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

University Hospital of Bordeaux

Status

Enrolling

Conditions

Vitiligo

Treatments

Procedure: SKIN SAMPLES

Drug: Systemic Steroids

Device: narrowband UVB

Procedure: BLOOD SAMPLES

Study type

Interventional

Funder types

Other

Identifiers

NCT05927272

CHUBX 2021/54

Details and patient eligibility

About

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

Full 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.

Enrollment

10 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.