NCT05927272

Deciphering the Vitiligo Transcriptomic Signature Between Repigmented and Non Repigmented Lesions

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: University Hospital, Bordeaux · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Vitiligo

Interventions

Type	Name	Description
PROCEDURE	SKIN 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).
PROCEDURE	BLOOD 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.
DEVICE	narrowband UVB	narrowband UVB (Nb-UVB) 2 times a week
DRUG	Systemic Steroids	Oral minipuls of systemic steroids (Medrol 16mg twice a week) for 24 weeks

Timeline

• Start date: 2024-04-10
• Primary completion: 2025-10-09
• Completion: 2025-10-09
• First posted: 2023-07-03
• Last updated: 2024-04-19

Locations

1 site across 1 country: France