NCT01005823已完成1 期
A Safety, Tolerability and Pharmacokinetic Study of LEO 29102 in Subjects With Atopic Dermatitis
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
- 36
- 试验地点
- 1
- 主要终点
- Adverse events, laboratory testing, ECG, vital signs
研究概览
简要总结
The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of 7 days treatment with LEO 29102 in adult patients with 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
- Double (Participant, Investigator)
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
- •Age 18-55 years
- •Atopic dermatitis of 850-1700cm2
- •In good health
- •Criteria for exclusion:
- •Co-morbid conditions
- •Hepatic dysfunction
- •Clinical infection
- •Immunocompromised status
- •Clinically significant illness
- •Use of immunomodulating treatment
- •Medications related to respiratory system or to heart rhythm
排除标准
- 未提供
研究组 & 干预措施
LEO 29102 cream 0.3 mg/g
Active Comparator
干预措施: LEO 29102 cream (Drug)
LEO 29102 cream 1.0 mg/g
Active Comparator
干预措施: LEO 29102 cream (Drug)
LEO 29102 cream 2.5 mg/g
Active Comparator
干预措施: LEO 29102 cream (Drug)
LEO 29102 placebo cream
Placebo Comparator
干预措施: LEO 29102 placebo cream (Drug)
结局指标
主要结局
Adverse events, laboratory testing, ECG, vital signs
时间窗: Day 9
次要结局
- To assess the efficacy of LEO 29102 cream in the treatment of AD(Day 9)
研究者
研究点 (1)
Loading locations...
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