Clinical and Biological Anti-aging Efficacy of a Cosmetic Cream

Study Overview
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Brief Summary
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The aim of the study is to determine the efficacy of the investigational product Cream  : on skin network after 56 days of daily application on biological parameters linked to cellular communication involved in senescence on sebum composition (metagenomics and metabolomics analysis)

Detailed Description
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This study will be conducted as a monocentric, randomized (for side of product application on forearms), open trial. 4 visits are planned: Visit 1 - Inclusion (D1) Visit 2 - Follow-up visit (D29), a window of +72 hours is allowed for this evaluation, Visit 3 - End of the application period (D57), a window of +72 hours is allowed for this evaluation Visit 4 - Follow-up visit (D7 post-biopsies +/- 24h) For a subject completing the study, the theoretical investigational product application will be 56 consecutive days up to 59 days maximum. The study duration for each subject will be 67 days maximum.

Official Title
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Exploratory Study to Assess Clinical and Biological Anti-aging Efficacy of a Cosmetic Cream in Women After 2 Months of Daily Use, Under Dermatological Control

Conditions
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Anti-aging

Intervention / Treatment
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* Other: Anti-aging cosmetic care product


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: sensitive skin (declaratory judgment) face skin type: combination to normal skin presenting wrinkles and/or finelines on the whole face displaying saggy skin on the face (loss of firmness) presenting a lack of skin radiance, dull complexion and an inhomogeneous skin on the face Exclusion Criteria: Related to the treatment/product: having had any surgery, chemical or significant invasive dermo-treatment on the experimental area considered by the Investigator liable to interfere with the study data having undergone techniques with aesthetic aim on study areas (chemical peel, mechanical dermabrasion, laser, pulsed flash lamp etc.) or having made injections of anti-wrinkle products (collagen, hyaluronic acid, botulinic toxin etc.) having applied products with an anti-aging action (Retinoic acid, retinol, retinaldehyde, A.H.A. etc.)

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 55 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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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treated Group<br>all subjects will apply the study product | Other: Anti-aging cosmetic care product<br>* frequency of application: Once a day (in the morning) modalities of application: Apply the cream on face (according to normal conditions of use) and on treated forearm, massage until complete penetration area: The whole face, neck, neckline and one randomized forearm (external photo-exposed area) the other forearm is untreated duration of investigational product application: 56 days (a window of + 72 hours is allowed) quantity: 2 pressures of product for the whole face, neck and neckline and 1 pressure of product for the treated forearm<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of skin network (SRa parameter) by Fringe projection on silicone rubber replica (on one randomized forearm) | SRa: Average roughness (mm). Average variations in amplitude of the relief integrated into the studied surface. | Change from baseline to Day 57 | 
| Assessment of skin network (SRq parameter) by Fringe projection on silicone rubber replica (on one randomized forearm) | SRq: Roughness with regards to the average quadratic plan (mm). | Change from baseline to Day 57 | 
| Assessment of sebum metabolites' composition | Metabolomics analysis from sebum samples using mass spectrometry | Change from baseline to Day 57 | 
| Assessment of skin metagenomic composition | Metagenomics analysis from sebum samples using targeted DNA sequencing | Change from baseline to Day 57 | 
| Expression of cellular communication markers linked to senescence | RNA expression from skin biopsies using RNA-Seq | Day 57 |