aknicare - skintech complete brochure.pdf · spf 30 coloured emulsion with solar filters that...

A COMPLETE AND INNOVATIVE RANGE OF MEDICAL DEVICES TOCONTROL MILD-MODERATE COMEDONIC AND INFLAMMATORY ACNE

LET’S FOCUS ON ACNE

AKNICARE®

NEW FORMULA

Dear Doctor,

I would like to take a few moments of your time to introduce you to the AKNICARE® range of products produced by our company.

The AKNICARE® products are ‘Class IIa’ and ‘Class III’ medical devices certified by Istituto Superiore di Sanità (the scientific body of the Italian National Health Service) designed for the purpose of controlling, reducing and treating mild-moderate comedonic and inflammatory acne. These products work by controlling the microenvironment of the pilo-sebaceous unit.

The changes generated by the combination of Triethyl Citrate and Ethyl Linoleate (General Topics patent) at the level of the pilo-sebaceous unit mainly aim at the qualitative and quantitative control of the sebaceous lipids.The consequences are that the sebum production decreases, the hyperkeratinisation of the pilo-sebaceous duct is prevented and impeded, and bacterial colonisation is inhibited.

We have discovered that GT peptide-10, a peptide with an antimicrobial action which efficiently protects microbiologically the products, synergises very well with Triethyl Citrate to control bacterial colonisation.

As a consequence of this logical and multifunctional approach, the AKNICARE® medical devices are effective both for mild-moderate comedonal and inflammatory acne.

AKNICARE® is a systematic and complete range of products structured in such a way to offer you a wide range of therapeutic choices which includes:

• Productsdedicatedtocleanseacneicskin;

• Specifictreatmentproducts;

• Treatmentproductsformakeup,«careup»;

• Treatmentproductsforsunprotection.

We have also developed innovative technologies such as the LIPIFREE® Technology, which increases the products’ efficacy and whose sensorial characteristics increase the patient’s compliance.

I hope that you will find our product range useful for your professional activity.

Best regards,

AKNICARE®

Dr. Gianfranco de Paoli AmbrosiPresident

Mild-moderate comedonic and inflammatory acne

AKNICARE®

3Scientif ically Proven Skin SolutionsScientif ically Proven Skin Solutions

AN INNOVATIVE AND FOCUSED MECHANISM OF ACTION

MULTIPHASE ACTION FOR CONTROLLINGTHE PILO-SEBACEOUS UNIT MICROENVIRONMENT

AKNICARE® Medical Devices perform a synchronised and multiphase action to control the pilo-sebaceous unit microenvironment.

They act simultaneously on the three phases of acne etiopathogenesis which lead to inflammation: seborrhoea, hyperkeratinisation and bacterial colonisation.

ETHYL LINOLEATESCAVENGER OF ROS

SEBORRHOEA

5 α-REDUCTASE

INFLAMMATION

MILD-MODERATECOMEDONIC AND

INFLAMMATORY ACNE

ETHYL LINOLEATE

HYPERKERATINISATION

BACTERIALCOLONIZATION

TRIETHYL CITRATESEBACEOUS

TRIGLYCERIDESHYDROLYSIS

TRIETHYL CITRATE-COOH TRIETHYL CITRATE +

GT peptide-10GRAM+, GRAM-ETHYL LINOLEATE

PPAR-γ ACTIVATION

TRIETHYL CITRATE

direct action indirect action

6%

5,3% 5% 4,8%4,5%

4%3,8% 3,8%


AKNICARE®

CONTROL OF BACTERIAL COLONISATIONINHIBITION OF BACTERIAL COLONISATION INDUCED BY TRIETHYL CITRATE

Triethyl Citrate, once hydrolysed in situ by the bacterial lipases, causes a change in the pilo-sebaceous unit microenvironment that rapidly inhibits bacterial growth (assessment carried out on propionibacterium acnes).

Data on file General Topics: Eurochem

GT PEPTIDE-10 AND TRIETHYL CITRATE

The association between GT peptide-10 and Triethyl Citrate has shown a marked antimicrobial effect when faced with various bacterial families.

Data on file General Topics: Microna

(Graph 1)

TRIETHYL CITRATE ACTIVATION BY BACTERIAL LIPASES

HYDROLYSIS OF TRIETHYL CITRATE INDUCED BY BACTERIAL LIPASES

Bacterial lipases hydrolyse Triethyl Citrate with a consequent release of carboxyl groups and a decrease in pH values at the pilosebaceous unit level.

