## Protocol Section
### Identification Module
**NCT ID:** NCT06433323

**Brief Title:** 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

#### Organization Study ID Info
**ID:** RV4983A20240122
#### Organization
**Class:** INDUSTRY
**Full Name:** Pierre Fabre Dermo Cosmetique
### Status Module
#### Completion Date
**Date:** 2024-07-26

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-28

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2024-07-19

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05-23

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-22
**Study First Submit QC Date:** 2024-05-28
### Sponsor Collaborators Module

#### Collaborators

**Class:** UNKNOWN

**Name:** SpinControl

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Pierre Fabre Dermo Cosmetique

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Healthy

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 46

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Other: Anti-aging cosmetic care product

**Label:** Treated group : Healthy female adults

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Treated group : Healthy female adults

**Description:** 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)

**Name:** Anti-aging cosmetic care product

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** Will be determined from skin biopsies.

**Measure:** Biological efficacy assessed by the analysis of proteins expression related to aging.

**Time Frame:** Day 57

**Description:** 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.

**Measure:** General safety assessed by the occurence of Adverse Events.

**Time Frame:** Day 1 to Day 68

**Measure:** Compliance calculated from data reported by the subject in her diary.

**Time Frame:** Day 1 to Day 57

### Eligibility Module

**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

**Healthy Volunteers:** True

**Maximum Age:** 60 Years

**Minimum Age:** 40 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** FEMALE

**Standard Ages:**

- ADULT

**Study Population:** Healthy female volunteers.

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** adeline.bacquey@pierre-fabre.com

**Name:** Adeline BACQUEY

**Phone:** +335.34.50.65.33

**Role:** CONTACT

**Contact 2:**

**Email:** christophe.chamard@pierre-fabre.com

**Name:** Christophe CHAMARD

**Role:** CONTACT

#### Overall Officials

**Official 1:**

**Affiliation:** SpinControl

**Name:** Elisabeth GUITTON-OUDET, Dr

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Misc Info Module

- Version Holder: 2024-05-31
