Anti-aging
Conditions
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.
Interventions
* 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
Sponsors
Pierre Fabre Dermo Cosmetique
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
35 Years to 55 Years
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.)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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 |
Countries
France
Outcome results
None listed