Translational Assessment of Vitiligo According to Body Locations

NCT ID: NCT06068218

Last Updated: 2025-09-10

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-18
• Study Completion Date: 2026-04-02

Brief Summary

Vitiligo affects 0.5 to 2% of worldwide population and has a demonstrated impact on the quality of life.

Optimal treatment of vitiligo requires to target the auto-immune inflammatory response (to halt the depigmentation process), but also to induce the differentiation of melanocyte stem cells (to induce repigmentation). There is a well demonstrated discrepancy in the repigmentation response between anatomical areas of the body. Face and neck are the best responder with complete or almost complete repigmentation achieved in most cases under treatment. Trunk and limbs could have a complete or almost complete repigmentation in approximately half of the cases. The repigmentation is much more difficult in wrists, elbows, knees, proximal part of the hands. Finally, some areas such as the extremities of hands and feet, palms, soles, are almost impossible to repigment.

The investigator hypothesize that there are some factors that are produced in the skin that prevent (or at least decrease) the differentiation but also probably the migration and proliferation of melanocytes.

Primary objective To compare the mRNA expression of each types of cells in the skin of vitiligo patients compared to healthy volunteers according to body locations

Conditions

Vitiligo

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Patient Group

Group Type: OTHER

Biopsy for the patient group

Intervention Type: OTHER

The investigator will perform a 4mm skin biopsy will be performed on 5 body sites: neck, trunk, elbows, wrist and feet. For vitiligo patients, the biopsies will be taken on a non-depigmented skin.

Volunteer group

Group Type: OTHER

biopsy for the volunteer group

Intervention Type: OTHER

A publicity in the hospital will announce the study, and will be use to recruit the healthy volunteers. The investigator will perform a 4mm skin biopsy will be performed on 5 body sites: neck, trunk, elbows, wrist and feet.

Interventions

Biopsy for the patient group

The investigator will perform a 4mm skin biopsy will be performed on 5 body sites: neck, trunk, elbows, wrist and feet. For vitiligo patients, the biopsies will be taken on a non-depigmented skin.

Intervention Type: OTHER

biopsy for the volunteer group

A publicity in the hospital will announce the study, and will be use to recruit the healthy volunteers. The investigator will perform a 4mm skin biopsy will be performed on 5 body sites: neck, trunk, elbows, wrist and feet.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Men and women with non-segmental vitiligo for the vitiligo group and men and women without any auto-immune disorder for the control group
• ≥ 18 and <70 years
• For women of child-bearing age, a urine pregnancy test (βHCG in urines) will be performed.
• Affiliation to a social security system
• Signed informed consent

Exclusion Criteria

• Pregnant women
• Segmental or mixed vitiligo
• Vitiligo with less than 2 years duration
• Skin auto-immune or inflammatory skin disorders other than vitiligo (ie. active atopic dermatitis, psoriasis, lichen planus…)
• Exposure to sun (with intent to tan or repigment the skin) or artificial UV (UV cabins, lamps or lasers) during the month before inclusion
• Concomitant use of topical or systemic immunosuppressive medication or steroids
• Contra-indication to xylocaine with 2 % adrenalin
• Pregnant or breast-feeding women
• Vulnerable people: minors, adult under guardianship or deprived of freedom, adult under curatorship
• Participants in other clinical therapeutic studies involving a drug that could interfere with the present evaluation

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Centre Hospitalier Universitaire de Nice

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Passeron Thierry, PhD

Role: PRINCIPAL_INVESTIGATOR

CHU de Nice, Service de Dermatologie

Locations

CHU de Nice - Hôpital de l'Archet

Nice, Alpes-maritimes, France

Countries

France

Other Identifiers

23-PP-06

Identifier Type: -

Identifier Source: org_study_id