Clinical and Biological Anti-aging Efficacy of a Cosmetic Cream

NCT05895591 | Completed

• 1 other identifier: RV4981A20210184
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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)

Conditions

Anti-aging

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (1)

Treated Group

EXPERIMENTAL

all subjects will apply the study product

Other: Anti-aging cosmetic care product

Interventions

Anti-aging cosmetic care product OTHER

* 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

Treated Group

Eligibility Criteria

• Age: 35 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Pierre Fabre Dermo Cosmetique: lead

Study Sites (1)

Spincontrol

Tours, France

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2023
• First Posted: June 8, 2023
• Study Start: October 12, 2021
• Primary Completion: December 7, 2021
• Study Completion: December 14, 2021
• Last Updated: June 8, 2023

Record last verified: 2023-04

Locations

FR (1)