NCT00838708已完成2 期
A Phase II, Randomised, Double-blind, Vehicle-controlled, Cross-over Study to Determine the Anti-pruritic Efficacy, Safety and Local Dermal Toleration of SRD174 Cream in Subjects With Atopic Dermatitis.
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 62
- 主要终点
- Measure of intensity and duration of itch episodes
研究概览
简要总结
Pruritus is an essential feature for the diagnosis of atopic dermatitis and may play an important part in disease progression. Itching has a significant impact on the quality of life of AD sufferers, in particular night-time itching leading to sleep disturbance and subsequent poor daytime performance.
The objective of this study is to determine whether SRD174 Cream is a safe and effective therapy for moderate to severe pruritus associated with atopic dermatitis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females aged 18 years and over moderate to severe AD pruritus
- •Written signed and dated informed consent
- •Satisfactory medical assessment with no clinically relevant abnormalities
排除标准
- •Subject with active and pruritic AD covering a body surface area (BSA) > 20%
- •Subject with severe AD defined as an IGA score of 4
- •Subject with current or recurrent skin disease (except AD) that could affect the site of application of action, absorption or disposition of the investigational product, or clinical, laboratory assessments.
- •Subjects with unstable or uncontrolled medical conditions that could require intensive treatment during the course of the study.
- •Subject with known or suspected intolerance or hypersensitivity to the Investigational products or any of the stated ingredients.
- •Subject who has a medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or investigational product administration or may interfere with interpretation of trial results and, in the judgment if the investigator, would make the subject inappropriate for entry into this trial.
研究组 & 干预措施
Vehicle cream
Placebo Comparator
干预措施: vehicle cream (Other)
SRD174 Cream
Experimental
干预措施: SRD174 Cream (Drug)
结局指标
主要结局
Measure of intensity and duration of itch episodes
时间窗: Duration of episode
次要结局
- Safety and local dermal tolerability(4 weeks)
研究者
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