NCT00519675已完成3 期
Open Label Treatment of Patients With Chronic Hand Dermatitis Who Have Participated in a Previous Clinical Trial Involving Oral Alitretinoin
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 4
- 主要终点
- Safety assessments
研究概览
简要总结
The purpose of the study is to investigate the safety and efficacy of alitretinoin in chronic hand eczema that is refractory to topical corticosteroids.
详细描述
Chronic hand eczema is a frequent and distressing disease. The course of the disease is of chronic-relapsing nature. In a phase III study alitretinoin was clinically effective for patients with severe chronic hand eczema refractory to topical treatment. This study investigates the safety and efficacy of alitretinoin who previously have participated in a clinical trial involving alitretinoin.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Previous participation in therapeutic trials involving chronic hand eczema
- •Relapse of chronic hand eczema, defined as 75% of the baseline initial total lesion symptom score
排除标准
- •Patients whose disease is adequately controlled by standard non-medicated skin care and topical corticosteroid therapy
结局指标
主要结局
Safety assessments
次要结局
- Efficacy (Physicians Global Assessment)
研究者
研究点 (4)
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