Deciphering the Vitiligo Transcriptomic Signature Between Repigmented and Non Repigmented Lesions
NCT ID: NCT05927272
Last Updated: 2024-04-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
10 participants
INTERVENTIONAL
2024-04-10
2025-10-09
Brief Summary
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Detailed Description
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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
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Patients with active non-segmental vitiligo
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.
narrowband UVB
narrowband UVB (Nb-UVB) 2 times a week
Systemic Steroids
Oral minipuls of systemic steroids (Medrol 16mg twice a week) for 24 weeks
Interventions
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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.
narrowband UVB
narrowband UVB (Nb-UVB) 2 times a week
Systemic Steroids
Oral minipuls of systemic steroids (Medrol 16mg twice a week) for 24 weeks
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
65 Years
ALL
No
Sponsors
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Centre National de la Recherche Scientifique, France
OTHER
University Hospital, Bordeaux
OTHER
Responsible Party
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Principal Investigators
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Julien SENESCHAL, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Bordeaux
Locations
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University Hospital of Bordeaux - St André Hospital
Bordeaux, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CHUBX 2021/54
Identifier Type: -
Identifier Source: org_study_id
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