silk eczema relief cream - product evaluation protocol report (group 1 2)

8/12/2019 Silk Eczema Relief Cream - Product Evaluation Protocol Report (Group 1 2)

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Reference: SOP QAC-002-00

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4/26 Coromandel Parade, Blackwood, SA 5051, Australia

Ph.: (+61) 8 8463 0990 Fax: (+61) 8 8278 6360

www.personalcarescience.com.au [email protected]

Product Evaluation Protocol and Report

Company:Belle Natural Skincare

Product:Silk Eczema Relief Cream (SERC)

Formula Reference:BEL001-0

Product evaluation ID:PE005

Revision:004

Supersedes:New

Test Facility: Institute of Personal Care Science

4/26 Coromandel Parade

Blackwood, SA 5051

Australia

Protocol Prepared By:Mariza Ovalle

CONTENTS

Particular Page1.0 INTRODUCTION 2

1.1 Objectives of the protocol 2

1.2 Objectives of the product evaluation 2

1.3 Outline Considerations 2

2.0 MATERIALS AND METHOD 2

2.1 Products 2

2.2 Equipment 3

2.3 Participants and Evaluators 3

2.4 Method 3

2.5 Procedure 4

3.0 OPERATION 5

4.0 VALIDITY 5

5.0 RESULTS 5

6.0 CONCLUSIONS 14

Annex 1Participants List 15

Annex 2Participant Details Form 16

Annex 3Informed Consent Form 17

Annex 4Instructions Card 19

Annex 5Score System Record 20


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1.0 INTRODUCTION1.1 Objectives of the ProtocolThe following protocol is designed to detail the single-blind comparative-group evaluation for Belle

Natural Skincaresproduct, SERC, with Formula Reference BEL001-0. This protocol is in accordance

with clinical testing guidelines and will describe how the product evaluation testing was be

conducted and analysed with required acceptance criteria.

1.2 Objectives of the Product EvaluationThe purpose of this evaluation was to determine the performance of Belle Natural Skincare SERC

against Placebo in:

The management of eczema.

The symptomatic relief of eczema.

Hypothesis 1: Belle Natural Skincare SERC has a significant better activity than Placebo in the

management and symptomatic relief of eczema.

1.3 Outline ConsiderationsThis study was designed as a single-blind group-comparative evaluation, involving 2 groups randomly

selected to receive treatment with:

Belle Natural Skincare SERC

Placebo

The study involved the three times daily application of the assigned product on the affected areas. It

was conducted over a period of 28 days, involving 54 participants divided in 2 groups:

Belle Natural Skincare SERC: 28 participants

Placebo: 26 participants

During the 28 days testing, evaluations were made on the following time points:

T = 0 (Initial)

T = 7 days T = 28 days

2.0 MATERIALS AND METHOD2.1 ProductsThe products used for the evaluation were:

Belle Natural Skincare SERCProduct A

PlaceboProduct B


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1 sample per participant was necessary to conduct the evaluations. The samples were labelled as

Product A or Product B in order to avoid bias. Participants were randomly provided with the product

to be used.

The products were applied only in the affected areas of the following body groups, hereafter known

as the application areas:

Head and neck

Upper limbs

Trunk

Lower limbs

2.2 EquipmentIn order to conduct the product evaluations, the following equipment was required:

Digital camera

Computer

2.3 Participants and Evaluators54 participants from all ages and both sexes were recruited, which should have been medically

diagnosed with atopic eczema. Any other topical treatment being used was discontinued during the

evaluation.

Each participant was assigned with a Participant Code, which was registered in a Participant List(Annex 1); the product (A or B) provided to each participant was also registered in this list.

Participants details were registered in a Participant Details Form (Annex 2), which will remain

confidential at IPCS. A trained evaluator from IPCS labelled the products and randomly assigned

them to the participants. This evaluator also conducted the tests and assessed the results, according

to SOP QAC-002.

An Informed Consent Form (Annex 3) with an information sheet and a certificate of consent was

signed by each participant. An Instructions Card (Annex 4) with the specific steps to follow was given

to each participant.

2.4 Methods2.4.1 EASI Score System tool used to measure the severity and extent of atopic eczema

(Eczema Area and Severity Index) and to evaluate the performance of Belle Natural

Skincare SERC against Placebo.

Four body regions are visually assessed: (1) Head and Neck, (2) Upper Limbs, (3) Trunk,

and (4) Lower Limbs.


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The intensity of redness, thickness, scratching and lichenification of eczema is assessed

for each body region as none, mild, moderate and severe. The approximate percentage of

area affected by eczema is also calculated for each body region. Both intensity and area

values are then used to calculate the EASI Score.

