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

Pierre Fabre

Status: Not yet enrolling

Conditions: Healthy

Treatments: Other: Cosmetic product RV2666C LA2984

Study type: Observational

Funder types: Industry

Identifiers

NCT07166484

RV2666C20250434

Details and patient eligibility

About

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

Enrollment: 24 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Main inclusion criteria :

• Man or woman from 18 to 50 years old
• Phototype IV to VI according to the Fitzpatrick classification
• Subject smoking ≤ 10 cigarettes/day containing nicotine, paper or e-cigarette equivalent
• Subject agreeing not to expose his forearms to UV (natural or artificial) throughout the duration of the study and up to 3 months after the end of participation in the study
• Subject protected by a tetanus vaccination according to the vaccination schedule established by the Public Health Agency

Main non-inclusion criteria:

• Subject suffering from a disease liable to affect the wound healing process according to the opinion of the investigator
• Subject with a known history of allergy or contact dermatitis induced in particular by the latex, the plaster, the local anesthetic, the local antiseptic or one of the components of the study product
• Subject with a disease including skin disease in progress on the upper limbs that may interfere with the interpretation of the evaluation criteria according to the opinion of the investigator
• Topical or oral treatment established or modified during the previous weeks or planned to be established or modified during the study, liable to interfere with the evaluation of the efficacy or cutaneous tolerance of the investigational product according to the investigator's assessment

Trial design

24 participants in 1 patient group

Test Group

Treatment:

Other: Cosmetic product RV2666C LA2984