0 90.9

WORSE 3.00 3 9.1 9.1 100.0

------- ------- -------

TOTAL 33 100.0 100.0


of 117



Valid Cum


IMPROVED 1.00 33 100.0 100.0 100.0

------- ------- -------

TOTAL 33 100.0 100.0


- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -


Valid Cum


IMPROVED 1.00 27 81.8 81.8 81.8

SAME 2.00 2 6.1 6.1 87.9

WORSE 3.00 4 12.1 12.1 100.0

------- ------- -------

TOTAL 33 100.0 100.0


- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -


Valid Cum


IMPROVED 1.00 25 75.8 75.8 75.8

SAME 2.00 4 12.1 12.1 87.9

WORSE 3.00 4 12.1 12.1 100.0

------- ------- -------

TOTAL 33 100.0 100.0


- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -


Valid Cum


IMPROVED 1.00 33 100.0 100.0 100.0

------- ------- -------

TOTAL 33 100.0 100.0


of 117



Valid Cum


IMPROVED 1.00 17 51.5 89.5 89.5

SAME 2.00 1 3.0 5.3 94.7

WORSE 3.00 1 3.0 5.3 100.0

. 14 42.4 MISSING

------- ------- -------

TOTAL 33 100.0 100.0


- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -


Valid Cum


IMPROVED 1.00 13 39.4 92.9 92.9

WORSE 3.00 1 3.0 7.1 100.0

. 19 57.6 MISSING

------- ------- -------

TOTAL 33 100.0 100.0


- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -


Valid Cum


WORSE 3.00 33 100.0 100.0 100.0

------- ------- -------

TOTAL 33 100.0 100.0


of 117


VISUALS/SIASCOPE

Number of Valid Observations (Listwise) = 5.00

Variable TEXT0 BASE TEXTURE/SMOOTHNESS

Mean 4.052 S.E. Mean .086


Kurtosis -.439 S.E. Kurt .798

Skewness -.443 S.E. Skew .409

Range 2.000 Minimum 2.9

Maximum 4.9 Sum 133.700

Valid Observations - 33 Missing Observations - 0

- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

Variable LINE0 BASE FINE LINES (CROWS FEET)



Kurtosis .657 S.E. Kurt .798

Skewness .202 S.E. Skew .409




- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

Variable RADI0 BASE RADIANCE








- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

Variable LAXI0 BASE EYELID LAXITY



Kurtosis -1.230 S.E. Kurt .798





of 117


VISUALS/SIASCOPE


Variable ELAS0 BASE ELASTICITY








- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

Variable OVER0 BASE OVERALL APPEARANCE



Kurtosis 2.146 S.E. Kurt .798

Skewness -1.306 S.E. Skew .409




- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

Variable CAPL0 BASE CAPILLARY VISIBILITY



Kurtosis -.691 S.E. Kurt 1.014





- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

Variable ACTN0 BASE ACTINIC KERATOSIS SEVERITY



Kurtosis -1.334 S.E. Kurt 1.154





of 117


VISUALS/SIASCOPE


Variable HEMO0 BASE SIASCOPE - HEMOGLOBIN

Mean 470.986 S.E. Mean 7.834





Maximum 536.88 Sum 15542.540


- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

Variable TEXT1 IMMED TEXTURE/SMOOTHNESS








- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

Variable LINE1 IMMED FINE LINES (CROWS FEET)








- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

Variable RADI1 IMMED RADIANCE








of 117


VISUALS/SIASCOPE


Variable LAXI1 IMMED EYELID LAXITY








- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

Variable ELAS1 IMMED ELASTICITY








- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

Variable OVER1 IMMED OVERALL APPEARANCE








- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

Variable CAPL1 IMMED CAPILLARY VISIBILITY








of 117


VISUALS/SIASCOPE


Variable ACTN1 IMMED ACTINIC KERATOSIS SEVERITY








- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

Variable TEXT2 WK-1 TEXTURE/SMOOTHNESS








- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

Variable LINE2 WK-1 FINE LINES (CROWS FEET)








- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

Variable RADI2 WK-1 RADIANCE








of 117


VISUALS/SIASCOPE


Variable LAXI2 WK-1 EYELID LAXITY








- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

Variable ELAS2 WK-1 ELASTICITY








- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

Variable OVER2 WK-1 OVERALL APPEARANCE








- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

Variable CAPL2 WK-1 CAPILLARY VISIBILITY








of 117


VISUALS/SIASCOPE


Variable ACTN2 WK-1 ACTINIC KERATOSIS SEVERITY








- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

Variable HEMO2 WK-1 SIASCOPE - HEMOGLOBIN

Mean 569.706 S.E. Mean 12.832





Maximum 705.80 Sum 18800.310


- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -









- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -









of 117


VISUALS/SIASCOPE










- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -









- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -









- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -









of 117


VISUALS/SIASCOPE










- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -









- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -


Mean 169.202 S.E. Mean 4.195





Maximum 212.70 Sum 5414.450


- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -









of 117


VISUALS/SIASCOPE










- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -









- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -









- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -









of 117


VISUALS/SIASCOPE










- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -









- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -









- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -


Mean 166.195 S.E. Mean 5.104





Maximum 231.40 Sum 5484.450


of 117


VISUALS/SIASCOPE


Variable DTEXT1 DIFF IMMED TEXTURE/SMOOTHNESS

Mean -.973 S.E. Mean .092




Range 2.100 Minimum -2.10

Maximum .00 Sum -32.100


- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

Variable DLINE1 DIFF IMMED FINE LINES (CROWS FEET)





Range .700 Minimum -.80

Maximum -.10 Sum -16.000


- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

Variable DRADI1 DIFF IMMED RADIANCE

Mean -1.530 S.E. Mean .141







- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

Variable DLAXI1 DIFF IMMED EYELID LAXITY





Range 1.200 Minimum -.80



of 117


VISUALS/SIASCOPE


Variable DELAS1 DIFF IMMED ELASTICITY








- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

Variable DOVER1 DIFF IMMED OVERALL APPEARANCE








- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

Variable DCAPL1 DIFF IMMED CAPILLARY VISIBILITY



Kurtosis 1.156 S.E. Kurt 1.014





- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

Variable DACTN1 DIFF IMMED ACTINIC KERATOSIS SEVERITY





Range .500 Minimum -.50



of 117


VISUALS/SIASCOPE


Variable DTEXT2 DIFF WK-1 TEXTURE/SMOOTHNESS

Mean .221 S.E. Mean .118







- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

Variable DLINE2 DIFF WK-1 FINE LINES (CROWS FEET)








- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

Variable DRADI2 DIFF WK-1 RADIANCE






Maximum 1.20 Sum -2.200


- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

Variable DLAXI2 DIFF WK-1 EYELID LAXITY








of 117


VISUALS/SIASCOPE


Variable DELAS2 DIFF WK-1 ELASTICITY






Maximum .70 Sum -.400


- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

Variable DOVER2 DIFF WK-1 OVERALL APPEARANCE








- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

Variable DCAPL2 DIFF WK-1 CAPILLARY VISIBILITY






Maximum .70 Sum -.200


- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

Variable DACTN2 DIFF WK-1 ACTINIC KERATOSIS SEVERITY








of 117


VISUALS/SIASCOPE


Variable DHEMO2 DIFF WK-1 SIASCOPE - HEMOGLOBIN

Mean 98.720 S.E. Mean 14.476





Maximum 222.33 Sum 3257.770


- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -









- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -









- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -









of 117


VISUALS/SIASCOPE










- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -







Maximum .90 Sum 3.100


- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -









- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -









of 117


VISUALS/SIASCOPE










- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -


Mean -300.148 S.E. Mean 9.040





Maximum -157.80 Sum -9604.740


- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -









- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -









of 117


VISUALS/SIASCOPE



Mean -1.527 S.E. Mean .133







- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -









- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -









- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -


Mean -1.006 S.E. Mean .075







of 117


VISUALS/SIASCOPE



Mean -1.126 S.E. Mean .128


Kurtosis .680 S.E. Kurt 1.014





- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -









- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -


Mean -304.791 S.E. Mean 10.080





Maximum -177.94 Sum -10058.090


- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

Variable PTEXT1 % CHG IMMED TEXTURE/SMOOTHNESS

Mean -23.662 S.E. Mean 2.024







of 117


VISUALS/SIASCOPE


Variable PLINE1 % CHG IMMED FINE LINES (CROWS FEET)

Mean -11.471 S.E. Mean .778





Maximum -2.86 Sum -378.538


- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

Variable PRADI1 % CHG IMMED RADIANCE

Mean -31.521 S.E. Mean 2.723







- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

Variable PLAXI1 % CHG IMMED EYELID LAXITY

Mean -4.594 S.E. Mean 1.431





Maximum 17.39 Sum -151.606


- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

Variable PELAS1 % CHG IMMED ELASTICITY

Mean -10.981 S.E. Mean 1.473





Maximum 12.50 Sum -362.376


of 117


VISUALS/SIASCOPE


Variable POVER1 % CHG IMMED OVERALL APPEARANCE

Mean -11.486 S.E. Mean 1.664







- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

Variable PCAPL1 % CHG IMMED CAPILLARY VISIBILITY

Mean -5.565 S.E. Mean 1.353







- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

Variable PACTN1 % CHG IMMED ACTINIC KERATOSIS SEVERITY

Mean -8.371 S.E. Mean 1.207







- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

Variable PTEXT2 % CHG WK-1 TEXTURE/SMOOTHNESS

Mean 7.196 S.E. Mean 3.295







of 117


VISUALS/SIASCOPE


Variable PLINE2 % CHG WK-1 FINE LINES (CROWS FEET)

