NCT02103725已完成1 期
A Phase I, Multi-Centre, Randomised, Vehicle-Controlled, Double-Blinded, Explorative Clinical Trial to Evaluate a Left-Right Design in Adults With Mild to Moderate Atopic Dermatitis Over a Treatment Period of Three Weeks
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- LEO Pharma
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Evaluation of the treatment effect defined as total sign score on the treated area at end of the 3 weeks treatment period
研究概览
简要总结
The purpose of this study is to validate a left-right design with respect to detecting a difference in efficacy after 3 weeks of treatment between an active treatment and a vehicle in adults with mild to moderate 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
- Other
- 盲法
- Double (Participant, Investigator)
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
- •Male and female subjects, 18 years or older
- •Subject with atopic dermatitis with mild to moderate disease severity
- •Two symmetrical and comparable atopic dermatitis treatment areas
- •Female volunteers of childbearing potential must either be surgically sterile or agree to use a reliable method of contraception
排除标准
- •Any condition in the target areas that in the opinion of the investigator could interfere with clinical assessments, e.g. acne, infection, rash other than atopic dermatitis, sunburn, hyper- or hypopigmentation, scars
- •Dark-skinned persons whose skin colour prevents reliable clinical assessments
- •Any permanent (or transient within 28 days prior to dosing) disease that may interfere with the subjects safe participation in the trial, with the subjects ability to participate in the trial or with the clinical assessments
- •Pregnancy or breastfeeding
研究组 & 干预措施
pimecrolimus 10 mg/g cream
Experimental
Active drug
干预措施: pimecrolimus 10 mg/g cream (Drug)
Vehicle cream
Placebo Comparator
Placebo drug
干预措施: Vehicle cream (Drug)
结局指标
主要结局
Evaluation of the treatment effect defined as total sign score on the treated area at end of the 3 weeks treatment period
时间窗: 3 weeks
次要结局
- Incidence of adverse events during the 3 weeks treatment period(3 weeks)
研究者
研究点 (1)
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