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| Name | Class |
|---|---|
| Centre National de la Recherche Scientifique, France | OTHER |
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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
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with active non-segmental vitiligo | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SKIN SAMPLES | Procedure | 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). |
| 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 |
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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:
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Julien SENESCHAL, MD, PhD | Contact | +33 (0)5 56 79 49 63 | julien.seneschal@chu-bordeaux.fr | |
| Sarah CAZENAVE | Contact | +335 57 82 26 63 | sarah.cazenave@chu-bordeaux.fr |
| Name | Affiliation | Role |
|---|---|---|
| Julien SENESCHAL, MD, PhD | University Hospital, Bordeaux | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital of Bordeaux - St André Hospital | Recruiting | Bordeaux | 33000 | France |
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| ID | Term |
|---|---|
| D014820 | Vitiligo |
| ID | Term |
|---|---|
| D017496 | Hypopigmentation |
| D010859 | Pigmentation Disorders |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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monocentric, open-label study, and translational research.
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| BLOOD SAMPLES | Procedure | 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 | Device | narrowband UVB (Nb-UVB) 2 times a week |
|
| Systemic Steroids | Drug | Oral minipuls of systemic steroids (Medrol 16mg twice a week) for 24 weeks |
|
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |