Deciphering the Vitiligo Transcriptomic Signature Between Repigmented and Non Repigmented Lesions

NCT05927272 | Recruiting

• 1 other identifier: CHUBX 2021/54
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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

Conditions

Vitiligo

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Patients with active non-segmental vitiligo

EXPERIMENTAL

Procedure: SKIN SAMPLES; Procedure: BLOOD SAMPLES; Device: narrowband UVB; Drug: Systemic Steroids

Interventions

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).

Patients with active non-segmental vitiligo

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.

Patients with active non-segmental vitiligo

narrowband UVB DEVICE

narrowband UVB (Nb-UVB) 2 times a week

Patients with active non-segmental vitiligo

Systemic Steroids DRUG

Oral minipuls of systemic steroids (Medrol 16mg twice a week) for 24 weeks

Patients with active non-segmental vitiligo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Bordeaux: lead
• Centre National de la Recherche Scientifique, France: collaborator

Study Sites (1)

University Hospital of Bordeaux - St André Hospital

Bordeaux, 33000, France

RECRUITING

MeSH Terms

Conditions

Vitiligo

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Hypopigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Julien SENESCHAL, MD, PhD

  University Hospital, Bordeaux

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: monocentric, open-label study, and translational research.

Study Record Dates

• First Submitted: June 5, 2023
• First Posted: July 3, 2023
• Study Start: April 10, 2024
• Primary Completion: October 9, 2025
• Study Completion: October 9, 2025
• Last Updated: April 19, 2024

Record last verified: 2024-04

Locations

FR (1)