Deciphering the Vitiligo Transcriptomic Signature Between Repigmented and Non Repigmented Lesions

Vitiligo Clinical Trial

— STRAVI  

Official title:

Deciphering the Vitiligo Transcriptomic Signature Between Repigmented and Non Repigmented Lesions

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05927272
• Other study ID #: CHUBX 2021/54
• Status: Recruiting
• Phase: N/A
• Start date: April 10, 2024
• Est. completion date: October 9, 2025

Study information

• Verified date: April 2024
• Source: University Hospital, Bordeaux
• Contact: Julien SENESCHAL, MD, PhD
• Phone: +33 (0)5 56 79 49 63
• Email: julien.seneschal[@]chu-bordeaux.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: October 9, 2025
• Est. primary completion date: October 9, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Vitiligo

Intervention

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).
• 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

Locations

Country	Name	City	State
France	University Hospital of Bordeaux - St André Hospital	Bordeaux

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Bordeaux	Centre National de la Recherche Scientifique, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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