Clinical and Biological Anti-aging Efficacy of a Cosmetic Cream

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

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)

Study Overview

• Status: Completed
• Conditions: Anti-aging
• Intervention / Treatment: Other: Anti-aging cosmetic care product

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 Type: Interventional
• Enrollment (Actual): 33
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Tours, France
    • SpinControl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Treated Group; all subjects will apply the study product

Other: Anti-aging cosmetic care product; 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Pierre Fabre Dermo Cosmetique

Study record dates

Study Major Dates

• Study Start (Actual): October 12, 2021
• Primary Completion (Actual): December 7, 2021
• Study Completion (Actual): December 14, 2021

Study Registration Dates

• First Submitted: May 19, 2023
• First Submitted That Met QC Criteria: May 31, 2023
• First Posted (Actual): June 8, 2023

Study Record Updates

• Last Update Posted (Actual): June 8, 2023
• Last Update Submitted That Met QC Criteria: May 31, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: RV4981A20210184

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No