NCT02219633已完成1 期
An Explorative Trial Evaluating the Effect of LEO 39652 Cream in Adults With Mild to Moderate Atopic Dermatitis (AD)
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- LEO Pharma
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Total sign score at end of treatment
研究概览
简要总结
The aim of this trial is to assess the efficacy of LEO 39652 cream compared with LEO 39652 cream vehicle in adults with mild to moderate AD after 3 weeks of treatment.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with Atopic Dermatitis (AD) as defined by Hanifin and Rajka criteria and with mild to moderate disease severity (IGA 2 or 3)
- •Two symmetrical and comparable Entire Treatment Areas, on the same body region (left and right part)
- •Subjects must be in good health
- •Female subjects of childbearing potential and male subjects must be willing to consent to using high effective methods of contraception
排除标准
- •Any condition in the treatment areas that in the opinion of the investigator could interfere with clinical assessments, e.g. acne, infection, rash (other than atopic dermatitis), sunburn, hyper-or hypopigmentation, scars
- •Dark-skinned persons (i.e. skin type IV to VI according to Fitzpatrick classification system) whose skin colour prevents reliable clinical assessments
- •Any permanent (or transient within 28 days prior to dosing) disease (in particular cardiac disease such as heart failure or history of myocardial infarction) that may interfere with the subjects safe participation in the trial, with the subjects ability to participate in the trial or with the clinical assessments
- •Subjects with congenital or acquired immunodeficiencies or in subjects on therapy that causes immunosuppression
研究组 & 干预措施
LEO 39652 cream
Experimental
Topical application
干预措施: LEO 39652 cream (Drug)
LEO 39652 cream vehicle
Placebo Comparator
Topical application
干预措施: LEO 39652 cream (Drug)
结局指标
主要结局
Total sign score at end of treatment
时间窗: 22 days
Total Sign Score is defined as the sum of severity scores (4-point scale) of the Individual Sign Scores(erythema, edema/papulation, oozing/crusting, excoriations, lichenification and dryness)for each assessed area.
次要结局
- Total sign score on limited treatment area(22 days)
- Investigator's treatment area assessment of disease severity(22 days)
- Subject´s treatment area assessment of disease severity(22 days)
- Subject´s assessment of itching(22 days)
- Transepidermal Water Loss(22 days)
研究者
研究点 (1)
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