Deciphering the Vitiligo Transcriptomic Signature Between Repigmented and Non Repigmented Lesions

Study Overview
=================
Brief 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

Detailed Description
-----------------
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.

Official Title
-----------------
Deciphering the Vitiligo Transcriptomic Signature Between Repigmented and Non Repigmented Lesions

Conditions
-----------------
Vitiligo

Intervention / Treatment
-----------------
* Procedure: SKIN SAMPLES
* Procedure: BLOOD SAMPLES
* Device: narrowband UVB
* Drug: Systemic Steroids


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: monocentric, open-label study, and translational research.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients with active non-segmental vitiligo<br> | Procedure: SKIN SAMPLES<br>* 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).<br>Procedure: BLOOD SAMPLES<br>* 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.<br>Device: narrowband UVB<br>* narrowband UVB (Nb-UVB) 2 times a week<br>Drug: Systemic Steroids<br>* Oral minipuls of systemic steroids (Medrol 16mg twice a week) for 24 weeks<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Month 6 |