Assessment of the Effect of the Product RV2666C Formula LA2984 Compared to an Untreated Area With an Epidermally Ablated Skin Model Obtained With an Erbium YAG Laser on Adults Presenting IV to VI Skin Phototype

Not yet recruiting

• Conditions: Healthy

• Registration Number: NCT07166484
• Lead Sponsor: Pierre Fabre Dermo Cosmetique

Brief Summary

In this study, we assess the efficacy of a cosmetic product in adults with IV to VI skin phototype.

This study is conducted as a monocentric, controlled, compared with an untreated area and randomized for the area of product application.

To perform this clinical study, minimum 20 - maximum 24 subjects (man or woman), aged from 18 to 50 years are enrolled.

The subjects applied the investigational product on an area located on the anterior side of the forearm, following the laser YAG act, once a day and under occlusion from Day 1 to Day 3 included. Then it is applied twice a day in an open way from Day 4 until Day 18 included.

10 visits are planned:

* Visit 1: Inclusion visit = Day 1

* Visit 2 to Visit 5: Intermediate visits = Day 2 to Day 5

* Visit 6: Intermediate visit = Day 8

* Visit 7: Intermediate visit = Day 10

* Visit 8: Intermediate visit = Day 12

* Visit 9: Intermediate visit = Day 15

* Visit 10: End of study visit = Day 19-1

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-09
• Study First Submitted: 2025-09-03
• Study First Submitted QC: 2025-09-03
• Last Update Submitted: 2025-09-03
• Study First Posted: 2025-09-10
• Last Update Posted: 2025-09-10
• Study Start: 2025-09-15
• Primary Completion: 2025-12-05
• Study Completion: 2025-12-05

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time to complete wound healing	Day 1 - Visit 1, Day 2 - Visit 2, Day 3 - Visit 3, Day 4 - Visit 4, Day 5 - Visit 5, Day 8 - Visit 6, Day 10 - Visit 7, Day 12 - Visit 8, Day 15 - Visit 9 and Day 19 - Visit 10.	The wound disappearance is assessed by the investigator by clinical exam of the skin and from standardized photographs taken with a C Cube Caméra©.
The erythema of the skin	Day 1 - Visit 1 (before and after laser YAG act), Day 2 - Visit 2, Day 3 - Visit 3, Day 4 - Visit 4, Day 5 - Visit 5, Day 8 - Visit 6, Day 10 - Visit 7, Day 12 - Visit 8, Day 15 - Visit 9 and Day 19 - Visit 10.	The erythema of the skin is assessed objectively using treatment software from standardized photographs using a C Cube Camera©.
The pigmentation of the skin	Day 1 - Visit 1 (before and after laser YAG act), Day 2 - Visit 2, Day 3 - Visit 3, Day 4 - Visit 4, Day 5 - Visit 5, Day 8 - Visit 6, Day 10 - Visit 7, Day 12 - Visit 8, Day 15 - Visit 9 and Day 19 - Visit 10.	The pigmentation of the skin is assessed objectively using treatment software from standardized photographs using a C Cube Camera©.
The skin marks	Day 2 - Visit 2, Day 3 - Visit 3, Day 4 - Visit 4, Day 5 - Visit 5, Day 8 - Visit 6, Day 10 - Visit 7, Day 12 - Visit 8, Day 15 - Visit 9 and Day 19 - Visit 10.	The skin marks are evaluated by the investigator at the end of the study using standardized photographs taken with a C Cube© Camera and using an NRS-type evaluation scale from 0 to 10.
The wound healing quality	Day 8 - Visit 6, Day 10 - Visit 7, Day 12 - Visit 8, Day 15 - Visit 9 and Day 19 - Visit 10.	The wound healing quality is evaluated by the investigator at the end of the study using standardized photographs taken with a C Cube© Camera and using an NRS-type evaluation scale from 0 to 10.
The global efficacy of the product	Day 19 - Visit 10	The global efficacy of the product is assessed by the subject with a 7-questions questionnaire.
The transepidermal water loss	Day 1 - Visit 1 (before and after laser YAG act), Day 2 - Visit 2, Day 3 - Visit 3, Day 4 - Visit 4, Day 5 - Visit 5, Day 8 - Visit 6, Day 10 - Visit 7, Day 12 - Visit 8, Day 15 - Visit 9 and Day 19 - Visit 10.	The transepidermal water loss is measured by a clinical research technician using a Vapometer©.
Standardized photographs in an illustrative purpose	Day 1 - Visit 1 (before and after laser YAG act), Day 2 - Visit 2, Day 3 - Visit 3, Day 4 - Visit 4, Day 5 - Visit 5, Day 8 - Visit 6, Day 10 - Visit 7, Day 12 - Visit 8, Day 15 - Visit 9 and Day 19 - Visit 10.	Photographs in 2D and 3D are taken using a C Cube Camera©.

Trial Locations

Locations (1)

Skin Research Center; 🇫🇷 Toulouse, France, France