Vitiligo BL: Translational Assessment of Vitiligo According to Body Locations

Sponsor
Centre Hospitalier Universitaire de Nice (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06068218
Collaborator
(none)
20
1
2
24
0.8

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Other: Biopsy for the patient group
  • Other: biopsy for the volunteer group
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Translational Assessment of Vitiligo According to Body Locations Translational Study
Anticipated Study Start Date :
Oct 2, 2023
Anticipated Primary Completion Date :
Oct 2, 2024
Anticipated Study Completion Date :
Oct 2, 2025

Arms and Interventions

Arm Intervention/Treatment
Other: Patient Group

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.

Other: Volunteer group

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.

Outcome Measures

Primary Outcome Measures

  1. skin samples [at inclusion]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 CHU de Nice - Hôpital de l'Archet Nice Alpes-maritimes France 06200

Sponsors and Collaborators

  • Centre Hospitalier Universitaire de Nice

Investigators

  • Principal Investigator: Passeron Thierry, PhD, CHU de Nice, Service de Dermatologie

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier:
NCT06068218
Other Study ID Numbers:
  • 23-PP-06
First Posted:
Oct 5, 2023
Last Update Posted:
Oct 5, 2023
Last Verified:
Sep 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 5, 2023