Data on file General Topics: University of Catania - Department ofPharmaceuticalSciences

(Figure 1)

AfterBefore

CLINICAL EFFICACY DEMONSTRATED IN VITRO

PROTECTION FROM THE HYDROLYSIS OF SEBACEOUS TRIGLYCERIDESPROTECTION OF SEBACEOUS TRIGLYCERIDES FROM HYDROLYSIS INDUCED BY BACTERIAL LIPASES DUE TO TRIETHYL CITRATE

Triethyl Citrate is a preferential substrate for bacterial lipases in comparison with triglycerides.The in vitro data displayed here have also been confirmed by in vivo experiments (data not published).

Data on file General Topics: ABICH

(Graph 2)

15 min 30 min

0,5% 5%1%

82%

45%

13%17%18%

11%

100%

50%

(Graph 3)

7

6

5

4

3

2

1

7

1

0 0,5 1 1,5 2 4 5 6

2

3

4

5

6

Time (hours)pH

t0 t2 t4 t24 t48 t168

Time (hours)

Log(

10) [

PBA]

Linear regression



AKNICARE®

JOURNAL COMPILATION 2007 • BRITISH ASSOCIATION OF DERMATOLOGISTS • BRITISH JOURNAL OF DERMATOLOGY 2007DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED STUDY OF A LOTION CONTAINING TRIETHYL CITRATE AND ETHYL LINOLEATE

IN THE TREATMENT OF ACNE VULGARIS

CONTROLLING SEBORRHOEA

A. Charakida, M. Charakida and A.C. Chu - Department of Dermatology, Hammersmith Hospital, DuCane Road, London W12 0NN, U.K.

(Graph 4)

t0 t12 weeks

86% 92%108%

43%

PLACEBO AKNICARE®

150%

100%

50%

topical use) demonstrated a 20 % reduction in sebum production.This new lotion has demonstrated that it is more efficient in suppressing sebum secretion, reducing sebum production by an average of 53% after 12 weeks of treatment.

The most remarkable result of this study is the evidence that the combination of Triethyl Citrate and Ethyl Linoleate reduces the production of sebum in treated patients in a clinically significant way.In a previous study, the erythromycin-zinc complex (for

ON THE BASIS OF THE RESEARCH CARRIED OUT IT WAS DEMONSTRATED THAT, BY CHANGING AND CONTROLLING THE PILO-SEBACEOUS UNIT MICROENVIRONMENT, THE AKNICARE® MEDICAL DEVICES ACT RAPIDLY AND EFFICIENTLY AGAINST BOTH COMEDONAL AND INFLAMMATORY LESIONS, WHICH LEADS TO PRESUME A SPECIFIC ACTION ON THE

MAIN ETIOPATHOGENIC FACTORS OF ACNE .

CLINICAL EFFICACY DEMONSTRATED IN VIVO


AKNICARE®

SEBORRHOEA HYPERKERATINISATION

INFLAMMATIONBACTERIAL COLONISATION

AKNICARE®


TREATMENT - FACE

AKNICARE® cream(LIPIFREE® Technology)

Specific emulsion to control and diminish the signs of acne.It has a hydrating action which prevents dry skin and has a positive mattifying effect.

Use: apply twice a day, unless otherwise prescribed by your doctor.

Ingredients: Triethyl Citrate, Ethyl Linoleate, Salicylic Acid (0.5%), Zinc Lactate, Hyaluronic Acid, GT peptide-10.

AKNICARE® treatment lotion(Drysyst Technology)

Alcoholic lotion specifically recommended to control and reduce acne symptoms in cases where a rapid and marked action is needed. The lotion is contained in a bottle with an auto-sterilizing applicator.


Ingredients: Triethyl Citrate, Ethyl Linoleate, Salicylic Acid (0.5%), GT peptide-10.

AKNICARE® skin roller(Drysyst Technology)

Alcoholic solution specifically formulated to combat the formation of isolated and contained acneic lesions and to favour their rapid disappearance.

Use: apply using the special roller up to 8 times per day. Only apply on the isolated lesion.

Ingredients: Triethyl Citrate, Ethyl Linoleate, Salicylic Acid (0.5%), GT peptide-10.


