Comparing the Efficacy of VL-UVA1 Versus NB-UVB on Inducing Repigmentation in Subjects With Generalized Vitiligo
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 2
- 主要终点
- Change in melanin content of vitiligo lesion
研究概览
简要总结
As part of this study, you may have a procedure called phototherapy which involves either VL-UVA or NB-UVB irradiation. NB-UVB phototherapy is not experimental in vitiligo, but use of VL-UVA1 phototherapy in vitiligo is.
The purpose of this pilot study is to determine whether VL-UVA1 or NB-UVB phototherapy more efficiently induces repigmentation in patients with generalized vitiligo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects ≥ 18 years of age with a diagnosis of generalized vitiligo
- •Subjects on a stable topical/oral regimen for the past 3 months and continuing on a stable regimen
- •Subjects able to understand the requirements of the study
- •Subjects able and willing to sign informed consent
排除标准
- •Subjects on photosensitizing medications
- •Subjects receiving any concurrent phototherapy
- •Subjects who plan to use tanning parlors or expose themselves to excess sunlight
- •Subjects with known photosensitivity disorder
- •Subjects with apparent phototoxicity
- •Subjects with unstable vitiligo
- •Subjects currently using bleaching agents
- •Subjects who are pregnant, lactating, or planning on becoming pregnant
- •Subjects who in the opinion of the investigator/sub-investigator, are not appropriate candidates for this study
结局指标
主要结局
Change in melanin content of vitiligo lesion
时间窗: 13 measurements over 26 visits
Change in pigment will be assessed by diffuse reflectance spectroscopy which will measure the melanin content and dyschromia
Change in depigmentation of vitiligo lesion
时间窗: 13 measurements over 26 visits
Change in pigment will be assessed by colorimetry which measures change in pigment
次要结局
未报告次要终点
研究者
Iltefat Hamzavi
Director Investigator Initiated Studies
Henry Ford Health System