Randomized Controlled Trial of Thalidomide vs Placebo in Skin Sarcoidosis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Size of target skin lesions at 3 months.
研究概览
简要总结
Sarcoidosis is a multisystem disease involving most frequently the lung, the eyes, the lymph nodes and the skin. Skin lesions may be disfiguring and impair the quality of life. Thalidomide is a multi-target drug that has been shown to be of benefit in skin sarcoidosis in case reports. The objective is to assess the efficacy and tolerance of thalidomide in skin sarcoidosis.
详细描述
The study consists in comparing thalidomide to placebo in skin sarcoidosis. Patients with sarcoidosis not necessitating a high-dose corticosteroid regimen, and assessable skin lesions, are eligible. They are randomized and receive either thalidomide or placebo for 3 months. Then they are given Thalidomide for a 3-month open-label period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- •Biopsy proven skin sarcoidosis
- •Assessable target skin lesions
排除标准
- •Rapidly evolving sarcoidosis
- •Patients necessitating a corticosteroid regimen of more than 15mg per day.
- •Women not willing to undertake a contraceptive method.
- •Neurologic impairment
- •Past treatment with Thalidomide
- •Renal impairment
研究组 & 干预措施
1
THALIDOMIDE
干预措施: THALIDOMIDE (Drug)
结局指标
主要结局
Size of target skin lesions at 3 months.
时间窗: during de study
Size of target skin lesions at 3 months.
次要结局
- Physician global assessment at 3 months. Functional assessment of other organs. Side-effects at 3 months.(during the study)