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

NCT06446063 | Recruiting

• 1 other identifier: RV5098A20230158
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Vitiligo

Keywords

Vitiligo; Adults; Face; Repigmented; Maintenance of repigmentation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

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

  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 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 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 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 at baseline, after 12 and 24 weeks of use and monthly at home

Study Arms (2)

Treated group

Other: Test product

Control group

Other: Control Product

Interventions

Test product OTHER

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

Treated group

Control Product OTHER

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

Control group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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
• 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:
• 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.

Sponsors & Collaborators

• Pierre Fabre Dermo Cosmetique: lead

Study Sites (1)

COSDERMA

Bordeaux, Gironde, 33000, France

RECRUITING

MeSH Terms

Conditions

Vitiligo; Facies

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Hypopigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Julien SENESCHAL, Pr

  University Hospital, Bordeaux

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christophe CHAMARD

CONTACT

+335.34.50.65.88; christophe.chamard@pierre-fabre.com

Adeline BACQUEY

CONTACT

+335.34.50.65.33; adeline.bacquey@pierre-fabre.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2024
• First Posted: June 6, 2024
• Study Start: May 23, 2024
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: June 6, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)