Deciphering the Vitiligo Transcriptomic Signature Between Repigmented and Non Repigmented Lesions (STRAVI)

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

Study Overview

• Status: Recruiting
• Conditions: Vitiligo
• Intervention / Treatment: Procedure: SKIN SAMPLES; Procedure: BLOOD SAMPLES; Device: narrowband UVB; Drug: Systemic Steroids

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.

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Julien SENESCHAL, MD, PhD; Phone Number: +33 (0)5 56 79 49 63; Email: julien.seneschal@chu-bordeaux.fr
• Study Contact Backup: Name: Sarah CAZENAVE; Phone Number: +335 57 82 26 63; Email: sarah.cazenave@chu-bordeaux.fr

Study Locations

• France
  • Bordeaux, France, 33000
    • Recruiting
    • University Hospital of Bordeaux - St André Hospital
    • Contact: Julien SENESCHAL, MD, PhD; Phone Number: +335.56.79.47.05; Email: juline.seneschal@chu-bordeaux.fr
    • Contact: Nicolas ANDREU; Phone Number: +335 57 82 06 55; Email: nicolas.andreu@chu-bordeaux.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Patients with active non-segmental vitiligo

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

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

Collaborators and Investigators

• Sponsor: University Hospital, Bordeaux
• Collaborators: Centre National de la Recherche Scientifique, France
• Investigators: Principal Investigator: Julien SENESCHAL, MD, PhD, University Hospital, Bordeaux

Study record dates

Study Major Dates

• Study Start (Actual): April 10, 2024
• Primary Completion (Estimated): October 9, 2025
• Study Completion (Estimated): October 9, 2025

Study Registration Dates

• First Submitted: June 5, 2023
• First Submitted That Met QC Criteria: June 21, 2023
• First Posted (Actual): July 3, 2023

Study Record Updates

• Last Update Posted (Actual): April 19, 2024
• Last Update Submitted That Met QC Criteria: April 18, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Pigmentation Disorders; Hypopigmentation; Vitiligo
• Other Study ID Numbers: CHUBX 2021/54

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No