Mean 12.965 S.E. Mean 3.952







- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

Variable PRADI2 % CHG WK-1 RADIANCE

Mean -1.282 S.E. Mean 1.754







- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

Variable PLAXI2 % CHG WK-1 EYELID LAXITY

Mean .901 S.E. Mean 3.857







- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

Variable PELAS2 % CHG WK-1 ELASTICITY








of 117


VISUALS/SIASCOPE


Variable POVER2 % CHG WK-1 OVERALL APPEARANCE

Mean -3.637 S.E. Mean 1.488





Maximum 21.05 Sum -120.030


- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

Variable PCAPL2 % CHG WK-1 CAPILLARY VISIBILITY








- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

Variable PACTN2 % CHG WK-1 ACTINIC KERATOSIS SEVERITY

Mean 8.072 S.E. Mean 6.183



Skewness 1.622 S.E. Skew .597




- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

Variable PHEMO2 % CHG WK-1 SIASCOPE - HEMOGLOBIN

Mean 21.993 S.E. Mean 3.183







of 117


VISUALS/SIASCOPE



Mean 2.606 S.E. Mean 2.491







- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -


Mean -3.803 S.E. Mean 2.932





Maximum 46.15 Sum -121.710


- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -


Mean -10.840 S.E. Mean 1.591





Maximum 10.81 Sum -346.867


- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -


Mean -5.522 S.E. Mean 3.150





Maximum 41.67 Sum -176.707


of 117


VISUALS/SIASCOPE



Mean 3.048 S.E. Mean 1.719







- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -


Mean -8.897 S.E. Mean 1.742





Maximum 13.51 Sum -284.706


- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -


Mean -11.299 S.E. Mean 2.254





Maximum 10.00 Sum -203.385


- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -


Mean -3.291 S.E. Mean 4.219







of 117


VISUALS/SIASCOPE



Mean -63.569 S.E. Mean 1.190





Maximum -45.95 Sum -2034.212


- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -


Mean -10.139 S.E. Mean 2.780





Maximum 32.35 Sum -334.589


- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -


Mean -16.676 S.E. Mean 2.454







- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -


Mean -32.006 S.E. Mean 2.700





Maximum -2.44 Sum -1056.195


of 117


VISUALS/SIASCOPE



Mean -14.088 S.E. Mean 2.538





Maximum 19.23 Sum -464.912


- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -


Mean -9.804 S.E. Mean 1.733







- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -


Mean -20.910 S.E. Mean 1.586





Maximum -6.38 Sum -690.025


- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -


Mean -25.193 S.E. Mean 2.871







of 117


VISUALS/SIASCOPE



Mean -15.499 S.E. Mean 5.313





Maximum 38.46 Sum -216.990


- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -


Mean -64.259 S.E. Mean 1.372





Maximum -47.13 Sum -2120.535


of 117


QUESTIONNAIRE -IMMEDIATE-

AQ01 IMMED Q01 REDUCED CAPILLARY REDNESS

Valid Cum


STRONG AGREE 1 1 3.0 3.0 3.0

AGREE 2 5 15.2 15.2 18.2

NEUTRAL 3 24 72.7 72.7 90.9

DISAGREE 4 1 3.0 3.0 93.9

STRONG DISAGREE 5 2 6.1 6.1 100.0

------- ------- -------

TOTAL 33 100.0 100.0




- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

AQ02 IMMED Q02 IMPROVED EYELID LAXITY

Valid Cum


STRONG AGREE 1 1 3.0 3.0 3.0

AGREE 2 8 24.2 24.2 27.3

NEUTRAL 3 21 63.6 63.6 90.9

DISAGREE 4 1 3.0 3.0 93.9


------- ------- -------

TOTAL 33 100.0 100.0




of 117



AQ03 IMMED Q03 IMPROVED FACIAL FIRMNESS

Valid Cum


STRONG AGREE 1 4 12.1 12.1 12.1

AGREE 2 13 39.4 39.4 51.5

NEUTRAL 3 14 42.4 42.4 93.9

DISAGREE 4 1 3.0 3.0 97.0


------- ------- -------

TOTAL 33 100.0 100.0




- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

AQ04 IMMED Q04 IMPROVED FACIAL ELASTICITY

Valid Cum


STRONG AGREE 1 4 12.1 12.1 12.1

AGREE 2 16 48.5 48.5 60.6

NEUTRAL 3 11 33.3 33.3 93.9

DISAGREE 4 1 3.0 3.0 97.0


------- ------- -------

TOTAL 33 100.0 100.0




of 117



AQ05 IMMED Q05 LIFTED FACIAL SKIN

Valid Cum


STRONG AGREE 1 3 9.1 9.1 9.1

AGREE 2 12 36.4 36.4 45.5

NEUTRAL 3 16 48.5 48.5 93.9

DISAGREE 4 1 3.0 3.0 97.0


------- ------- -------

TOTAL 33 100.0 100.0




- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

AQ06 IMMED Q06 TIGHTENED FACIAL SKIN

Valid Cum


STRONG AGREE 1 3 9.1 9.1 9.1

AGREE 2 19 57.6 57.6 66.7

NEUTRAL 3 9 27.3 27.3 93.9

DISAGREE 4 1 3.0 3.0 97.0


------- ------- -------

TOTAL 33 100.0 100.0




of 117



AQ07 IMMED Q07 IMPROVED LINES/WRINKLES

Valid Cum


STRONG AGREE 1 2 6.1 6.1 6.1

AGREE 2 4 12.1 12.1 18.2

NEUTRAL 3 24 72.7 72.7 90.9

DISAGREE 4 1 3.0 3.0 93.9


------- ------- -------

TOTAL 33 100.0 100.0




- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

