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

Pierre Fabre Dermo Cosmetique50 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Vitiligo

Interventions

Test productOTHER

Twice daily applications The product is applied to the entire face.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Efficacy of the test product RV5098A on the maintenance of pigmentation by the global evolution of facial vitiligo

assessed by the investigator on the face on a 7-point scale (from significant worsening to significant improvement)

Time frame: assessed after 24 weeks of use

Secondary Outcomes

Efficacy of the test product RV5098A on the maintenance of pigmentation by the global evolution of facial vitiligo assessed by the investigator

assessed by the investigator on the face on a 7-point scale (from significant worsening to significant improvement)

Time frame: assessed after 12 weeks of use

Efficacy of the test product RV5098A on the maintenance of pigmentation by the global evolution of facial vitiligo assessed by the subject

assessed by the subject on the face on a 7-point scale (from very much worse to very much improved)

Time frame: assessed after 12 and 24 weeks of use and monthly at home

Efficacy of the test product RV5098A on the maintenance of pigmentation by the severity of facial vitiligo by the investigator

assessed by the investigator on the face on a vitiligo severity scale from 0 (absent) to 3 (complete depigmentation)

Time frame: assessed at baseline and after 12 and 24 weeks of use.

Efficacy of the test product RV5098A on the maintenance of pigmentation by the extent of facial vitiligo

assessed by the investigator on the face with score of extent of vitiligo

Time frame: assessed at baseline and after 12 and 24 weeks of use.

Efficacy of the test product RV5098A on the maintenance of pigmentation by the severity of facial vitiligo by the subject

assessed by the subject on the face on a 5-point scale (from no vitiligo to very severe)

Time frame: assessed at baseline, after 12 and 24 weeks of use and monthly at home

Efficacy of the test product RV5098A on the maintenance of pigmentation by the impact on quality of life assessed by the patient

assessed by the subject with quality-of-life questionnaire

Time frame: assessed at baseline, after 12 and 24 weeks of use

Efficacy of the test product RV5098A on the maintenance of pigmentation by imaging quantification.

Measurement of depigmentation surface on a target lesion of the face by the investigator.

Time frame: assessed at baseline, after 12 and 24 weeks of use.

Cosmetic satisfaction and perceived effects as regards to the use of the test product RV5098A by Cosmetic acceptability questionnaire assessed by the patient

A questionnaire with a scale from 0 to 10 responding to statements about the sensorial experience and effect of the product (0=not at all agree, 10=completely agree).

Time frame: assessed after 12 and 24 weeks of use.

Global tolerance of the test product RV5098A assessed by the investigator.

assessed by the investigator with 5-point scale (from bad to excellent)

Time frame: assessed after 24 weeks of use.

Compliance of the subjects to the test product RV5098A

The subject will report his/her compliance in a subject's diary

Time frame: through study completion, 6 months