Translational Assessment of Vitiligo According to Body Locations

NCT06068218 | Completed

• 1 other identifier: 23-PP-06
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• skin samples

  Transcriptomic profiling by sequencing method will be performed on the skin samples

  at inclusion

Study Arms (2)

Patient Group

OTHER

Other: Biopsy for the patient group

Volunteer group

OTHER

Other: biopsy for the volunteer group

Interventions

Biopsy for the patient group 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.

Patient Group

biopsy for the volunteer group 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.

Volunteer group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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…)
• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (1)

CHU de Nice - Hôpital de l'Archet

Nice, Alpes-maritimes, 06200, France

Location

MeSH Terms

Conditions

Vitiligo

Interventions

Biopsy

Condition Hierarchy (Ancestors)

Hypopigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Passeron Thierry, PhD

  CHU de Nice, Service de Dermatologie

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2023
• First Posted: October 5, 2023
• Study Start: June 18, 2024
• Primary Completion: February 19, 2025
• Study Completion: December 23, 2025
• Last Updated: March 18, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)