AQ08 IMMED Q08 REDUCED LINES/WRINKLES

Valid Cum


STRONG AGREE 1 1 3.0 3.0 3.0

AGREE 2 4 12.1 12.1 15.2

NEUTRAL 3 25 75.8 75.8 90.9

DISAGREE 4 1 3.0 3.0 93.9


------- ------- -------

TOTAL 33 100.0 100.0




of 117



AQ09 IMMED Q09 FACIAL SKIN MORE RADIANT

Valid Cum


STRONG AGREE 1 1 3.0 3.0 3.0

AGREE 2 16 48.5 48.5 51.5

NEUTRAL 3 13 39.4 39.4 90.9

DISAGREE 4 2 6.1 6.1 97.0


------- ------- -------

TOTAL 33 100.0 100.0




- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

AQ10 IMMED Q10 FRESH YOUTH INFUSED GLOW

Valid Cum


STRONG AGREE 1 2 6.1 6.1 6.1

AGREE 2 12 36.4 36.4 42.4

NEUTRAL 3 16 48.5 48.5 90.9

DISAGREE 4 2 6.1 6.1 97.0


------- ------- -------

TOTAL 33 100.0 100.0




of 117



AQ11 IMMED Q11 ENHANCED OVERALL APPEARANCE

Valid Cum


STRONG AGREE 1 2 6.1 6.1 6.1

AGREE 2 13 39.4 39.4 45.5

NEUTRAL 3 15 45.5 45.5 90.9

DISAGREE 4 2 6.1 6.1 97.0


------- ------- -------

TOTAL 33 100.0 100.0




- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

AQ12 IMMED Q12 DID NOT EXPERIENCE IRRITATION

Valid Cum


STRONG AGREE 1 13 39.4 39.4 39.4

AGREE 2 11 33.3 33.3 72.7

NEUTRAL 3 7 21.2 21.2 93.9

DISAGREE 4 1 3.0 3.0 97.0


------- ------- -------

TOTAL 33 100.0 100.0




of 117



AQ13 IMMED Q13 RELIEF OF ACTINIC KERTOSIS

Valid Cum


STRONG AGREE 1 1 3.0 6.7 6.7

AGREE 2 3 9.1 20.0 26.7

NEUTRAL 3 9 27.3 60.0 86.7

DISAGREE 4 2 6.1 13.3 100.0

NOT APPLICABLE 6 18 54.5 MISSING

------- ------- -------

TOTAL 33 100.0 100.0




of 117



XAQ01 IMMED Q01 REDUCED CAPILLARY REDNESS

Valid Cum


POSITIVE 1-2 1.00 6 18.2 18.2 18.2

NEUT/NEGATIVE 2.00 27 81.8 81.8 100.0

------- ------- -------

TOTAL 33 100.0 100.0


- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

XAQ02 IMMED Q02 IMPROVED EYELID LAXITY

Valid Cum


POSITIVE 1-2 1.00 9 27.3 27.3 27.3

NEUT/NEGATIVE 2.00 24 72.7 72.7 100.0

------- ------- -------

TOTAL 33 100.0 100.0


- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

XAQ03 IMMED Q03 IMPROVED FACIAL FIRMNESS

Valid Cum


POSITIVE 1-2 1.00 17 51.5 51.5 51.5

NEUT/NEGATIVE 2.00 16 48.5 48.5 100.0

------- ------- -------

TOTAL 33 100.0 100.0


- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

XAQ04 IMMED Q04 IMPROVED FACIAL ELASTICITY

Valid Cum


POSITIVE 1-2 1.00 20 60.6 60.6 60.6

NEUT/NEGATIVE 2.00 13 39.4 39.4 100.0

------- ------- -------

TOTAL 33 100.0 100.0


of 117



XAQ05 IMMED Q05 LIFTED FACIAL SKIN

Valid Cum


POSITIVE 1-2 1.00 15 45.5 45.5 45.5

NEUT/NEGATIVE 2.00 18 54.5 54.5 100.0

------- ------- -------

TOTAL 33 100.0 100.0


- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

XAQ06 IMMED Q06 TIGHTENED FACIAL SKIN

Valid Cum


POSITIVE 1-2 1.00 22 66.7 66.7 66.7

NEUT/NEGATIVE 2.00 11 33.3 33.3 100.0

------- ------- -------

TOTAL 33 100.0 100.0


- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

XAQ07 IMMED Q07 IMPROVED LINES/WRINKLES

Valid Cum


POSITIVE 1-2 1.00 6 18.2 18.2 18.2

NEUT/NEGATIVE 2.00 27 81.8 81.8 100.0

------- ------- -------

TOTAL 33 100.0 100.0


- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

XAQ08 IMMED Q08 REDUCED LINES/WRINKLES

Valid Cum


POSITIVE 1-2 1.00 5 15.2 15.2 15.2

NEUT/NEGATIVE 2.00 28 84.8 84.8 100.0

------- ------- -------

TOTAL 33 100.0 100.0


of 117



XAQ09 IMMED Q09 FACIAL SKIN MORE RADIANT

Valid Cum


POSITIVE 1-2 1.00 17 51.5 51.5 51.5

NEUT/NEGATIVE 2.00 16 48.5 48.5 100.0

------- ------- -------

TOTAL 33 100.0 100.0


- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

XAQ10 IMMED Q10 FRESH YOUTH INFUSED GLOW

Valid Cum


POSITIVE 1-2 1.00 14 42.4 42.4 42.4

NEUT/NEGATIVE 2.00 19 57.6 57.6 100.0

------- ------- -------

TOTAL 33 100.0 100.0


- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

XAQ11 IMMED Q11 ENHANCED OVERALL APPEARANCE

Valid Cum


POSITIVE 1-2 1.00 15 45.5 45.5 45.5

NEUT/NEGATIVE 2.00 18 54.5 54.5 100.0

------- ------- -------

TOTAL 33 100.0 100.0


- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

XAQ12 IMMED Q12 DID NOT EXPERIENCE IRRITATION

Valid Cum


POSITIVE 1-2 1.00 24 72.7 72.7 72.7

NEUT/NEGATIVE 2.00 9 27.3 27.3 100.0

------- ------- -------

TOTAL 33 100.0 100.0


of 117



XAQ13 IMMED Q13 RELIEF OF ACTINIC KERTOSIS

Valid Cum


POSITIVE 1-2 1.00 4 12.1 26.7 26.7

NEUT/NEGATIVE 2.00 11 33.3 73.3 100.0

. 18 54.5 MISSING

------- ------- -------

TOTAL 33 100.0 100.0


of 117


QUESTIONNAIRE -WEEK 1-

BQ01 WK-1 Q01 REDUCED CAPILLARY REDNESS

Valid Cum


STRONG AGREE 1 2 6.1 6.1 6.1

AGREE 2 11 33.3 33.3 39.4

NEUTRAL 3 16 48.5 48.5 87.9

DISAGREE 4 3 9.1 9.1 97.0


------- ------- -------

TOTAL 33 100.0 100.0




- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

BQ02 WK-1 Q02 IMPROVED EYELID LAXITY

Valid Cum


AGREE 2 12 36.4 36.4 36.4

NEUTRAL 3 18 54.5 54.5 90.9

DISAGREE 4 2 6.1 6.1 97.0


------- ------- -------

TOTAL 33 100.0 100.0




of 117



BQ03 WK-1 Q03 IMPROVED FACIAL FIRMNESS

Valid Cum


STRONG AGREE 1 3 9.1 9.1 9.1

AGREE 2 20 60.6 60.6 69.7

NEUTRAL 3 9 27.3 27.3 97.0


------- ------- -------

TOTAL 33 100.0 100.0




- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

BQ04 WK-1 Q04 IMPROVED FACIAL ELASTICITY

Valid Cum


STRONG AGREE 1 3 9.1 9.1 9.1

AGREE 2 17 51.5 51.5 60.6

NEUTRAL 3 11 33.3 33.3 93.9

DISAGREE 4 1 3.0 3.0 97.0


------- ------- -------

TOTAL 33 100.0 100.0




of 117



BQ05 WK-1 Q05 LIFTED FACIAL SKIN

Valid Cum


STRONG AGREE 1 3 9.1 9.1 9.1

AGREE 2 12 36.4 36.4 45.5

NEUTRAL 3 15 45.5 45.5 90.9

DISAGREE 4 2 6.1 6.1 97.0


------- ------- -------

TOTAL 33 100.0 100.0




- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

BQ06 WK-1 Q06 TIGHTENED FACIAL SKIN

Valid Cum


STRONG AGREE 1 3 9.1 9.1 9.1

AGREE 2 15 45.5 45.5 54.5

NEUTRAL 3 14 42.4 42.4 97.0


------- ------- -------

TOTAL 33 100.0 100.0




of 117



BQ07 WK-1 Q07 IMPROVED LINES/WRINKLES

Valid Cum


STRONG AGREE 1 1 3.0 3.0 3.0

AGREE 2 13 39.4 39.4 42.4

NEUTRAL 3 16 48.5 48.5 90.9

DISAGREE 4 2 6.1 6.1 97.0


------- ------- -------

TOTAL 33 100.0 100.0




- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

BQ08 WK-1 Q08 REDUCED LINES/WRINKLES

Valid Cum


STRONG AGREE 1 2 6.1 6.1 6.1

AGREE 2 12 36.4 36.4 42.4

NEUTRAL 3 16 48.5 48.5 90.9

DISAGREE 4 2 6.1 6.1 97.0


------- ------- -------

TOTAL 33 100.0 100.0




of 117



BQ09 WK-1 Q09 FACIAL SKIN MORE RADIANT

Valid Cum


STRONG AGREE 1 4 12.1 12.1 12.1

AGREE 2 17 51.5 51.5 63.6

NEUTRAL 3 10 30.3 30.3 93.9

DISAGREE 4 1 3.0 3.0 97.0


------- ------- -------

TOTAL 33 100.0 100.0




- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

BQ10 WK-1 Q10 FRESH YOUTH INFUSED GLOW

Valid Cum


STRONG AGREE 1 2 6.1 6.1 6.1

AGREE 2 18 54.5 54.5 60.6

NEUTRAL 3 10 30.3 30.3 90.9

DISAGREE 4 2 6.1 6.1 97.0


------- ------- -------

TOTAL 33 100.0 100.0




of 117



BQ11 WK-1 Q11 ENHANCED OVERALL APPEARANCE

Valid Cum


STRONG AGREE 1 4 12.1 12.1 12.1

AGREE 2 17 51.5 51.5 63.6

NEUTRAL 3 9 27.3 27.3 90.9

DISAGREE 4 2 6.1 6.1 97.0


------- ------- -------

TOTAL 33 100.0 100.0




- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

BQ12 WK-1 Q12 DID NOT EXPERIENCE IRRITATION

Valid Cum


STRONG AGREE 1 16 48.5 48.5 48.5

AGREE 2 15 45.5 45.5 93.9

NEUTRAL 3 2 6.1 6.1 100.0

------- ------- -------

TOTAL 33 100.0 100.0




of 117



BQ13 WK-1 Q13 RELIEF OF ACTINIC KERTOSIS

Valid Cum


STRONG AGREE 1 3 9.1 21.4 21.4

AGREE 2 4 12.1 28.6 50.0

NEUTRAL 3 6 18.2 42.9 92.9

DISAGREE 4 1 3.0 7.1 100.0


------- ------- -------

TOTAL 33 100.0 100.0




of 117



XBQ01 WK-1 Q01 REDUCED CAPILLARY REDNESS

Valid Cum


POSITIVE 1-2 1.00 13 39.4 39.4 39.4

NEUT/NEGATIVE 2.00 20 60.6 60.6 100.0

------- ------- -------

TOTAL 33 100.0 100.0


- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

XBQ02 WK-1 Q02 IMPROVED EYELID LAXITY

Valid Cum


POSITIVE 1-2 1.00 12 36.4 36.4 36.4

NEUT/NEGATIVE 2.00 21 63.6 63.6 100.0

------- ------- -------

TOTAL 33 100.0 100.0


- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

XBQ03 WK-1 Q03 IMPROVED FACIAL FIRMNESS

Valid Cum


POSITIVE 1-2 1.00 23 69.7 69.7 69.7

NEUT/NEGATIVE 2.00 10 30.3 30.3 100.0

------- ------- -------

TOTAL 33 100.0 100.0


- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

XBQ04 WK-1 Q04 IMPROVED FACIAL ELASTICITY

Valid Cum


POSITIVE 1-2 1.00 20 60.6 60.6 60.6

NEUT/NEGATIVE 2.00 13 39.4 39.4 100.0

------- ------- -------

TOTAL 33 100.0 100.0


of 117



XBQ05 WK-1 Q05 LIFTED FACIAL SKIN

Valid Cum


POSITIVE 1-2 1.00 15 45.5 45.5 45.5

NEUT/NEGATIVE 2.00 18 54.5 54.5 100.0

------- ------- -------

TOTAL 33 100.0 100.0


- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

XBQ06 WK-1 Q06 TIGHTENED FACIAL SKIN

Valid Cum


POSITIVE 1-2 1.00 18 54.5 54.5 54.5

NEUT/NEGATIVE 2.00 15 45.5 45.5 100.0

------- ------- -------

TOTAL 33 100.0 100.0


- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

XBQ07 WK-1 Q07 IMPROVED LINES/WRINKLES

Valid Cum


POSITIVE 1-2 1.00 14 42.4 42.4 42.4

NEUT/NEGATIVE 2.00 19 57.6 57.6 100.0

------- ------- -------

TOTAL 33 100.0 100.0


- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

XBQ08 WK-1 Q08 REDUCED LINES/WRINKLES

Valid Cum


POSITIVE 1-2 1.00 14 42.4 42.4 42.4

NEUT/NEGATIVE 2.00 19 57.6 57.6 100.0

------- ------- -------

TOTAL 33 100.0 100.0


of 117



