Anti-ageing Efficacy of a Cosmetic Formulation Containing NMN (2%) Versus Placebo

Study Overview
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Brief Summary
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The study aims at evaluating skin wrinkling, puffiness and fatigue and dark circle appearance on asian and african-american healthy volunteer cohorts receiving a cosmetic formulation containing NMN (2%). The product will be evaluated after 28 and 56 days of twice-daily application in comparison with a reference cosmetic formulation using clinical scoring under dermatological control. Cosmetic acceptability and future use will also be subjectively evaluated by analysis of the subjects answers to an evaluation questionnaire.

Official Title
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Efficacy Evaluation of the Anti-ageing Effect of a Cosmetic Active Versus Placebo

Conditions
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Wrinkle, Fatigue, Puffiness Around the Eyes

Intervention / Treatment
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* Other: Test product creme
* Other: Reference creme


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy subject Subject having given her free informed, written consent Subject willing to adhere to the protocol and study procedures Subject with normal frontal temperature lower than 37.5°c/100.4°F Subject has read and understood the information given by the investigator related to protection against Novel Coronavirus 19 and necessity to contact the investigator in case of any suspicion of COVID related manifestation (increase of frontal temperature, cough, sore muscles, weakness…) during the study Exclusion Criteria: Pregnant or nursing woman or woman planning to get pregnant during the study Start, stop or change in hormonal treatment (including contraceptive pill) <1.5 months Cutaneous pathology on the study zone (face) Use of topical or systemic treatment during the previous weeks liable to interfere with the assessment of the cutaneous efficacy of the study product Subject having undergone a surgery under general anesthesia within the previous month Know allergy to certain cosmetic or dermato-pharmaceutic products Subject having done injections on face and/or a lifting Excessive exposure to sunlight or UV-rays within the month preceding the study

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Asian skin<br>Twice-daily application for 55 Days | Other: Test product creme<br>* twice daily application of creme containing 2% NMN<br>Other: Reference creme<br>* twice daily application of reference creme<br>|
| African-American skin<br>Twice-daily application for 55 Days | Other: Test product creme<br>* twice daily application of creme containing 2% NMN<br>Other: Reference creme<br>* twice daily application of reference creme<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wrinkles | clinical grading under dermatological control using 1) a 7 points Visual scale of Bazin from absence (0) to pronounced wrinkles (6) for the Asian panel and 2) a 5 points Visual scale of Bazin from absence (0) to pronounced wrinkles (4) for the Afro-American panel | Change from baseline (day 0) at days 28 and 56 of application | 
| Eye bags | clinical grading under dermatological control using 1) a 7 points Visual scale of Bazin from absence (0) to pronounced bags (6) for the Asian panel and 2) a 6 points Visual scale of Bazin from absence (0) to pronounced bags (5) for the Afro-American panel | Change from baseline (day 0) at days 28 and 56 of application | 
| Dark circles | clinical grading under dermatological control using 1) a 6 points Visual scale of Dermscan from absence (0) to important dark circles (6) for the Asian panel and 2) a 5 points Visual scale of Dermscan from absence (0) to important dark circles (4) for the Afro-American panel | Change from baseline (day 0) at days 28 and 56 of application | 
| Relaxed features | clinical grading under dermatological control using a 11 points Non structured scale from relaxed features (0) to looking tired (10) for both panels | Change from baseline (day 0) at days 28 and 56 of application | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective evaluation of the product agreeableness and its effects on skin texture, moisture, puffiness, brightness, youth, swelling, wrinkling, radiance and tone. | Self-assessment questionnaire on a 5 points scale from I disagree (-2) to I agree (+2). | At day 28 of application | 
| Subjective evaluation of the product agreeableness and its effects on skin texture, moisture, puffiness, brightness, youth, swelling, wrinkling, radiance and tone. | Self-assessment questionnaire on a 5 points scale from I disagree (-2) to I agree (+2). | At day 56 of application | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Skin aging