Results were recorded in an excel spread sheet (Annex 5) and are supported with pictures

taken with a digital camera.

2.4.2 Interviewconducted to support the performance of Belle Natural Skincare SERC against

Placebo in the symptomatic relief of eczema.

2.5 Procedure

Initial (T = 0)

2.5.1 The areas of evaluation were clean and free of any substance (lotion, oil, fragrance, etc.).

2.5.2 The evaluator conducted and recorded the corresponding tests to each participant

according to SOP QAC-002.

2.5.3 The evaluator gave the instructions to each participant, along with the corresponding

samples and an Instructions Card (Annex 4) with detail of the steps to follow.

2.5.4 Participants should follow these steps and contact IPCS if any problem or reaction

occurred with the application of the products.

After 7 Days (T = 7)

2.5.5 Participants had to present at IPCS after 7 days of the initial test with the remaining

sample.

2.5.6 The evaluator conducted and recorded the corresponding tests according to SOP QAC-

002.

2.5.7 The evaluator reviewed the remaining samples in order to determine if the products

were being applied appropriately or if more samples were necessary to continue the trial.

2.5.8 Participants must continue the application of the products following the steps detailed on

the Instructions Card.

After 28 Days (T = 28)

2.5.9 Participants had to present at IPCS after 28 days of the initial test with any remaining

sample.

2.5.10The evaluator conducted and recorded the corresponding tests to each participant

according to SOP QAC-002.

2.5.11The evaluator reviewed the remaining samples in order to determine if the products

were applied appropriately.


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3.0 OPERATIONRecord was made to confirm that each step was carried out on each participant exactly as stated

above.

4.0 VALIDITYResults were reviewed and assessed by the evaluator according to SOP QAC-002.

Results were tabulated and percentage of improvement was determined in order to accept or reject

the hypotheses proposed on section 1.2 of this protocol.

5.0 RESULTS54 participants started the evaluation, which were divided in two groups and were randomly

assigned to receive Product A (Belle Natural Skincare SERC/) or Product B (Placebo).

After 7 days,

42 participants presented at IPCS for evaluation.

After 28 days,

39 participants presented at IPCS for evaluation and completed the evaluation.

In summary,

39 participants finalised the Product Evaluation, from which:

- 20participants received Product A

- 19 participants received Product B

15 participants dropped the test.


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5.1 EASI Score SystemThe EASI Score System was used to measure the severity and extent of atopic eczema and to

evaluate the performance of Product A against Product B. The following results were obtained.

Table # 1EASI Score Value by Participant

Participant Code AgeProduct

Assigned

EASI Score

Initial After 7 Days After 28 Days

PE005-A 9 y.o. A 12.2 11.0 7.6

PE005-B 19 y.o. A 15.0 12.2 9.0

PE005-C 19 y.o. B 1.8 2.7 2.7

PE005-D 17 y.o. A 2.8 2.4 1.6

PE005-E 5 y.o. A 16.6 13.8 0.0

PE005-F 21 y.o. A 36.4 34.2 PDT

PE005-G 18 y.o. B 2.4 2.8 PDT

PE005-H 4 m.o. A 9.8 PNE PNE

PE005-I 2 y.o. A 4.8 4.2 3.0

PE005-J 43 y.o. B 2.0 1.2 1.6

PE005-K 51 y.o. B 3.2 3.2 3.6

PE005-L 43 y.o. B 0.4 0.8 PDT

PE005-M 31 y.o. A 1.0 1.0 0.6PE005-N 25 y.o. A 6.4 PNE 3.0

PE005-O 12 y.o. B 3.2 3.2 3.2

PE005-P 17 y.o. A 9.0 6.6 3.9

PE005-Q 43 y.o. A 1.4 PNE 0.4

PE005-R 6 m.o. A 0.9 PNE 0.6

PE005-S 41 y.o. B 1.2 0.6 0.0

PE005-T 4 y.o. B 2.4 2.4 PDT

PE005-U 40 y.o. B 1.8 2.1 3.3

PE005-V 30 y.o. B 1.6 1.6 1.6PE005-W 63 y.o. A 3.6 2.8 0.8

PE005-X 4 y.o. A 1.3 PDT PDT

PE005-Z 15 y.o. B 2.0 PDT PDT

PE005-AA 41 y.o. B 1.8 PDT PDT

PE005-AB 11 m.o. A 22.5 21.5 14.0

PE005-AC 36 y.o. A 16.8 14.2 17.4

PE005-AD 57 y.o. A 2.4 2.0 PNE

PE005-AE 54 y.o. A 1.6 PNE PNE


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PE005-AF 84 y.o. A 8.2 PNE PNE

