Biological Anti-aging Efficacy of a Cosmetic Night Cream

Evaluation of Biological Anti-aging Efficacy of the Cosmetic Night Cream RV4983A- LA3365 in Women After 2 Months of Daily Use

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Other: Anti-aging cosmetic care product

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.

• Study Type: Observational
• Enrollment (Actual): 46

Contacts and Locations

Study Locations

• France
  • Indre et Loire
    • Tours, Indre et Loire, France, 37000
      • SpinControl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Healthy female volunteers.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Treated group : Healthy female adults	Other: Anti-aging cosmetic care product; This is an intra-individual comparison study.; frequency of application: Once a day (in the evening); modalities of application: Apply the cream on the tested area determined by the randomization; duration of investigational product application: 56 days (a window of + 72 hours is allowed)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Biological efficacy assessed by the analysis of proteins expression related to aging.	Will be determined from skin biopsies.	Day 57
General safety assessed by the occurence of Adverse Events.	The occurrence of Adverse Events will be determined by the subject's spontaneous reporting, the investigator's non-leading questioning and his/her clinical evaluation.	Day 1 to Day 68
Compliance calculated from data reported by the subject in her diary.		Day 1 to Day 57

Collaborators and Investigators

• Sponsor: Pierre Fabre Dermo Cosmetique
• Collaborators: SpinControl
• Investigators: Principal Investigator: Elisabeth GUITTON-OUDET, Dr, SpinControl

Study record dates

Study Major Dates

• Study Start (Actual): May 23, 2024
• Primary Completion (Actual): July 26, 2024
• Study Completion (Actual): July 26, 2024

Study Registration Dates

• First Submitted: May 22, 2024
• First Submitted That Met QC Criteria: May 28, 2024
• First Posted (Actual): May 29, 2024

Study Record Updates

• Last Update Posted (Estimated): December 10, 2024
• Last Update Submitted That Met QC Criteria: December 5, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: RV4983A20240122

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No