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OpenTrials
Completed

NCT Number: NCT06068218

Translational Assessment of Vitiligo According to Body Locations

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

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Nice - Hôpital de l'Archet

Nice, Alpes-maritimes, 06200, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. skin samples

    Time frame: at inclusion

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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Official study title

Translational Assessment of Vitiligo According to Body Locations Translational Study

Acronym: Vitiligo BL

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 5, 2023
Registry last updated
Mar 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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