PE005-AG 12 y.o. A 0.6 0.6 0.0

PE005-AH 21 y.o. A 2.8 1.6 1.2

PE005-AI 2 y.o. B 4.2 PNE PNE

PE005-AJ 21 y.o. A 0.8 0.6 PNE

PE005-AK 28 y.o. B 3.0 3.6 3.0

PE005-AL 18 y.o. A 4.8 3.2 0.0

PE005-AM 53 y.o. A 2.6 2.0 0.0

PE005-AN 36 y.o. A 2.6 1.0 0.0

PE005-AO 38 y.o. B 1.6 3.0 3.0

PE005-AP 36 y.o. B 0.7 1.1 1.1

PE005-AQ 29 y.o. A 3.2 0.4 PNE

PE005-AR 45 y.o. A 1.0 2.4 0.0

PE005-AS 29 y.o. B 1.4 1.3 1.6

PE005-AT 44 y.o. B 2.6 1.8 2.6

PE005-AU 25 y.o. A 1.1 0.9 0.1

PE005-AV 49 y.o. B 3.4 3.8 3.8

PE005-AW 41 y.o. B 1.4 1.8 1.8

PE005-AX 27 y.o. B 1.3 PNE PNE

PE005-AY 41 y.o. B 1.4 PNE 1.4

PE005-AZ 29 y.o. B 0.6 0.5 0.5

PE005-BA 65 y.o. B 1.2 PNE 1.2

PE005-BB 30 y.o. B 1.6 1.6 1.6PE005-BC 30 y.o. B 1.1 1.1 1.1

y.o.years old

m.o.months old

PDTParticipant dropped test

PNEParticipant not evaluated (didnt present

at IPCS for evaluation)

The percentage of improvement of the EASI Scores was also determined for each participant

and product. The following results were obtained:

Table # 2Percentage of Improvement by Participant

Participant Code Product AssignedPercentage of Improvement

After 7 Days After 28 Days

PE005-A A 9.84 37.30

PE005-B A 18.67 40.00

PE005-C B -50.00 -50.00

PE005-D A 14.29 42.86

PE005-E A 16.87 100.00

PE005-F A 6.04 PDT


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PE005-G B -16.67 PDT

PE005-H A PNE PNE

PE005-I A 12.50 37.50

PE005-J B 40.00 20.00

PE005-K B 0.00 -12.50

PE005-L B -100.00 PDT

PE005-M A 0.00 40.00

PE005-N A PNE 53.13

PE005-O B 0.00 0.00

PE005-P A 26.67 56.67

PE005-Q A PNE 71.43

PE005-R A PNE 33.33

PE005-S B 50.00 100.00

PE005-T B 0.00 PDT

PE005-U B -16.67 -83.33

PE005-V B 0.00 0.00

PE005-W A 22.22 77.78

PE005-X A PDT PDT

PE005-Z B PDT PDT

PE005-AA B PDT PDT

PE005-AB A 4.44 37.78

PE005-AC A 15.48 -3.57

PE005-AD A 16.67 PNEPE005-AE A PNE PNE

PE005-AF A PNE PNE

PE005-AG A 0.00 100.00

PE005-AH A 42.86 57.14

PE005-AI B PNE PNE

PE005-AJ A 25.00 PNE

PE005-AK B -20.00 0.00

PE005-AL A 33.33 100.00

PE005-AM A 23.08 100.00PE005-AN A 61.54 100.00

PE005-AO B -87.50 - 87.50

PE005-AP B -57.40 -57.40

PE005-AQ A 87.50 PNE

PE005-AR A 0.00 100.00

PE005-AS B 7.14 -14.29

PE005-AT B 30.77 0.00

PE005-AU A 18.18 90.91


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PE005-AV B -11.76 -11.76

PE005-AW B -28.57 -28.57

PE005-AX B PNE PNE

PE005-AY B PNE 0.00

PE005-AZ B 25.00 25.00

PE005-BA B PNE 0.00

PE005-BB B 0.00 0.00

PE005-BC B 0.00 0.00

PNEParticipant not evaluated (didnt present at IPCS for evaluation)

PDTParticipant dropped test

Table # 3Average Percentage of Improvement by Product

Product AssignedAverage Percentage of Improvement

After 7 Days After 28 Days

A 21.68 63.61

B -11.78 -10.54

Graph # 1Average Percentage of Improvement by Product

-20.00

-10.00

0.00

10.00

20.00

30.00

40.00

50.00

60.00

70.00

Silk Eczema Relief Cream

(SERC)/Natzema

Placebo

Day 7 Day 28


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5.2Visual Testing

Pictures were taken to each participant to support the values assigned in the EASI Score System.

