Clinical and Biological Anti-aging Efficacy of a Cosmetic Cream

NCT ID: NCT05895591

Last Updated: 2023-06-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-12
• Study Completion Date: 2021-12-14

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.

Conditions

Anti-aging

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Treated Group

all subjects will apply the study product

Group Type: EXPERIMENTAL

Anti-aging cosmetic care product

Intervention Type: 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

Interventions

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

Intervention Type: OTHER

Eligibility Criteria

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.)

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Pierre Fabre Dermo Cosmetique

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Spincontrol

Tours, , France

Countries

France

Other Identifiers

RV4981A20210184

Identifier Type: -

Identifier Source: org_study_id