XBQ09 WK-1 Q09 FACIAL SKIN MORE RADIANT

Valid Cum


POSITIVE 1-2 1.00 21 63.6 63.6 63.6

NEUT/NEGATIVE 2.00 12 36.4 36.4 100.0

------- ------- -------

TOTAL 33 100.0 100.0


- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

XBQ10 WK-1 Q10 FRESH YOUTH INFUSED GLOW

Valid Cum


POSITIVE 1-2 1.00 20 60.6 60.6 60.6

NEUT/NEGATIVE 2.00 13 39.4 39.4 100.0

------- ------- -------

TOTAL 33 100.0 100.0


- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

XBQ11 WK-1 Q11 ENHANCED OVERALL APPEARANCE

Valid Cum


POSITIVE 1-2 1.00 21 63.6 63.6 63.6

NEUT/NEGATIVE 2.00 12 36.4 36.4 100.0

------- ------- -------

TOTAL 33 100.0 100.0


- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

XBQ12 WK-1 Q12 DID NOT EXPERIENCE IRRITATION

Valid Cum


POSITIVE 1-2 1.00 31 93.9 93.9 93.9

NEUT/NEGATIVE 2.00 2 6.1 6.1 100.0

------- ------- -------

TOTAL 33 100.0 100.0


of 117



XBQ13 WK-1 Q13 RELIEF OF ACTINIC KERTOSIS

Valid Cum


POSITIVE 1-2 1.00 7 21.2 50.0 50.0

NEUT/NEGATIVE 2.00 7 21.2 50.0 100.0

. 19 57.6 MISSING

------- ------- -------

TOTAL 33 100.0 100.0


of 117



CQ01 WK-4 Q01 REDUCED CAPILLARY REDNESS

Valid Cum


STRONG AGREE 1 5 15.2 15.6 15.6

AGREE 2 9 27.3 28.1 43.8

NEUTRAL 3 14 42.4 43.8 87.5

DISAGREE 4 4 12.1 12.5 100.0

. 1 3.0 MISSING

------- ------- -------

TOTAL 33 100.0 100.0




- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

CQ02 WK-4 Q02 IMPROVED EYELID LAXITY

Valid Cum


STRONG AGREE 1 4 12.1 12.5 12.5

AGREE 2 9 27.3 28.1 40.6

NEUTRAL 3 16 48.5 50.0 90.6

DISAGREE 4 3 9.1 9.4 100.0

. 1 3.0 MISSING

------- ------- -------

TOTAL 33 100.0 100.0




of 117



CQ03 WK-4 Q03 IMPROVED FACIAL FIRMNESS

Valid Cum


STRONG AGREE 1 4 12.1 12.5 12.5

AGREE 2 18 54.5 56.3 68.8

NEUTRAL 3 7 21.2 21.9 90.6

DISAGREE 4 2 6.1 6.3 96.9


. 1 3.0 MISSING

------- ------- -------

TOTAL 33 100.0 100.0




- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

CQ04 WK-4 Q04 IMPROVED FACIAL ELASTICITY

Valid Cum


STRONG AGREE 1 5 15.2 15.6 15.6

AGREE 2 18 54.5 56.3 71.9

NEUTRAL 3 7 21.2 21.9 93.8

DISAGREE 4 2 6.1 6.3 100.0

. 1 3.0 MISSING

------- ------- -------

TOTAL 33 100.0 100.0




of 117



CQ05 WK-4 Q05 LIFTED FACIAL SKIN

Valid Cum


STRONG AGREE 1 4 12.1 12.5 12.5

AGREE 2 12 36.4 37.5 50.0

NEUTRAL 3 14 42.4 43.8 93.8

DISAGREE 4 2 6.1 6.3 100.0

. 1 3.0 MISSING

------- ------- -------

TOTAL 33 100.0 100.0




- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

CQ06 WK-4 Q06 TIGHTENED FACIAL SKIN

Valid Cum


STRONG AGREE 1 5 15.2 15.6 15.6

AGREE 2 17 51.5 53.1 68.8

NEUTRAL 3 8 24.2 25.0 93.8

DISAGREE 4 2 6.1 6.3 100.0

. 1 3.0 MISSING

------- ------- -------

TOTAL 33 100.0 100.0




of 117



CQ07 WK-4 Q07 IMPROVED LINES/WRINKLES

Valid Cum


STRONG AGREE 1 5 15.2 15.6 15.6

AGREE 2 7 21.2 21.9 37.5

NEUTRAL 3 17 51.5 53.1 90.6

DISAGREE 4 3 9.1 9.4 100.0

. 1 3.0 MISSING

------- ------- -------

TOTAL 33 100.0 100.0




- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

CQ08 WK-4 Q08 REDUCED LINES/WRINKLES

Valid Cum


STRONG AGREE 1 4 12.1 12.5 12.5

AGREE 2 11 33.3 34.4 46.9

NEUTRAL 3 14 42.4 43.8 90.6

DISAGREE 4 3 9.1 9.4 100.0

. 1 3.0 MISSING

------- ------- -------

TOTAL 33 100.0 100.0




of 117



CQ09 WK-4 Q09 FACIAL SKIN MORE RADIANT

Valid Cum


STRONG AGREE 1 6 18.2 18.8 18.8

AGREE 2 17 51.5 53.1 71.9

NEUTRAL 3 7 21.2 21.9 93.8

DISAGREE 4 2 6.1 6.3 100.0

. 1 3.0 MISSING

------- ------- -------

TOTAL 33 100.0 100.0




- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

CQ10 WK-4 Q10 FRESH YOUTH INFUSED GLOW

Valid Cum


STRONG AGREE 1 5 15.2 15.6 15.6

AGREE 2 15 45.5 46.9 62.5

NEUTRAL 3 11 33.3 34.4 96.9

DISAGREE 4 1 3.0 3.1 100.0

. 1 3.0 MISSING

------- ------- -------

TOTAL 33 100.0 100.0




of 117



CQ11 WK-4 Q11 ENHANCED OVERALL APPEARANCE

Valid Cum


STRONG AGREE 1 6 18.2 18.8 18.8

AGREE 2 19 57.6 59.4 78.1

NEUTRAL 3 6 18.2 18.8 96.9

DISAGREE 4 1 3.0 3.1 100.0

. 1 3.0 MISSING

------- ------- -------

TOTAL 33 100.0 100.0




- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

CQ12 WK-4 Q12 DID NOT EXPERIENCE IRRITATION

Valid Cum


STRONG AGREE 1 13 39.4 40.6 40.6

AGREE 2 15 45.5 46.9 87.5

NEUTRAL 3 3 9.1 9.4 96.9

DISAGREE 4 1 3.0 3.1 100.0

. 1 3.0 MISSING

------- ------- -------

TOTAL 33 100.0 100.0




of 117



CQ13 WK-4 Q13 RELIEF OF ACTINIC KERTOSIS

Valid Cum


STRONG AGREE 1 1 3.0 8.3 8.3

AGREE 2 4 12.1 33.3 41.7

NEUTRAL 3 6 18.2 50.0 91.7

DISAGREE 4 1 3.0 8.3 100.0

. 2 6.1 MISSING


------- ------- -------

TOTAL 33 100.0 100.0




of 117



XCQ01 WK-4 Q01 REDUCED CAPILLARY REDNESS

Valid Cum


POSITIVE 1-2 1.00 14 42.4 43.8 43.8

