Deciphering the Vitiligo Transcriptomic Signature Between Repigmented and Non Repigmented Lesions

University Hospital, Bordeaux10 enrolled

Overview

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

Treatment strategy: combination of oral mini-pulse of methylprednisolone 16mg twice a week + phototherapy Ultraviolet B (UVB) TL01, 2 times a week. One skin biopsy will be performed at baseline and two skin biopsies at month 3 and month 6 on the same area forearms (excluding skin folds) 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. Principal Objective: The aim of this study is to perform an in-depth analysis of vitiligo skin and blood samples taken during the course of a standard therapy to identify pathways involved in the repigmentation. Secondary Objectives: * Evolution of Vitiligo Disease in relation of patient profile * Evolution of the activity of vitiligo in relation of patient profile The statistical and bioinformatics analyzes will be carried out on the data resulting from research with correlation to clinical data.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Vitiligo

Interventions

SKIN SAMPLESPROCEDURE

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).

BLOOD SAMPLESPROCEDURE

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.

narrowband UVBDEVICE

narrowband UVB (Nb-UVB) 2 times a week

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Criteria: * 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.

Locations (1)

University Hospital of Bordeaux - St André Hospital

Bordeaux, France

RECRUITING

Outcomes

Primary Outcomes

Evaluate the evolution of skin biological pathways, assessed by single cell RNAseq in the peri-lesional and lesional skin of a target lesion

Identify pathways involved in the repigmentation using transcriptomic analyses with Single-cell RNA sequencing (scRNA-seq), comparing molecular/cellular background between vitiligo skin lesions responding to current treatment and lesions not responding to current treatment.

Time frame: Month 6

Central Contacts

Julien SENESCHAL, MD, PhD

CONTACT

+33 (0)5 56 79 49 63 julien.seneschal@chu-bordeaux.fr

Sarah CAZENAVE

CONTACT

+335 57 82 26 63 sarah.cazenave@chu-bordeaux.fr

Data from ClinicalTrials.gov

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