NCT01228513已完成2 期
Double-blind, Randomized, Vehicle-controlled, Multicenter, Multinational, Parallel-group Study of the Efficacy and Safety of ZK245186 Ointment in Concentrations of 0.01, 0.03, and 0.1% Over 4 Weeks in Patients 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
- 263
- 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 placebo in the treatment of atopic dermatitis.
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of atopic dermatitis according to Hanifin and Rajka criteria
- •Body surface area affected by atopic dermatitis at or less than 15% at start of treatment
排除标准
- •Pregnancy and breast-feeding
- •Conditions that may pose a threat to the patient or effect the outcome of the study
- •Wide-spread atopic dermatitis (AD) requiring systemic treatment
- •Immuno-compromized conditions
- •At least 2 weeks after local AD treatment and treatment with systemic antibiotics
- •At least 1 month after systemic AD treatment
研究组 & 干预措施
0.01% ointment
Active Comparator
Lowest concentration
干预措施: ZK245186 (Drug)
0.03% ointment
Active Comparator
Middle concentration
干预措施: ZK245186 (Drug)
0.1% ointment
Active Comparator
Highest concentration
干预措施: ZK245186 (Drug)
Placebo (vehicle without active)
Placebo Comparator
No active ingredient
干预措施: Placebo (vehicle without active ingredient) (Drug)
结局指标
主要结局
Eczema Area and Severity Index (EASI)
时间窗: At baseline
Eczema area and severity index
EASI
时间窗: Measured at the end of 4 weeks of treatment
Eczema area and severity index
次要结局
- Subjects' assessment of pruritus(Measured at baseline)
- Subject's assessment of pruritus(Measured after four weeks of treatment)
研究者
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