NEUT/NEGATIVE 2.00 18 54.5 56.3 100.0

. 1 3.0 MISSING

------- ------- -------

TOTAL 33 100.0 100.0


- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

XCQ02 WK-4 Q02 IMPROVED EYELID LAXITY

Valid Cum


POSITIVE 1-2 1.00 13 39.4 40.6 40.6

NEUT/NEGATIVE 2.00 19 57.6 59.4 100.0

. 1 3.0 MISSING

------- ------- -------

TOTAL 33 100.0 100.0


- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

XCQ03 WK-4 Q03 IMPROVED FACIAL FIRMNESS

Valid Cum


POSITIVE 1-2 1.00 22 66.7 68.8 68.8

NEUT/NEGATIVE 2.00 10 30.3 31.3 100.0

. 1 3.0 MISSING

------- ------- -------

TOTAL 33 100.0 100.0


- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

XCQ04 WK-4 Q04 IMPROVED FACIAL ELASTICITY

Valid Cum


POSITIVE 1-2 1.00 23 69.7 71.9 71.9

NEUT/NEGATIVE 2.00 9 27.3 28.1 100.0

. 1 3.0 MISSING

------- ------- -------

TOTAL 33 100.0 100.0

of 117


of 117



XCQ05 WK-4 Q05 LIFTED FACIAL SKIN

Valid Cum


POSITIVE 1-2 1.00 16 48.5 50.0 50.0

NEUT/NEGATIVE 2.00 16 48.5 50.0 100.0

. 1 3.0 MISSING

------- ------- -------

TOTAL 33 100.0 100.0


- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

XCQ06 WK-4 Q06 TIGHTENED FACIAL SKIN

Valid Cum


POSITIVE 1-2 1.00 22 66.7 68.8 68.8

NEUT/NEGATIVE 2.00 10 30.3 31.3 100.0

. 1 3.0 MISSING

------- ------- -------

TOTAL 33 100.0 100.0


- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

XCQ07 WK-4 Q07 IMPROVED LINES/WRINKLES

Valid Cum


POSITIVE 1-2 1.00 12 36.4 37.5 37.5

NEUT/NEGATIVE 2.00 20 60.6 62.5 100.0

. 1 3.0 MISSING

------- ------- -------

TOTAL 33 100.0 100.0


- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

XCQ08 WK-4 Q08 REDUCED LINES/WRINKLES

Valid Cum


POSITIVE 1-2 1.00 15 45.5 46.9 46.9

NEUT/NEGATIVE 2.00 17 51.5 53.1 100.0

. 1 3.0 MISSING

------- ------- -------

TOTAL 33 100.0 100.0


of 117



XCQ09 WK-4 Q09 FACIAL SKIN MORE RADIANT

Valid Cum


POSITIVE 1-2 1.00 23 69.7 71.9 71.9

NEUT/NEGATIVE 2.00 9 27.3 28.1 100.0

. 1 3.0 MISSING

------- ------- -------

TOTAL 33 100.0 100.0


- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

XCQ10 WK-4 Q10 FRESH YOUTH INFUSED GLOW

Valid Cum


POSITIVE 1-2 1.00 20 60.6 62.5 62.5

NEUT/NEGATIVE 2.00 12 36.4 37.5 100.0

. 1 3.0 MISSING

------- ------- -------

TOTAL 33 100.0 100.0


- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

XCQ11 WK-4 Q11 ENHANCED OVERALL APPEARANCE

Valid Cum


POSITIVE 1-2 1.00 25 75.8 78.1 78.1

NEUT/NEGATIVE 2.00 7 21.2 21.9 100.0

. 1 3.0 MISSING

------- ------- -------

TOTAL 33 100.0 100.0


- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

XCQ12 WK-4 Q12 DID NOT EXPERIENCE IRRITATION

Valid Cum


POSITIVE 1-2 1.00 28 84.8 87.5 87.5

NEUT/NEGATIVE 2.00 4 12.1 12.5 100.0

. 1 3.0 MISSING

------- ------- -------

TOTAL 33 100.0 100.0


of 117



XCQ13 WK-4 Q13 RELIEF OF ACTINIC KERTOSIS

Valid Cum


POSITIVE 1-2 1.00 5 15.2 41.7 41.7

NEUT/NEGATIVE 2.00 7 21.2 58.3 100.0

. 21 63.6 MISSING

------- ------- -------

TOTAL 33 100.0 100.0


of 117



DQ01 WK-8 Q01 REDUCED CAPILLARY REDNESS

Valid Cum


STRONG AGREE 1 8 24.2 24.2 24.2

AGREE 2 11 33.3 33.3 57.6

NEUTRAL 3 12 36.4 36.4 93.9

DISAGREE 4 2 6.1 6.1 100.0

------- ------- -------

TOTAL 33 100.0 100.0




- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

DQ02 WK-8 Q02 IMPROVED EYELID LAXITY

Valid Cum


STRONG AGREE 1 4 12.1 12.1 12.1

AGREE 2 15 45.5 45.5 57.6

NEUTRAL 3 11 33.3 33.3 90.9

DISAGREE 4 3 9.1 9.1 100.0

------- ------- -------

TOTAL 33 100.0 100.0




- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

DQ03 WK-8 Q03 IMPROVED FACIAL FIRMNESS

Valid Cum


STRONG AGREE 1 9 27.3 27.3 27.3

AGREE 2 17 51.5 51.5 78.8

NEUTRAL 3 5 15.2 15.2 93.9

DISAGREE 4 2 6.1 6.1 100.0

------- ------- -------

TOTAL 33 100.0 100.0




of 117



DQ04 WK-8 Q04 IMPROVED FACIAL ELASTICITY

Valid Cum


STRONG AGREE 1 5 15.2 15.2 15.2

AGREE 2 17 51.5 51.5 66.7

NEUTRAL 3 10 30.3 30.3 97.0

DISAGREE 4 1 3.0 3.0 100.0

------- ------- -------

TOTAL 33 100.0 100.0




- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

DQ05 WK-8 Q05 LIFTED FACIAL SKIN

Valid Cum


STRONG AGREE 1 6 18.2 18.2 18.2

AGREE 2 12 36.4 36.4 54.5

NEUTRAL 3 14 42.4 42.4 97.0

DISAGREE 4 1 3.0 3.0 100.0

------- ------- -------

TOTAL 33 100.0 100.0




- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

DQ06 WK-8 Q06 TIGHTENED FACIAL SKIN

Valid Cum


STRONG AGREE 1 8 24.2 24.2 24.2

AGREE 2 17 51.5 51.5 75.8

NEUTRAL 3 7 21.2 21.2 97.0

DISAGREE 4 1 3.0 3.0 100.0

------- ------- -------

TOTAL 33 100.0 100.0




of 117



DQ07 WK-8 Q07 IMPROVED LINES/WRINKLES

Valid Cum


STRONG AGREE 1 6 18.2 18.2 18.2

AGREE 2 12 36.4 36.4 54.5

NEUTRAL 3 13 39.4 39.4 93.9