The following pictures show the most remarkable cases.

Picture # 1Participant PE005-B (Product A)


A reduction in scratching and lichenification was seen after 7 and 28 days of application of

Product A.

Picture # 2Participant PE005-I (Product A)


A reduction in redness, thickness, lichenification and area affected was seen after 7 and 28

days of application of Product A.


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Picture # 3Participant PE005-K (Product B)


An increase in thickness was seen after 7 and 28 days of application of Product B.

Picture # 4Participant PE005-N (Product A)

Initial After 28 Days

A reduction in redness and area affected was seen after 28 days of application of Product A;

the participant couldnt attend at his 7 days appointment, therefore results are not available.


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Picture # 5Participant PE005-U (Product B)


An increase in thickness, scratching and lichenification was seen after 7 and 28 days of

application of Product B.

Picture # 6Participant PE005-W (Product A)


A reduction in redness, thickness, lichenification and area affected, in both face and upper

limbs, was seen after 7 and 28 days of application of Product A.


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Picture # 7Participant PE005-AB (Product A)


A reduction in redness, thickness, scratching, lichenification and area affected was seen after

28 days of application of Product A.

Picture # 8Participant PE005-AH (Product A)

Initial After 28 Days

A reduction in redness and area affected was seen after 28 days of application of Product A.


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5.3 Interviews

An interview was conducted to each participant to determine the performance of the product

being used and to support the results obtained with the EASI Score System.

In general, participants using Product A could notice a reduction of redness and itchiness within

time. A few participants experienced the opposite and therefore decided to drop the test.

By the other hand, participants using Product B experienced an increase of redness and

itchiness or no difference at all; therefore some participants decided to drop the test.

6.0 CONCLUSIONSFrom the 54 participants that started the test, 38 completed the evaluation.

In average, Silk Eczema Relief Cream (SERC) provided a 16.14%improvement in the EASI Score

after 7 days of treatment and a 90.88%improvement after 28 days.

Placebo provided negative results: -13.09%improvement after 7 days and -3.69%improvement

after 28 days.

In general, participants using Silk Eczema Relief Cream (SERC) experienced a symptomatic relief

of eczema by reducing irritation and redness. In the opposite, participants using Placebo

experienced an increase on redness and itchiness or no effect at all.

With these results, it can be concluded that Silk Eczema Relief Cream (SERC) has a significant

better activity than Placebo in the management and symptomatic relief of eczema.


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ANNEX 1

PARTICIPANTS LIST

Number Participant Code Group Details

1 PE005-A

Age

Sex

Medically diagnosed atopic eczema

Duration of disease

Treatments being taken

2 PE005-B

Age

Sex


Duration of disease


3 PE005-C

Age

Sex


Duration of disease


4

Age

Sex


Duration of disease


5

Age

Sex


Duration of disease



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ANNEX 2

PARTICIPANT DETAILS FORM

Number Participant Code Group Details

Name

Contact details

Age

Sex


Duration of disease


Symptoms

Other details


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ANNEX 3

INFORMED CONSENT FORM

This Informed Consent Form is for men and women who attend the Institute of Personal Care Science and whoagree to participate in the evaluation to determine the performance Belle Natural Eczema Relief Cream in the


This Informed Consent has two parts:

I. Information Sheet

II. Certificate of Consent

You will be given a copy of the full Informed Consent Form.

PART I: Information Sheet

Introduction

The Institute of Personal Care Science is conducting a research on eczema, which is very common in Australia. We

will provide you information and invite you to be part of this research.

Please let us know if you have any question or if you need more explanation on the research we are conducting.

Purpose

This research is being conducted to determine the performance of Belle Natural Eczema Relief Cream in the


Type of Research Intervention

This research will involve the topical application of the product in the affected areas, three times daily and for a

period of 28 days.

Participant Selection

We are inviting all people that have been medically diagnosed with atopic eczema.

Voluntary Participation

Your participation in this research is entirely voluntary. It is your choice whether to participate or not. If you

decide to participate, you may change your mind later and stop participating even if you agreed earlier.

Information on the Products

The products we are testing are all natural and do not contain any irritant ingredients. No side-effects, toxicity

and adverse reactions are being expected; however if you encounter any problem, please communicate

immediately with us.


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Procedures and Protocol

If you agree to participate in this research, we will provide you with an Instructions Card with more details of the

procedure to follow. Please let us know if you have any question or if you need more explanation on the steps

you need to follow.

Because we need to determine the performance of the product in the management and symptomatic relief of

eczema, we will compare it against placebo (a product with no active ingredients).

