Multizenter-Studie Zur UVA-1 Therapie für Die Hautbeteiligung Bei Systemischer Sklerodermie
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- modified skin score
研究概览
简要总结
Systemic scleroderma (SSc) is a rare chronic inflammatory diseae of the connective tissue involving the skin and internal organs. To date there is no proven therapy for the skin fibrosis available. A number of case reports and small uncontrolled cohort studies suggest that UVA1 therapy may improve skin fibrosis. The aim of this study is therefore to investigate whether treatment UVA1 in deed is effective in treating skin fibrosis in SSc using a randomized, intraindividual half body irradiation protocol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •systemic sclerosis ACR criteria
- •skin fibrosis at least involving the distal third of the lower arm
排除标准
- •photosensitizing drugs
- •recent UV therapy
研究组 & 干预措施
A UVA1 B no UVA1
half body irradiation with random allocation right and left; after three months of treatment treatment of both sides
干预措施: UVA1 (Other)
A UVA1
干预措施: UVA1 (Radiation)
A UVA1
干预措施: UVA1 (Other)
结局指标
主要结局
modified skin score
时间窗: 3 months
次要结局
- modified skin score(6 months)
- histologic examination(3 months)
研究者
Nicolas Hunzelmann
Prof. Dr. N. Hunzelmann
University of Cologne