RecruitingNot ApplicableNCT05927272

Deciphering the Vitiligo Transcriptomic Signature Between Repigmented and Non Repigmented Lesions


Sponsor

University Hospital, Bordeaux

Enrollment

10 participants

Start Date

Apr 10, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to perform an in-depth analysis of the molecular pathways involved in lesions responding to current treatment and lesions not responding to current treatment


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria9

  • Subject: male or female aged ≥ 18 years and ≤ 65 years
  • Diagnosis of non-segmental (symmetrical) vitiligo with a body surface area involved >5% excluding hands and feet, with lesions located on arms
  • Active non-segmental vitiligo is defined by:
  • Non-segmental vitiligo with new patches or extension of old lesions during the last 6 months AND
  • Presence of hypochromic aspect under Wood's lamp examination and/or perifollicular hypopigmentation under Wood's lamp examination.
  • Able to read, understand, and give documented informed consent
  • Registered in the French Social Security
  • Patients that could receive the combination of oral steroids and phototherapy according the recommendation
  • Signed informed consent form

Exclusion Criteria3

  • Segmental or mixed vitiligo
  • Are unable or unwilling to make themselves available for the duration of the study and/or are unwilling to follow study restrictions/procedures.
  • Are currently enrolled in any other clinical trial involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study.

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Interventions

PROCEDURESKIN SAMPLES

At baseline: one 4 mm Ø skin biopsies: on forearms (excluding skin folds): fresh At month 3 and month 6: Two 4 mm Ø skin biopsies will be performed on the same lesion selected at baseline (one on a repigmented area, one on a non-responded area): fresh Fresh Skin biopsies will be analyzed the same day using Single-cell RNA sequencing (scRNAseq).

PROCEDUREBLOOD SAMPLES

Blood samples will be taken (30 mL) at week 0, week 12, week 24 for the measurement of pro-inflammatory cytokines and chemokines ligands in blood sera.

DEVICEnarrowband UVB

narrowband UVB (Nb-UVB) 2 times a week

DRUGSystemic Steroids

Oral minipuls of systemic steroids (Medrol 16mg twice a week) for 24 weeks


Locations(1)

University Hospital of Bordeaux - St André Hospital

Bordeaux, France

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NCT05927272


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