NCT01359787已完成2 期
Double-blind, Randomized, Vehicle-controlled, Multicenter, Multinational, Parallel-group Study of the Efficacy and Safety of Mapracorat Ointment in Three Concentrations Over Max. 4 Weeks in Subjects With Atopic Dermatitis (AD)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 197
- 主要终点
- Eczema Area and Severity Index (EASI)
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of three concentrations of a development drug compared to ointment base (vehicle) in subjects with Atopic Dermatitis (AD).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed written informed consent
- •Diagnosis of atopic dermatitis according to Hanifin and Rajka Criteria
- •Willingness of subject to follow all study procedures
- •Willingness to avoid excessive exposure of diseased areas to natural or artificial sunlight
排除标准
- •Pregnancy and breast-feeding
- •Clinically relevant disease, which could interfere with the study conduct or the evaluation and interpretation of the study results
- •Clinically manifested immunosuppressive disorder or known history of malignant disease
- •History of relevant drug and/or food allergies
研究组 & 干预措施
Mapracorat 0.01% Ointment
Active Comparator
Lowest concentration
干预措施: Mapracorat (Drug)
Mapracorat 0.03% Ointment
Active Comparator
Middle concentration
干预措施: Mapracorat (Drug)
Mapracorat 0.1% Ointment
Active Comparator
Highest concentration
干预措施: Mapracorat (Drug)
Vehicle without active
Placebo Comparator
干预措施: Vehicle without active (Drug)
结局指标
主要结局
Eczema Area and Severity Index (EASI)
时间窗: Over all study visits for up to 4 weeks
次要结局
- Subjects´ assessment of pruritus(At baseline and after 4 weeks of treatment)
研究者
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