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EVALUATION OF THE IN VIVO EFFICACY OF ONE COSMETIC PRODUCT USING DERMATOLOGICAL EVALUATION, DIGITAL PHOTOGRAPHY, MEXAMETRY AND SELFASSESSMENT IN HEALTHY ASIAN SKIN TYPE FEMALE SUBJECTS

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SPINCONTROL ASIA Co , Ltd 24028 30, Ayothaya Tower, 17th Floor, Ratchadapisek Road, Huaykwang, Huaykwang, Bangkok 10310, THAILAND Version n°00 – 28 January 2022 CONFIDENTIAL STUDY REPORT Ref XX 2F01.In addition, we can conclude that the tested product AcneAid Spot Gel AntiAcne (Registration No.1116400027568) was very well tolerated by the subjects of the test under our experimental conditions (applied over a period of 7 days) since no unwanted or adverse event has been observed or reported by the subjects of this study.

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SPINCONTROL ASIA Co., Ltd

240/28-30, Ayothaya Tower, 17th Floor, Ratchadapisek Road,

Bangkok 10310, THAILAND Version n°00 – 28 January 2022

CONFIDENTIAL STUDY REPORT

Ref.: XX-2F01-IV-NE21

EVALUATION OF THE IN VIVO EFFICACY OF ONE COSMETIC PRODUCT USING

REFERENCE OF THE TEST PRODUCT:

Acne-Aid Spot Gel Anti-Acne (Registration No.11-1-6400027568)

Study Sponsor:

iNova Pharma (Thailand) Co., LTD

98 Sathorn Square Office Tower, 19th Floor, Unit 1901,

North Sathorn Rd, Silom, Bangrak, Bangkok 10500, THAILAND

DocuSign Envelope ID: A5B885FC-B0EE-49C2-9F0D-9EEB68B835CA

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Spincontrol Asia Co., Ltd XX-2F01-IV-NE21-SS

STUDY REFERENCE: XX-2F01-IV-NE21 EVALUATION OF THE IN VIVO EFFICACY OF ONE COSMETIC PRODUCT USING

NATURE OF THE TESTED PRODUCT AND METHODS:

days, T+6 days and T+7 days

Modalities of use of the product: For Day 1: apply on the 3-5 selected inflamed acne lesion on the face and after 12 hours, re-apply

one more time (at home)

For Day 2-6: apply on the acne affected area on the face and re-apply on the area that identify by

Dermatologist (including acne area, red spots and dark spots) 3 times per day

Quantities correspond to the product instruction

the objective to keep at least 20 subjects at the end of the test has been achieved

greasy skin types; Having a prone to acne skin (mixed acne types, inflammatory acne type and retentional acne type); Having at least 3 inflamed acne lesion (on the whole face); Having at least one red spot cause by post inflammatory acne on face area; Having one or several visible hyper pigmented acne scar on face ≤ 6 months; Having at least one hyper pigmented acne scar on the face with a diameter of 3 mm minimum

TECHNIQUES:

 Dermatological evaluation by a dermatologist of severity of acne lesions

 Dermatological evaluation by a dermatologist of anti-acne

 Digital photography for illustration – illustration photo (before vs after) of two best cases will be provided at end of study (if there are significant improvement of severity of acne lesion)

 Measurement of Erythema index and Melanin index using Mexametry

 Self-assessment using questionnaire

RESULTS AND CONCLUSION:

In our experimental conditions, we have demonstrated:

 Using Dermatological evaluation by a dermatologist of severity of acne lesions that:

The tested product Acne-Aid Spot Gel Anti-Acne (Registration No.11-1-6400027568) was able to show a significant reduction in the severity of inflamed acne lesions after 1 day of application

 Using Dermatological evaluation by a dermatologist of anti-acne that:

The tested product Acne-Aid Spot Gel Anti-Acne (Registration No.11-1-6400027568) was found to be anti-acne towards retentional and inflammatory lesions since the number of retentional and inflammatory lesions was significantly decreased after

7 days of application as counted by the Dermatologist, when compared to baseline Moreover, the tested product Acne-Aid Spot Gel Anti-Acne (Registration No.11-1-6400027568) was also found to be non-comedogenic since the number of whole acne lesions was decreased after 7 days of application as counted by the Dermatologist, when compared to baseline

 Using Mexametry that:

erythema index (the redness intensity of the red spot is reduced) on treated red spot after 1 and 7 days of application when

lighter) after 7 days of application when compared to baseline

 Using Self-assessment questionnaire that:

The tested product Acne-Aid Spot Gel Anti-Acne (Registration No.11-1-6400027568) was very much liked by the subjects of this study over a 7-day period, as seen by high percentages of significantly favorable opinion to questions asked to them about efficacy and cosmeticity of the product In addition, 100% of the subjects agreed that this product does not cause any irritation to the skin

DocuSign Envelope ID: A5B885FC-B0EE-49C2-9F0D-9EEB68B835CA

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Spincontrol Asia Co., Ltd XX-2F01-IV-NE21-SS

In addition, we can conclude that the tested product Acne-Aid Spot Gel Anti-Acne (Registration No.11-1-6400027568) was very well tolerated by the subjects of the test under our experimental conditions (applied over a period of 7 days) since no unwanted or

adverse event has been observed or reported by the subjects of this study

Study Coordinator

Ms Kunyanatt CHALOTHORN

Dermatologist

Dr Kunkanit SUNTIPRARON DocuSign Envelope ID: A5B885FC-B0EE-49C2-9F0D-9EEB68B835CA

07-02-2022

Ngày đăng: 23/10/2022, 06:56

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