To do this, we will put people taking part in this research into two groups. The groups will be randomly selected.

Participants in one group will be given with the test product while participants in the other group will be given

with the placebo. It is important that you dont know which of the two products are given in order to avoid that

results are influenced by what you think or hope might happen. We will be looking after you and the other

participants very carefully during the evaluation; if we are concerned about the effects of any of the products, we

will stop immediately its use.

Confidentiality

We will not be sharing your personal details with anyone and will be kept confidential. Results about you will not

be identified by your name but by a number and will only be provided in this manner.

The knowledge that we get from doing this research will be shared with you before it is made widely available to

the public. Confidential information will not be shared.

Who to Contact

If you encounter any problem or reaction with the use of this product, please stop using immediately and contactus at:

Institute of Personal Care Science (IPCS)

Phone: 08 8463 0990

Email:[email protected]

PART II: Certificate of Consent

By signing below you acknowledge that you have been informed of the nature of the test and what is required of

your involvement. The procedure involved in the test has been explained to you, as have the potential and typesof any side effects. You have also been informed that your participation in this test will remain private; and the

requirement to keep all information regarding this test confidential. You agree not to disclose any information

pertaining to this test or your involvement to any third party, without prior consent from the Institute of Personal

Care Science. You also acknowledge that you are over 18 years of age and capable of consenting to your

participation or the one of your child.

Name Signature Date
mailto:[email protected]:[email protected]:[email protected]:[email protected]


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ANNEX 4

INSTRUCTIONS CARD

Dear Participant,

Thanks for participating on this evaluation!

The objective of this evaluation is to determine the performance of a product in the management and

symptomatic relief of eczema. Please follow these instructions accurately in order to get the best possible results.

The evaluation will be conducted in a period of 28 days divided in 3 time points: initial, after 7 days and after 28

days.

At the beginning of the evaluation you will be given with one container of product.

Instructions

1. Please follow these instructions accurately.

2. Before applying the product, please make sure that the areas of application are clean and free of any other

substance such as body lotion, hand cream, body oil, perfume, etc.

3. Apply approximately 12 fingertips of product in the affected areas of the following body regions:

Head and neck

Upper limbs

Trunk

Lower limbs

4. Allow to dry for 1 minute before putting any clothes on.

5. Do not use any other treatment while conducting the trial.

6. After 7 days of application, please present at IPCS with your sample.

7. Your evaluator will conduct the same tests performed at the beginning of this evaluation and will provide you

with instructions for the following 21 days.

8. If you encounter any problem or reaction with the use of this product, please stop using immediately and

contact us at:

Institute of Personal Care Science (IPCS)

Phone: 08 8463 0990

Email:[email protected]

Thanks again for participating in this evaluation! Your next appointment is on: date of next appointment
mailto:[email protected]:[email protected]:[email protected]:[email protected]


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ANNEX 5

EASI SCORE SYSTEM RECORD

INTENSITY AREA

Absent 0 Nil 0 50 - 69% 4

Mild 1 1 - 9% 1 70 - 89% 5

Moderate 2 10 - 29% 2 90 - 100% 6

Severe 3 30 - 49% 3

INITIAL

Body Region Intensity Score A B C

Head and Neck

Redness

0 0.0 0.0

Thickness

Scratching

Lichenification

Area

Upper Limbs

Redness

0 0.0 0.0

Thickness

Scratching

Lichenification

Area

Trunk

Redness

0 0.0 0.0

Thickness

Scratching

Lichenification

Area

Lower Limbs

Redness

0 0.0 0.0

Thickness

Scratching

Lichenification

Area

TOTAL EASI SCORE 0

AFTER 7 DAYS


Head and Neck

Redness

0 0.0 0.0

Thickness

Scratching

Lichenification

Area


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Upper Limbs

Redness

0 0.0 0.0

Thickness

Scratching

Lichenification

Area

Trunk

Redness

0 0.0 0.0

Thickness

Scratching

Lichenification

Area

Lower Limbs

Redness

0 0.0 0.0

Thickness

Scratching

LichenificationArea

TOTAL EASI SCORE 0

AFTER 28 DAYS


Head and Neck

Redness

0 0.0 0.0

Thickness

Scratching

LichenificationArea

Upper Limbs

Redness

0 0.0 0.0

Thickness

Scratching

Lichenification

Area

Trunk

Redness

0 0.0 0.0

Thickness

Scratching

Lichenification

Area

Lower Limbs

Redness

0 0.0 0.0

Thickness

Scratching

Lichenification

Area

TOTAL EASI SCORE 0

silk eczema relief cream - product evaluation protocol report (group 1 2)

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