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

Primary Purpose

Vitiligo

Status
Not yet recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
SKIN SAMPLES
BLOOD SAMPLES
narrowband UVB
Systemic Steroids
Sponsored by
University Hospital, Bordeaux
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Vitiligo

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • University Hospital of Bordeaux - St André Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patients with active non-segmental vitiligo

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
June 5, 2023
Last Updated
August 18, 2023
Sponsor
University Hospital, Bordeaux
Collaborators
Centre National de la Recherche Scientifique, France
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1. Study Identification

Unique Protocol Identification Number
NCT05927272
Brief Title
Deciphering the Vitiligo Transcriptomic Signature Between Repigmented and Non Repigmented Lesions
Acronym
STRAVI
Official Title
Deciphering the Vitiligo Transcriptomic Signature Between Repigmented and Non Repigmented Lesions
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 30, 2023 (Anticipated)
Primary Completion Date
January 30, 2025 (Anticipated)
Study Completion Date
January 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Bordeaux
Collaborators
Centre National de la Recherche Scientifique, France

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitiligo

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
monocentric, open-label study, and translational research.
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patients with active non-segmental vitiligo
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
SKIN SAMPLES
Intervention Description
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).
Intervention Type
Procedure
Intervention Name(s)
BLOOD SAMPLES
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
narrowband UVB
Intervention Description
narrowband UVB (Nb-UVB) 2 times a week
Intervention Type
Drug
Intervention Name(s)
Systemic Steroids
Intervention Description
Oral minipuls of systemic steroids (Medrol 16mg twice a week) for 24 weeks
Primary Outcome Measure Information:
Title
Evaluate the evolution of skin biological pathways, assessed by single cell RNAseq in the peri-lesional and lesional skin of a target lesion
Description
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.
Time Frame
Month 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Julien SENESCHAL, MD, PhD
Phone
+33 (0)5 56 79 49 63
Email
julien.seneschal@chu-bordeaux.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Sarah CAZENAVE
Phone
+335 57 82 26 63
Email
sarah.cazenave@chu-bordeaux.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julien SENESCHAL, MD, PhD
Organizational Affiliation
University Hospital, Bordeaux
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital of Bordeaux - St André Hospital
City
Bordeaux
ZIP/Postal Code
33000
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julien SENESCHAL, MD, PhD
Phone
+335.56.79.47.05
Email
juline.seneschal@chu-bordeaux.fr
First Name & Middle Initial & Last Name & Degree
Nicolas ANDREU
Phone
+335 57 82 06 55
Email
nicolas.andreu@chu-bordeaux.fr

12. IPD Sharing Statement

Learn more about this trial

Deciphering the Vitiligo Transcriptomic Signature Between Repigmented and Non Repigmented Lesions

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