Translational Assessment of Vitiligo According to Body Locations

Vitiligo Clinical Trial

— Vitiligo BL  

Official title:

Translational Assessment of Vitiligo According to Body Locations Translational Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06068218
• Other study ID #: 23-PP-06
• Status: Recruiting
• Phase: N/A
• Start date: July 2, 2024
• Est. completion date: October 2, 2025

Study information

• Verified date: November 2023
• Source: Centre Hospitalier Universitaire de Nice
• Contact: Passeron Thierry, PhD
• Phone: +33492036488
• Email: passeron.t[@]chu-nice.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: October 2, 2025
• Est. primary completion date: October 2, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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 (ßHCG 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

Related Conditions & MeSH terms

• Vitiligo

Intervention

Other:
• 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.
• 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.

Locations

Country	Name	City	State
France	CHU de Nice - Hôpital de l'Archet	Nice	Alpes-maritimes

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	skin samples	Transcriptomic profiling by sequencing method will be performed on the skin samples	at inclusion