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
NCT ID: NCT07166484
Last Updated: 2025-09-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
24 participants
OBSERVATIONAL
2025-09-15
2025-12-05
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Test Group
Cosmetic product RV2666C LA2984
The product is applied, according to randomization, 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.
Interventions
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Cosmetic product RV2666C LA2984
The product is applied, according to randomization, 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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
50 Years
ALL
Yes
Sponsors
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Pierre Fabre Dermo Cosmetique
INDUSTRY
Responsible Party
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Locations
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Skin Research Center
Toulouse, France, France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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RV2666C20250434
Identifier Type: -
Identifier Source: org_study_id
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