DISAGREE 4 2 6.1 6.1 100.0

------- ------- -------

TOTAL 33 100.0 100.0




- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

DQ08 WK-8 Q08 REDUCED LINES/WRINKLES

Valid Cum


STRONG AGREE 1 6 18.2 18.2 18.2

AGREE 2 10 30.3 30.3 48.5

NEUTRAL 3 15 45.5 45.5 93.9

DISAGREE 4 2 6.1 6.1 100.0

------- ------- -------

TOTAL 33 100.0 100.0




- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

DQ09 WK-8 Q09 FACIAL SKIN MORE RADIANT

Valid Cum


STRONG AGREE 1 9 27.3 27.3 27.3

AGREE 2 18 54.5 54.5 81.8

NEUTRAL 3 5 15.2 15.2 97.0

DISAGREE 4 1 3.0 3.0 100.0

------- ------- -------

TOTAL 33 100.0 100.0




of 117



DQ10 WK-8 Q10 FRESH YOUTH INFUSED GLOW

Valid Cum


STRONG AGREE 1 7 21.2 21.2 21.2

AGREE 2 17 51.5 51.5 72.7

NEUTRAL 3 8 24.2 24.2 97.0

DISAGREE 4 1 3.0 3.0 100.0

------- ------- -------

TOTAL 33 100.0 100.0




- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

DQ11 WK-8 Q11 ENHANCED OVERALL APPEARANCE

Valid Cum


STRONG AGREE 1 7 21.2 21.2 21.2

AGREE 2 18 54.5 54.5 75.8

NEUTRAL 3 7 21.2 21.2 97.0

DISAGREE 4 1 3.0 3.0 100.0

------- ------- -------

TOTAL 33 100.0 100.0




- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

DQ12 WK-8 Q12 DID NOT EXPERIENCE IRRITATION

Valid Cum


STRONG AGREE 1 21 63.6 63.6 63.6

AGREE 2 9 27.3 27.3 90.9

NEUTRAL 3 3 9.1 9.1 100.0

------- ------- -------

TOTAL 33 100.0 100.0




of 117



DQ13 WK-8 Q13 RELIEF OF ACTINIC KERTOSIS

Valid Cum


STRONG AGREE 1 2 6.1 15.4 15.4

AGREE 2 4 12.1 30.8 46.2

NEUTRAL 3 6 18.2 46.2 92.3

DISAGREE 4 1 3.0 7.7 100.0

. 1 3.0 MISSING


------- ------- -------

TOTAL 33 100.0 100.0




of 117



XDQ01 WK-8 Q01 REDUCED CAPILLARY REDNESS

Valid Cum


POSITIVE 1-2 1.00 19 57.6 57.6 57.6

NEUT/NEGATIVE 2.00 14 42.4 42.4 100.0

------- ------- -------

TOTAL 33 100.0 100.0


- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

XDQ02 WK-8 Q02 IMPROVED EYELID LAXITY

Valid Cum


POSITIVE 1-2 1.00 19 57.6 57.6 57.6

NEUT/NEGATIVE 2.00 14 42.4 42.4 100.0

------- ------- -------

TOTAL 33 100.0 100.0


- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

XDQ03 WK-8 Q03 IMPROVED FACIAL FIRMNESS

Valid Cum


POSITIVE 1-2 1.00 26 78.8 78.8 78.8

NEUT/NEGATIVE 2.00 7 21.2 21.2 100.0

------- ------- -------

TOTAL 33 100.0 100.0


- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

XDQ04 WK-8 Q04 IMPROVED FACIAL ELASTICITY

Valid Cum


POSITIVE 1-2 1.00 22 66.7 66.7 66.7

NEUT/NEGATIVE 2.00 11 33.3 33.3 100.0

------- ------- -------

TOTAL 33 100.0 100.0


of 117



XDQ05 WK-8 Q05 LIFTED FACIAL SKIN

Valid Cum


POSITIVE 1-2 1.00 18 54.5 54.5 54.5

NEUT/NEGATIVE 2.00 15 45.5 45.5 100.0

------- ------- -------

TOTAL 33 100.0 100.0


- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

XDQ06 WK-8 Q06 TIGHTENED FACIAL SKIN

Valid Cum


POSITIVE 1-2 1.00 25 75.8 75.8 75.8

NEUT/NEGATIVE 2.00 8 24.2 24.2 100.0

------- ------- -------

TOTAL 33 100.0 100.0


- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

XDQ07 WK-8 Q07 IMPROVED LINES/WRINKLES

Valid Cum


POSITIVE 1-2 1.00 18 54.5 54.5 54.5

NEUT/NEGATIVE 2.00 15 45.5 45.5 100.0

------- ------- -------

TOTAL 33 100.0 100.0


- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

XDQ08 WK-8 Q08 REDUCED LINES/WRINKLES

Valid Cum


POSITIVE 1-2 1.00 16 48.5 48.5 48.5

NEUT/NEGATIVE 2.00 17 51.5 51.5 100.0

------- ------- -------

TOTAL 33 100.0 100.0


of 117



XDQ09 WK-8 Q09 FACIAL SKIN MORE RADIANT

Valid Cum


POSITIVE 1-2 1.00 27 81.8 81.8 81.8

NEUT/NEGATIVE 2.00 6 18.2 18.2 100.0

------- ------- -------

TOTAL 33 100.0 100.0


- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

XDQ10 WK-8 Q10 FRESH YOUTH INFUSED GLOW

Valid Cum


POSITIVE 1-2 1.00 24 72.7 72.7 72.7

NEUT/NEGATIVE 2.00 9 27.3 27.3 100.0

------- ------- -------

TOTAL 33 100.0 100.0


- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

XDQ11 WK-8 Q11 ENHANCED OVERALL APPEARANCE

Valid Cum


POSITIVE 1-2 1.00 25 75.8 75.8 75.8

NEUT/NEGATIVE 2.00 8 24.2 24.2 100.0

------- ------- -------

TOTAL 33 100.0 100.0


- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

XDQ12 WK-8 Q12 DID NOT EXPERIENCE IRRITATION

Valid Cum


POSITIVE 1-2 1.00 28 84.8 87.5 87.5

NEUT/NEGATIVE 2.00 4 12.1 12.5 100.0

. 1 3.0 MISSING

------- ------- -------

TOTAL 33 100.0 100.0


of 117

Page 100 IRSI - SKIN CONDITION STUDY #3931OSM0415 8/31/15.3


XDQ13 WK-8 Q13 RELIEF OF ACTINIC KERTOSIS

Valid Cum


POSITIVE 1-2 1.00 6 18.2 46.2 46.2

NEUT/NEGATIVE 2.00 7 21.2 53.8 100.0

. 20 60.6 MISSING

------- ------- -------

TOTAL 33 100.0 100.0


condition - osmosis skin care

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