Clinical and Biological Anti-aging Efficacy of a Cosmetic Cream

Anti-aging Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05895591
• Other study ID #: RV4981A20210184
• Status: Completed
• Phase: N/A
• Start date: October 12, 2021
• Est. completion date: December 14, 2021

Study information

• Verified date: April 2023
• Source: Pierre Fabre Dermo Cosmetique
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: December 14, 2021
• Est. primary completion date: December 7, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 35 Years to 55 Years

Eligibility

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.)

Related Conditions & MeSH terms

• Anti-aging

Intervention

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

Locations

Country	Name	City	State
France	Spincontrol	Tours

Sponsors (1)

Lead Sponsor	Collaborator
Pierre Fabre Dermo Cosmetique

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Assessment of sebum metabolites' composition	Metabolomics analysis from sebum samples using mass spectrometry	Change from baseline to Day 57
Primary	Assessment of skin metagenomic composition	Metagenomics analysis from sebum samples using targeted DNA sequencing	Change from baseline to Day 57
Primary	Expression of cellular communication markers linked to senescence	RNA expression from skin biopsies using RNA-Seq	Day 57