Clinical and Biological Anti-aging Efficacy of a Cosmetic Cream

Not Applicable

Completed

• Conditions: Anti-aging
• Interventions: Other: Anti-aging cosmetic care product

• Registration Number: NCT05895591
• Lead Sponsor: Pierre Fabre Dermo Cosmetique

Brief Summary

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

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.

Study Timeline

• Study Start: 2021-10-12
• Primary Completion: 2021-12-07
• Study Completion: 2021-12-14
• Status Verified: 2023-04
• Study First Submitted: 2023-05-19
• Study First Submitted QC: 2023-05-31
• Last Update Submitted: 2023-05-31
• Study First Posted: 2023-06-08
• Last Update Posted: 2023-06-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 33

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.)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treated Group	Anti-aging cosmetic care product	all subjects will apply the study product

Primary Outcome Measures

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

Trial Locations

Locations (1)

Spincontrol; 🇫🇷 Tours, France