Clinical trial NCT06433323: Biological Anti-aging Efficacy of a Cosmetic Night Cream
Official title: Evaluation of Biological Anti-aging Efficacy of the Cosmetic Night Cream RV4983A- LA3365 in Women After 2 Months of Daily Use
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Lead sponsor: Pierre Fabre Dermo Cosmetique
Sponsor class: INDUSTRY
Collaborators: name: SpinControl
First posted: 2024-05-29
Enrollment: 46
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy female volunteers.

Brief summary: In a previous study, the cosmetic night cream RV4983A- LA3365 has proven a great efficacy in reducing the clinical signs of skin aging, as well as a great tolerance. The skin structure and composition greatly evolve over the time, and deciphering the biological mechanisms by which the cosmetic night cream RV4983A- LA3365 reduces the signs of skin aging is therefore of great interest to deepen our efficacy evaluation and knowledge on skin aging biology.

Detailed description: An intra-individual, comparative study randomized will be conducted as monocentric trial in female adult

46 subjects are included

4 visits are planned:

* Visit 1 (D1): Inclusion and 1st product application
* Visit 2 (D28): Phone call follow-up
* Visit 3 (D57): End of application and biopsies
* Visit 4 (7 days after V3): Biopsies control and end-of-study

For a subject completing the study, the theoretical investigational product application will be 56 consecutive days up to 59 days maximum.

The maximal duration of participation for a subject is 68 days.

Eligibility criteria: Inclusion Criteria:

* Subject with phototype I, II or III according to the Fitzpatrick scale

Non-inclusion Criteria:

* Criteria related to the subject's health / skin :

  * Subject having any dermatologic condition or characteristics (like tattoo) on any of the target areas liable to interfere with the study assessments
  * Subject having a dermatological condition, an acute, chronic or progressive disease or history of disease liable to interfere with the study data or considered by the Investigator hazardous for the subject or incompatible with the study requirements
  * Subject having received on any of target areas artificial UV exposure, excessive or prolonged exposure to natural sunlight within 2 weeks before the inclusion visit or planning to be exposed to artificial UV, excessive or prolonged natural sunlight during the study and up to 3 months after completion of study participation
  * Subject hirsute on the target areas
  * Subject having contraindication to the local anaesthetic used for biopsies
  * Subject with known immune deficiency
  * Subject with a recognised addiction to alcohol or drug
  * Subject with a scar pathology or pathology with consequences for healing such as diabetes
  * Subject with known history of hepatitis B or C or known HIV positive status
  * Subject with hereditary or acquired haemostasis disorder
  * Smoker \> 10 cigarettes/day with nicotine (or equivalent in electronic cigarettes)
* Criteria related to treatments and/or products:

  * Surgical, chemical or significant invasive treatment on any of the target areas within 6 months before the inclusion or planned during the study
  * Techniques with aesthetic aim on any of the target areas (laser, pulsed flash lamp etc.) or injections of reshaping products (collagen, hyaluronic acid, botulinic toxin etc.) within 6 months before the inclusion or planned during the study
  * Oral isotretinoin taken within 6 months before the inclusion or planned during the study
  * Phototherapy treatment on any of the target areas within 2 months before the inclusion or planned during the study
  * Systemic treatment likely to affect haemostasis (anticoagulants, platelet antiaggregants, etc.) taken within the weeks before the inclusion or planned during the study
  * Systemic treatment may interfere with the healing process (non-steroidal anti-inflammatory drugs, corticosteroids, immunosuppressants) taken within the weeks before the inclusion or planned during the study
  * Systemic treatment or topical treatment applied on any target areas likely to interfere with the local anesthetic (anti-arhythmic, beta blockers etc.) within the weeks before the inclusion or planned during the study
  * Topical non-steroidal anti-inflammatory, dermocorticoids, immunomodulators applied on any of the target areas within the 2 weeks before the inclusion or planned during the study
  * Topical skincare product (e.g. exfoliation, scrub, body mask) applied on any of the target areas within 7 days before the inclusion or planned during the study

Primary outcomes:
measure: Biological efficacy assessed by the analysis of proteins expression related to aging.
timeFrame: Day 57
measure: General safety assessed by the occurence of Adverse Events.
timeFrame: Day 1 to Day 68
measure: Compliance calculated from data reported by the subject in her diary.
timeFrame: Day 1 to Day 57
Secondary outcomes:
Other outcomes:
Locations:
city: Tours
country: France
facility: SpinControl
state: Indre et Loire
Study officials:
affiliation: SpinControl
name: Elisabeth GUITTON-OUDET, Dr
role: PRINCIPAL_INVESTIGATOR
References: