Skip to main content
OpenTrials
Completed

NCT Number: NCT05895591

Clinical and Biological Anti-aging Efficacy of a Cosmetic Cream

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)

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Anti-Aging

Age range

35 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Spincontrol

Tours, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.)

Treatment and study plan

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

Primary outcomes

  1. Assessment of skin network (SRa parameter) by Fringe projection on silicone rubber replica (on one randomized forearm)

    Time frame: Change from baseline to Day 57

    SRa: Average roughness (mm). Average variations in amplitude of the relief integrated into the studied surface.

  2. Assessment of skin network (SRq parameter) by Fringe projection on silicone rubber replica (on one randomized forearm)

    Time frame: Change from baseline to Day 57

    SRq: Roughness with regards to the average quadratic plan (mm).

  3. Assessment of sebum metabolites' composition

    Time frame: Change from baseline to Day 57

    Metabolomics analysis from sebum samples using mass spectrometry

  4. Assessment of skin metagenomic composition

    Time frame: Change from baseline to Day 57

    Metagenomics analysis from sebum samples using targeted DNA sequencing

  5. Expression of cellular communication markers linked to senescence

    Time frame: Day 57

    RNA expression from skin biopsies using RNA-Seq

Sponsors and collaborators

Lead sponsor

Pierre Fabre Dermo Cosmetique

Industry

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jun 8, 2023
Registry last updated
Jun 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.