Translational Assessment of Vitiligo According to Body Locations

Not Applicable

Active, not recruiting

• Conditions: Vitiligo
• Interventions: Other: biopsy for the volunteer group; Other: Biopsy for the patient group

• Registration Number: NCT06068218
• Lead Sponsor: Centre Hospitalier Universitaire de Nice

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-09-05
• Study First Submitted QC: 2023-10-03
• Study First Posted: 2023-10-05
• Study Start: 2024-06-18
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-24
• Last Update Posted: 2025-03-25
• Primary Completion: 2025-06-18
• Study Completion: 2026-04-02

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Volunteer group	biopsy for the volunteer group	-
Patient Group	Biopsy for the patient group	-

Primary Outcome Measures

Name	Time	Method
skin samples	at inclusion	Transcriptomic profiling by sequencing method will be performed on the skin samples

Trial Locations

Locations (1)

CHU de Nice - Hôpital de l'Archet; 🇫🇷 Nice, Alpes-maritimes, France