Translational Assessment of Vitiligo According to Body Locations Translational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- skin samples
研究概览
简要总结
Vitiligo affects 0.5 to 2% of worldwide population and has a demonstrated impact on the quality of life.
Optimal treatment of vitiligo requires to target the auto-immune inflammatory response (to halt the depigmentation process), but also to induce the differentiation of melanocyte stem cells (to induce repigmentation). There is a well demonstrated discrepancy in the repigmentation response between anatomical areas of the body. Face and neck are the best responder with complete or almost complete repigmentation achieved in most cases under treatment. Trunk and limbs could have a complete or almost complete repigmentation in approximately half of the cases. The repigmentation is much more difficult in wrists, elbows, knees, proximal part of the hands. Finally, some areas such as the extremities of hands and feet, palms, soles, are almost impossible to repigment.
The investigator hypothesize that there are some factors that are produced in the skin that prevent (or at least decrease) the differentiation but also probably the migration and proliferation of melanocytes.
Primary objective To compare the mRNA expression of each types of cells in the skin of vitiligo patients compared to healthy volunteers according to body locations
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men and women with non-segmental vitiligo for the vitiligo group and men and women without any auto-immune disorder for the control group
- •≥ 18 and <70 years
- •For women of child-bearing age, a urine pregnancy test (βHCG in urines) will be performed.
- •Affiliation to a social security system
- •Signed informed consent
排除标准
- •Pregnant women
- •Segmental or mixed vitiligo
- •Vitiligo with less than 2 years duration
- •Skin auto-immune or inflammatory skin disorders other than vitiligo (ie. active atopic dermatitis, psoriasis, lichen planus…)
- •Exposure to sun (with intent to tan or repigment the skin) or artificial UV (UV cabins, lamps or lasers) during the month before inclusion
- •Concomitant use of topical or systemic immunosuppressive medication or steroids
- •Contra-indication to xylocaine with 2 % adrenalin
- •Pregnant or breast-feeding women
- •Vulnerable people: minors, adult under guardianship or deprived of freedom, adult under curatorship
- •Participants in other clinical therapeutic studies involving a drug that could interfere with the present evaluation
研究组 & 干预措施
Patient Group
干预措施: Biopsy for the patient group (Other)
Volunteer group
干预措施: biopsy for the volunteer group (Other)
结局指标
主要结局
skin samples
时间窗: at inclusion
Transcriptomic profiling by sequencing method will be performed on the skin samples
次要结局
未报告次要终点