Using a cosmetic product to maintain facial pigmentation in adults with vitiligo

Efficacy and Tolerance of the Cosmetic Care Product RV5098A on the Maintenance of Pigmentation on Face in Adult Patients With Vitiligo.

This study is testing a cosmetic product to see if it can help adults with vitiligo keep their skin color after they've already seen improvement from previous treatments.

Quick facts

• Study type: Observational
• Enrollment: 50 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Pierre Fabre Dermo Cosmetique (industry)
• Locations: 1 site (Bordeaux, Gironde)
• Trial ID: NCT06446063 on ClinicalTrials.gov

What this trial studies

This observational study evaluates the efficacy and tolerance of the cosmetic product RV5098A in maintaining pigmentation in adults with facial vitiligo who have previously achieved repigmentation. The study focuses on individuals aged 18 to 75 years who have responded to prior repigmenting treatments. Participants will be monitored for their response to the product in terms of pigmentation maintenance, with the aim of addressing the challenge of relapse after initial treatment. The study is conducted by Pierre Fabre Laboratories at COSDERMA in Bordeaux, Gironde.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with facial vitiligo who have previously achieved sufficient repigmentation.

Not a fit: Patients with active vitiligo or those who have not responded to prior repigmenting treatments may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new approach for maintaining facial pigmentation in vitiligo patients, potentially improving their quality of life.

How similar studies have performed: While there have been various approaches to treating vitiligo, the specific use of RV5098A for maintaining pigmentation is a novel approach.

Eligibility criteria

Inclusion Criteria:

Criteria related to the population:

- Subject aged between 18 and 75 years included.

Criteria related to the disease:

* Subject with facial vitiligo, regardless of its duration.
* having a sufficient repigmentation rate of the vitiligo after repigmenting treatment

Criteria related to treatments and/or products:

- Subject responder to a repigmenting treatment

Non-inclusion Criteria:

Criteria related to the diseases / skin condition:

* Subject with active vitiligo.
* Subject with spontaneous repigmentation without treatment.
* Subject having other dermatological condition, an acute, chronic, or progressive disease or history of disease liable to interfere with the study assessments or considered by the Investigator hazardous for the subject or incompatible with the study requirements.

Criteria related to treatments and/or products:

* Systemic immunomodulatory treatment taken for another pathology, before inclusion, on-going or planned to be established during the study.
* Any topical immunomodulatory treatment applied on the face for another pathology, on-going or planned to be established during the study.
* Any other topical or systemic 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 according to the investigator's assessment.
* Any dietary supplement for vitiligo within 4 weeks before the inclusion visit or planned to be established during the study.

Where this trial is running

Bordeaux, Gironde

• COSDERMA — Bordeaux, Gironde, France (RECRUITING)

Study contacts

• Principal investigator: Julien SENESCHAL, Pr — University Hospital, Bordeaux
• Study coordinator: Christophe CHAMARD

Conditions: Vitiligo, Adults, Face, Repigmented, Maintenance of repigmentation