NCT00932074已完成1 期
A Phase 1/2 Study Evaluating the Safety, Tolerability and Efficacy of KP-413 Topical Ointment 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
- 入组人数
- 58
- 试验地点
- 6
- 主要终点
- Investigator's Global Severity Score(IGSS)
研究概览
简要总结
The purpose of this study is to assess the safety, tolerability and efficacy of KP-413 topical ointment compared with vehicle ointment in treating adult subjects with atopic dermatitis (AD).
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Has a clear diagnosis of AD meeting the Hanifin and Rajka criteria for AD that involves both the head/neck and the torso/limbs, and affects 5-30% of the subject's total BSA as determined using the rule of nines
- •Has a Baseline IGSS of 3(moderate) or 4(severe) in the selected treatment area on the torso/limbs, and a Baseline IGSS of 2(mild), 3(moderate) or 4(severe) in the selected treatment area on the head/neck.
- •Female of childbearing potential has a negative pregnancy test and will be using an effective method of contraception during the study.
排除标准
- •Female who is pregnant, nursing an infant, or planning a pregnancy during the study period.
- •Has a Baseline oozing/crusting score of 3(moderate) or greater at the selected treatment area on the head/neck or torso/limbs.
- •Presence of a concurrent skin condition that could interfere with assessment of treatment.
- •Treatment with any investigational drug or device within 30 days or 5 half lives(whichever is longer) prior to the Baseline visit, or concurrent participation in another clinical trial with an investigational drug or device.
研究组 & 干预措施
3% KP-413 Ointment
Experimental
干预措施: KP-413 Ointment (Drug)
1% KP-413 Ointment
Experimental
干预措施: KP-413 Ointment (Drug)
Placebo
Placebo Comparator
干预措施: KP-413 Ointment (Drug)
结局指标
主要结局
Investigator's Global Severity Score(IGSS)
时间窗: 4 weeks
次要结局
- Plasma levels of KP-413(6 weeks)
- Signs and Symptoms of AD(4 weeks)
- Subject's Numerical Rating Scale(NRS) of Pruritus Score(4 weeks)
- Percent of AD-affected body surface area (BSA)(4 weeks)
研究者
研究点 (6)
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