AKNICARE®


CLINICAL ASSESSMENT - FACE

BEFORE AFTERPhotographic documentation T0 Photographic documentation

after 12 weeks of treatment

(Graph 5)

(Graph 7)

(Graph 6)

(Graph 8)

(Photo1)

PLACEBO

PLACEBO

PLACEBO

PLACEBO

ACNE SEVERITY (LEEDS REVISED GRADE)

INFLAMMATORY LESIONS (PAPULES AND PUSTULES)

COMEDONIC LESIONS

TOTAL LESIONS (COMEDONES, PAPULES AND PUSTULES)

AKNICARE®

AKNICARE®

AKNICARE®

AKNICARE®

THE SEVERITY OF THE ACNEIC SCENE WAS REDUCED BY AN AVERAGE OF 50% AFTER 12 WEEKS OF TREATMENT

THE NUMBER OF INFLAMMATORY LESIONS WAS REDUCED BY AN AVERAGE OF 63% AFTER 12 WEEKS OF TREATMENT

THE NUMBER OF COMEDONIC LESIONS WAS REDUCED BY AN AVERAGE OF 55% AFTER 12 WEEKS OF TREATMENT

THE TOTAL NUMBER OF LESIONS (COMEDONES, PAPULES AND PUSTULES) WAS REDUCED BY AN AVERAGE OF 57% AFTER 12

WEEKS OF TREATMENT

t0 t12 weeks

t0 t12 weeks

t0 t12 weeks

t0 t12 weeks

10

50

50

100

2

10

10

20

4

20

20

40

6

30

30

60

8

40

40

80

4

20

4

18

2

7

27

52

31

49

14

21

48

86

6

31


AKNICARE®


AKNICARE® CB chest & back(LIPIFREE® Technology)

Oil-free fluid emulsion spray characterised by an excellent tolerability and safety profile. It has been created to control and reduce the symptoms of comedonic and inflammatory acne of light to moderate severity on the chest and back.


Ingredients: Triethyl Citrate, Ethyl Linoleate, Salicylic Acid (0.5%), GT peptide-10, Zinc Lactate, Hyaluronic Acid.

distance 20 cm

APPLICATION

sprayingarea

200 cm2

It is recommended to spray the emulsion while keeping the nozzle at a distance of around 20 cm from the skin surface.Every spray releases around 0.2 ml, which is enough to cover an area of around 200 cm2, for a total of 250 sprays.

LIPIFREE® Technology allows for more effective results and at the same time makes the formulation of the product more pleasant, thus improving the patient’s compliance.In the AKNICARE® products, LIPIFREE® Technology uses Triethyl Citrate as a functional ‘carrier’.The other liposolubles (Ethyl Linoleate, Salicylic Acid) are contained in the matrix made up of Triethyl Citrate and the micelles are stabilized by a special emulsifier characterised by an excellent safety profile.The other water-solubles are dissolved in the external phase of the emulsion.

LIPIFREE® TECHNOLOGY

STANDARD O/W EMULSION LIPIFREE® EMULSION

Trietilcitrato: active lipophilic ingredient GT peptide-10

Oil phase in O/W standard emulsion

In a O/W emulsion the internal oil phase is made up of lipids. The drops of these lipids are spread in the external aqueous phase.

In a O/W LIPIFREE® emulsion, the mainactive ingredient, triethyl citrate becomes a functional ‘carrier’ for the other liposolubes.

CarrierintheLIPIFREE®emulsion

Other main lipophilic active ingredients

TREATMENT - CHEST AND BACK

(Figure 2)


AKNICARE®




REDUCTION OF COMEDONIC AND INFLAMMATORY LESIONS

Open study to evaluate the effectiveness and the tolera-bility of AKNICARE® CB chest & back on 12 patients aged from 13 to 20 years, affected by light to moderate acne on the back and/or chest.

Application of the emulsion for 12 weeks. Checks carried out at 4, 8, 12 weeks.

DataonfileGeneralTopics:SanGallicanoInstitute,Prof.EnzoBerardesca - Rome

Inflammatory lesions Comedonic lesions

TOTAL LESIONS COUNT

(Graph 9)

45

35

25

15

5

Week 4Basal Week 8 Week 12

CLINICAL ASSESSMENT - CHEST AND BACK



(Photo2)


AKNICARE® sunSPF 30

A fine and light emulsion with solar filters that reduce the effect of ultraviolet radiation for both UVB (SPF 30) and UVA rays (high protection). It has been specifically developed for acneic and seborrhoeic skin.

Use: unless otherwise prescribed, after cleansing the skin apply at least two-three times per day, gently massaging until completely absorbed; reapply more frequently during sun exposure, for example after swimming or bathing.

Ingredients: Triethyl Citrate, Hyaluronic Acid, GT peptide-10, solar filters.

AKNICARE® sun teintéeSPF 30

Coloured emulsion with solar filters that reduce the effect of ultraviolet radiation, for both UVB (SPF 30) and UVA rays (high protection). It has been developed specifically for acneic and seborrhoeic skin.

Use: unless otherwise prescribed, apply at least two-three times per day, gently massaging into the skin until a uniform colour is achieved; reapply more frequently during sun exposure, for example after swimming or ba-thing.

Ingredients: Triethyl Citrate, Hyaluronic Acid, GT peptide-10, solar filters.

AKNICARE® cream teintée

Coloured multifunctional emulsion developed to conceal and correct imperfections typical of impure skin, controlling and reducing at the same time the symptoms of acne.Available in two elegant colours: clair and doré.

Use: after cleansing the skin, apply the product, unless otherwise prescribed by your doctor, two to three times per day by massaging gently until you get an even colouring.

Ingredients: Triethyl Citrate, Ethyl Linoleate, Salicylic Acid (0.2%), Zinc Lactate, Hyaluronic Acid, GT peptide-10.


AKNICARE®


TREATMENT - SUN PROTECTION & CARE UP

AKNICARE® cleanser

Monophasic solution with antiseptic and purifying action. It has a light exfoliating action for the daily cleansing of acneic and seborrhoeic skin. It has a positive effect on hyperkeratinisation as it frees the patient from excess greasiness and reduces epidermal thickness. To be used for cleansing face, shoulders, chest and back.

Use: use like a liquid soap; apply on the skin by massaging gently, leave it on to act for about half a minute and then rinse it off well with water.

Ingredients: Triethyl Citrate, Pyruvic Acid, Triclosan.

AKNICARE® gentle cleansing gel

This gel corrects the typical imperfections of sensitive acneic and seborrhoeic skin, which is prone to reddening and getting dehydrated by concomitant treatments. It also has a soothing and antibacterial action.

Use: apply the product on the skin and massage gently; it can be removed by rinsing with water or by using a cotton pad.

Ingredients: Triethyl Citrate, MSM, GT peptide-10.

AKNICARE®


CLEANSING

MOTIVATIONAL RESEARCH

Do you believe that the prescription of specific cleansers is important when treating patients with acne?FROM THE RESULTS OF THE MOTIVATIONAL RESEARCH CARRIED OUT BY GENERAL TOPICS, IT HAS EMERGED THAT DERMATOLOGISTS CONSIDER THAT CLEANSING FOR PATIENTS WITH ACNE IS A FUNDAMENTAL TOOL (VERY USEFUL/USEFUL

> 90%) TO INCREASE THE PATIENT’S COMPLIANCE TO EVERY SUBSEQUENT TREATMENT. Data on file General Topics

(Graph10)

70%

20%10%

0%

Very useful Useful Useless No response

100%

50%

CLEANSING IN PATIENTS WITH ACNE


A COMPLETE AND INNOVATIVE RANGE OF MEDICAL DEVICES TOCONTROL MILD-MODERATE COMEDONIC AND INFLAMMATORY ACNE

GENERAL WARNINGS

USEFUL INFORMATION

General Topics s.r.l. Località Santigaro, 32 - 25010 San Felice del Benaco (BS) - ITALY - Tel. +39 0365 522617 - Fax +39 0365 522619

www.general-topics.com

GEN

ERAL TOPICS

WO

RLDWIDE HEALTH CARE PRODUCTS

Company

THE FUTURE IS OPEN

• DonotusetheseMedicalDevices inthecaseof intoleranceto Salicylic Acid or its derivatives. Do not use for individuals affected by salicylism. Do not use the products if the patient is being treated with anticoagulant medication. Do not use the products if you are allergic to any of the ingredients.

• Unlessotherwiseprescribedbyyourdoctor,donotuse theproducts for children younger than 12 years of age or during pregnancy or breastfeeding.

• Informthepatient that theapplicationofAKNICARE®sunand AKNICARE® sun teintée must be repeated after bathing, showering or any sporting activity.

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AKNICARE®

• AKNICARE® cream, AKNICARE® treatment lotion, AKNICARE® SR skin roller and AKNICARE® CB chest & back Medical Devices contain 0.5% Salicylic Acid.

• AKNICARE® cream teintée Medical Device contain 0.2% Salicylic Acid.

• The product AKNICARE® treatment lotion is a MedicalDevice containing Ethylic Alcohol and it may dry some individuals’ skin; as an alternative use the Medical Device AKNICARE® cream.

• Always bear in mind that even though Salicylic Acidis present in relatively low concentrations (0.5%), AKNICARE® CB chest & back is destined to be applied onto large areas of skin.

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