Clinical trial NCT05927272: Deciphering the Vitiligo Transcriptomic Signature Between Repigmented and Non Repigmented Lesions
Official title: Deciphering the Vitiligo Transcriptomic Signature Between Repigmented and Non Repigmented Lesions
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Vitiligo
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
Collaborators: name: Centre National de la Recherche Scientifique, France
First posted: 2023-07-03
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: monocentric, open-label study, and translational research.
Primary purpose: DIAGNOSTIC

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.

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.

Primary outcomes:
measure: Evaluate the evolution of skin biological pathways, assessed by single cell RNAseq in the peri-lesional and lesional skin of a target lesion
timeFrame: Month 6
Secondary outcomes:
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: University Hospital of Bordeaux - St André Hospital
Study officials:
affiliation: University Hospital, Bordeaux
name: Julien SENESCHAL, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: