Clinical and Biological Anti-aging Efficacy of a Cosmetic Cream

Sponsor

Pierre Fabre Dermo Cosmetique (Industry)

Overall Status

Completed

CT.gov ID

NCT05895591

Collaborator

(none)

Enrollment

Location

Arm

2.1

Actual Duration (Months)

15.9

Patients Per Site Per Month

Study Details

Study Description

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)

Condition or Disease	Intervention/Treatment	Phase
Anti-aging	Other: Anti-aging cosmetic care product	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

33 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

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

Actual Study Start Date :

Oct 12, 2021

Actual Primary Completion Date :

Dec 7, 2021

Actual Study Completion Date :

Dec 14, 2021

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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 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
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

35 Years to 55 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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.)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Spincontrol	Tours		France

Sponsors and Collaborators

Pierre Fabre Dermo Cosmetique

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Pierre Fabre Dermo Cosmetique

ClinicalTrials.gov Identifier:

NCT05895591

Other Study ID Numbers:

RV4981A20210184

First Posted:

Jun 8, 2023

Last Update Posted:

Jun 8, 2023

Last Verified:

Apr 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Jun 8, 2023