NCT00944632已完成2 期
Double-blind, Randomized, Dose Escalation Study of the Efficacy and Safety of ZK 245186 Ointment in Concentrations of 0.01%, 0.03%, and 0.1% Over 4 Weeks in Patients 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
- 64
- 试验地点
- 3
- 主要终点
- Assessment of the severity of atopic dermatitis at target lesion, based on clinical signs of inflammation
研究概览
简要总结
The purpose of this study is to determine the safety and efficacy of three concentrations of ZK 245186 ointment and vehicle on increasing body surface areas for the treatment of atopic dermatitis and to obtain dose-response information for the three concentrations.
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 (Hanifin and Rajka criteria)
- •mild to moderate atopic dermatitis at beginning of study
- •wash-out periods for systemic and topical treatments for atopic dermatitis
- •females must use effective contraception
排除标准
- •pregnant or lactating women
- •conditions that in the opinion of the investigator may pose a risk or interfere with the evaluation of the study
- •wide-spread atopic dermatitis requiring systemic treatment
- •diagnosed with immunocompromised status
- •skin diseases - other than atopic dermatitis - in the treatment area
- •mental handicap or legally incompetent
研究组 & 干预措施
Zk 245186 0.01% ointment
Active Comparator
Active treatment, lowest dose
干预措施: ZK 245186 (Drug)
ZK 245186 0.03% ointment
Active Comparator
Active comparator middle dose
干预措施: ZK 245186 (Drug)
ZK 245186 0.1% ointment
Active Comparator
Active comparator highest dose
干预措施: ZK 245186 (Drug)
Vehicle ointment
Placebo Comparator
Placebo comparator
干预措施: Placebo (vehicle ointment) (Drug)
结局指标
主要结局
Assessment of the severity of atopic dermatitis at target lesion, based on clinical signs of inflammation
时间窗: up to 4 weeks
次要结局
- Investigator's Global Assessment of target area(up to 4 weeks)
研究者
研究点 (3)
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