Efficacy and Safety of BAL4079 in the Treatment of Severe Refractory Chronic Hand Dermatitis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,035
- 试验地点
- 2
- 主要终点
- Physicians global assessment
研究概览
简要总结
The purpose of the study is to determine the therapeutic effect of alitretinoin, a retinoid, on severe, therapy refractory chronic hand dermatitis.
详细描述
Chronic hand dermatitis (CHaD) is a frequent and distressing disease. Conventional treatments yield mostly unsatisfactory results. In addition, chronic hand dermatitis leads to 2-5% of all applications for permanent disability pensions in some western countries. In a therapeutic dose finding study alitretinoin was clinically effective for patients with moderate to severe chronic hand dermatitis refractory to topical treatment.
Patients with severe refractory CHaD will be allocated either of two active treatments or placebo. The primary objective is to demonstrate the response rate based on physicians global assessment of the disease.
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
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic hand dermatitis, all types including hyperkeratotic, vesicular, fingertip dermatitis
- •Lasting for 6 months since initial diagnosis
- •Rated severe
- •Refractory to standard therapy including non-medicated therapy and avoidance of irritants and allergens
- •Refractory to topical steroids
排除标准
- •Female patients who are pregnant or want to become pregnant
- •Female patients of child bearing potential who cannot use or will not commit to using two effective forms of contraception simultaneously
- •Patients whose disease is adequately controlled by standard non-medicated therapy and standard corticosteroid therapy
结局指标
主要结局
Physicians global assessment
at week 12 or 24
次要结局
- Patients global assessment
- at week 12 or 24
- Time to relapse
- Modified total lesion symptom score
- Response rate per treatment group