NCT01408511已完成2 期
A Multicenter, Open Label Study to Evaluate the Adrenal Suppression Potential of Mapracorat 0.1% Ointment in Adults With Atopic Dermatitis
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
- 23
- 试验地点
- 3
- 主要终点
- HPA axis response to Cosyntropin: Number of subjects with adrenal suppression
研究概览
简要总结
A multicenter, open-label study to evaluate the adrenal suppression potential of Mapracorat 0.1% ointment in adults with atopic dermatitis.
详细描述
Assessment of safety, efficacy, pharmacokinetics and adrenal suppression potential of Mapracorat 0.1% ointment in adults with atopic dermatitis.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed written informed consent
- •Male or female subject aged >= 18 years
- •Diagnosis of atopic dermatitis according to Hanifin and Rajka Criteria
- •Investigator's Global Assessment (IGA) score of 3 (moderate) to 4 (severe) at baseline
- •Normal ACTH response before start of treatment
排除标准
- •Pregnancy or lactation
- •Clinically relevant disease, which could interfere with the study conduct or the evaluation and interpretation of the study results
- •Concomitant medical or dermatological disorder(s), which could interfere with the study conduct or the evaluation and interpretation of the study results
- •Clinically manifest immunosuppressive disorder or known history of malignant disease
研究组 & 干预措施
Arm 1
Experimental
干预措施: Mapracorat (Drug)
结局指标
主要结局
HPA axis response to Cosyntropin: Number of subjects with adrenal suppression
时间窗: measured after 4 weeks of therapy
次要结局
未报告次要终点
研究者
研究点 (3)
Loading locations...
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