Clinical trial NCT05895591: Clinical and Biological Anti-aging Efficacy of a Cosmetic Cream
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anti-aging
Lead sponsor: Pierre Fabre Dermo Cosmetique
Sponsor class: INDUSTRY
First posted: 2023-06-08
Enrollment: 33
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

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.)

Primary outcomes:
measure: Assessment of skin network (SRa parameter) by Fringe projection on silicone rubber replica (on one randomized forearm)
timeFrame: Change from baseline to Day 57
measure: Assessment of skin network (SRq parameter) by Fringe projection on silicone rubber replica (on one randomized forearm)
timeFrame: Change from baseline to Day 57
measure: Assessment of sebum metabolites' composition
timeFrame: Change from baseline to Day 57
measure: Assessment of skin metagenomic composition
timeFrame: Change from baseline to Day 57
measure: Expression of cellular communication markers linked to senescence
timeFrame: Day 57
Secondary outcomes:
Other outcomes:
Locations:
city: Tours
country: France
facility: Spincontrol
Study officials:
References: