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

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

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 Overview

• Status: Terminated
• Conditions: Vitiligo
• Intervention / Treatment: Other: Test product; Other: Control Product

• Study Type: Observational
• Enrollment (Actual): 19

Contacts and Locations

Study Locations

• France
  • Gironde
    • Bordeaux, Gironde, France, 33000
      • COSDERMA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Subjects will be enrolled from the investigator's outpatient's reception and/or from the database of the centre. The subjects corresponding to eligibility criteria may receive a phone call, a letter or an e-mail proposing to participate to the clinical study.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Control group	Other: Control Product; Twice daily applications The product is applied to the entire face.
Treated group	Other: Test product; Twice daily applications The product is applied to the entire face.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	assessed after 24 weeks of use

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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)	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)	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	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)	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	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.	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).	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)	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	through study completion, 6 months

Collaborators and Investigators

• Sponsor: Pierre Fabre Dermo Cosmetique
• Investigators: Principal Investigator: Julien SENESCHAL, Pr, University Hospital, Bordeaux

Study record dates

Study Major Dates

• Study Start (Actual): May 23, 2024
• Primary Completion (Actual): October 31, 2025
• Study Completion (Actual): October 31, 2025

Study Registration Dates

• First Submitted: May 7, 2024
• First Submitted That Met QC Criteria: May 31, 2024
• First Posted (Actual): June 6, 2024

Study Record Updates

• Last Update Posted (Actual): May 8, 2026
• Last Update Submitted That Met QC Criteria: May 4, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Adults; Vitiligo; Face; Repigmented; Maintenance of repigmentation
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Skin Diseases; Hypopigmentation; Pigmentation Disorders; Pathological Conditions, Signs and Symptoms; Skin and Connective Tissue Diseases; Vitiligo; Facies; Investigative Techniques; Epidemiologic Research Design; Epidemiologic Methods; Research Design; Methods; Control Groups
• Other Study ID Numbers: RV5098A20230158

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No