Deciphering the Vitiligo Transcriptomic Signature Between Repigmented and Non Repigmented Lesions
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Evaluate the evolution of skin biological pathways, assessed by single cell RNAseq in the peri-lesional and lesional skin of a target lesion
研究概览
简要总结
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
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Patients with active non-segmental vitiligo
干预措施: SKIN SAMPLES (Procedure)
Patients with active non-segmental vitiligo
干预措施: BLOOD SAMPLES (Procedure)
Patients with active non-segmental vitiligo
干预措施: narrowband UVB (Device)
Patients with active non-segmental vitiligo
干预措施: Systemic Steroids (Drug)
结局指标
主要结局
Evaluate the evolution of skin biological pathways, assessed by single cell RNAseq in the peri-lesional and lesional skin of a target lesion
时间窗: Month 6
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.
次要结局
未报告次要终点