Biological Anti-aging Efficacy of a Cosmetic Night Cream

NCT06433323 | Completed

• 1 other identifier: RV4983A20240122
• Study Type: observational
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (1)

Treated group : Healthy female adults

Other: Anti-aging cosmetic care product

Interventions

Anti-aging cosmetic care product OTHER

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)

Treated group : Healthy female adults

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Healthy female volunteers.

You may qualify if:

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

Sponsors & Collaborators

• Pierre Fabre Dermo Cosmetique: lead
• SpinControl: collaborator

Study Sites (1)

SpinControl

Tours, Indre et Loire, 37000, France

Location

Study Officials

• Elisabeth GUITTON-OUDET, Dr

  SpinControl

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2024
• First Posted: May 29, 2024
• Study Start: May 23, 2024
• Primary Completion: July 26, 2024
• Study Completion: July 26, 2024
• Last Updated: December 10, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)