NCT01232985已完成2 期
An Open-Label Pilot Study to Determine the Efficacy and Tolerability of a Device, RD047-26 for the Treatment of Mild to Moderate Atopic Dermatitis With Associated Pruritus in Adults
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 2
- 主要终点
- Investigator Global Assessment
研究概览
简要总结
The purpose of this study is to find out if investigational device, RD047-26, is safe and useful for the treatment of mild to moderate atopic dermatitis.
详细描述
RD047-26, a device, may be tolerable and effective for the treatment of mild to moderate atopic dermatitis with associated pruritus in adults. The treatment effect will be evaluated by the subject and investigator.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Written informed consent
- •Female or male, 18 to 65 years of age and in good general health
- •Clinical diagnosis of stable mild to moderate atopic dermatitis
- •Willing and able to follow study instructions and likely to complete all study requirements
排除标准
- •Severe or uncontrolled asthma
- •Pregnant, nursing, or planning a pregnancy during the study; or is a WOCBP but is not willing to use an effective method of birth control
- •Current enrollment in an investigational drug or device study or participation in such a study within the last 30 days prior to Baseline (Day 0)
结局指标
主要结局
Investigator Global Assessment
时间窗: 2 weeks
Investigator Global Assessment of Atopic Dermatitis Severity
次要结局
- Investigator Pruritus Assessment(2 weeks)
- Subject Itch Assessment(2 weeks)
- Adverse Events(2 weeks)
研究者
研究点 (2)
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