Efficacy & Tolerance of Cosmetic Product RV5098A on Face Pigmentation Maintenance in Adult Vitiligo Patients.

Pierre Fabre

Status

Enrolling

Conditions

Vitiligo

Treatments

Other: Control Product

Other: Test product

Study type

Observational

Funder types

Industry

Identifiers

NCT06446063

RV5098A20230158

Details and patient eligibility

About

Vitiligo is an autoimmune depigmentation disorder affecting 0.5 to 1% of the population worldwide. Vitiligo lesions are characterized by a progressive loss of pigmentation caused by the disappearance of functioning melanocytes in the epidermis, mainly resulting from the activation of immune cells in a genetically predisposed patient.

Despite major advances in the understanding of the mechanisms of the disease, the treatment remains challenging. Different treatment strategies could lead to cosmetically acceptable repigmentation (>75%), particularly on face and neck. However, after repigmentation, the risk of relapse is estimated at nearly 40% during the first year after stopping treatment.

To date, long-term management remains a challenge. With their topical product RV5098A adapted for patients with vitiligo, Pierre Fabre Laboratories hypothesize that it could be effective in maintaining pigmentation of previously repigmented lesions in adults with facial vitiligo.

Enrollment

50 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.