NCT01702181已完成1 期
A Multiple-Dose (0.3%, 1%, and 3% [w/w]), Randomized, Blinded, Vehicle- and Active Comparator-Controlled, Sequential Dose Cohorts, Multi-Center Trial to Assess the Safety, Pharmacokinetics, and Proof-of-Concept Efficacy of Topical OPA 15406 Ointment, Applied Twice Daily for 28 Days, in Adult 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
- 入组人数
- 92
- 主要终点
- Number of subjects with AEs, SAEs, and % of clinically relevant changes from baseline in Draize Scale, physical examinations, vital signs, laboratory assessments, and electrocardiograms.
研究概览
简要总结
The purpose of this study is to investigate the pharmacokinetics and safety of OPA-15406 in adult subjects 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult subjects 18-65 years of age
- •Diagnosis of atopic dermatitis (AD)
- •AD affecting at least 5% of total Body Surface Area (BSA) for Part 1 and at least 10% BSA for Part 2, not including face, neck, and head
- •Have had a positive but inadequate response to one or more treatment course of standard AD therapy including topical steroids, UV light A, narrowband UV B, and UV light B.
排除标准
- •Use of systemic or topical therapy for contact or atopic dermatitis within 30 days of screening
研究组 & 干预措施
Placebo
Placebo Comparator
Matching placebo.
干预措施: Placebo (Drug)
Tacrolimus
Active Comparator
Tacrolimus 0.1% ointment twice daily for 28 days.
干预措施: Tacrolimus (Drug)
OPA-15406
Experimental
干预措施: OPA-15406 (Drug)
结局指标
主要结局
Number of subjects with AEs, SAEs, and % of clinically relevant changes from baseline in Draize Scale, physical examinations, vital signs, laboratory assessments, and electrocardiograms.
时间窗: 28 days
Measurement of drug levels in the blood of treated patients
时间窗: 28 days
次要结局
- Investigator's Global Assessment (IGA) of Disease Severity at Week 4(28 Days)
研究者
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