A Phase 1/2 Study of E6005 in Pediatric Subjects With Atopic Dermatitis
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 62
- 主要终点
- Pharmacokinetics of E6005
研究概览
简要总结
This is a multicenter, double-blind, vehicle-control study of 0.05% and 0.2% E6005 ointment. Pediatric subjects with atopic dermatitis (AD) will be grouped into two; an elder group (childhood - adolescent: 7 to 15 years of age) and a younger group (children: 2 to 6 years of age) according to the sequential cohorts by confirming the safety.
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
- 2 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
1
E6005 0.2% ointment applied twice a day to eczema areas
干预措施: E6005 0.2% (Drug)
2
E6005 0.05% ointment applied twice a day to eczema areas
干预措施: E6005 0.05% (Drug)
3
Placebo ointment applied twice a day to eczema areas
干预措施: Placebo (Drug)
结局指标
主要结局
Pharmacokinetics of E6005
时间窗: Up to 21 Days
The whole blood concentrations of E6005 and major metabolite will be evaluated at each visit
Number of participants with adverse events as a measure of the safety and tolerability of E6005
时间窗: Up to 21 Days
The safety variables include adverse events, clinical laboratory parameters, vital signs and ECG results.
次要结局
- Change from Baseline in severity score of targeted eczema(Baseline and Day 15)
- Change from Baseline in severity assessment by Investigator's Global Assessment (IGA) for targeted eczema and whole application sites(Baseline and Day 15)
- Change from Baseline in intensity of pruritus(Baseline and Day 15)