NCT02496546已完成1 期
An Explorative Trial Evaluating the Effect of LEO 32731 Cream 20 mg/g 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 on entire treatment area
研究概览
简要总结
The aim of this trial is to assess the efficacy of LEO 32731 cream 20 mg/g compared with LEO 32731 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
- Male
- 接受健康志愿者
- 否
入选标准
- •Following verbal and written information about the trial, subjects must provide informed consent documented by signing the Informed Consent Form (ICF) prior to any trial related procedures being carried out
- •Subject with Atopic Dermatitis (AD) as defined by Hanifin and Rajka criteria and with mild to moderate disease severity (IGA 2 or 3) as assessed by a dermatologically trained investigator (and confirmed by a board certified dermatologist before or at visit 1)
- •Two symmetrically located and comparable Entire Treatment Areas (ETAs) of 20 - 50 cm2 each, i.e. on the same body region (left and right part) and of the same size (complete AD lesion or part of an AD lesion); Total Sign Score (TSS) of at least 5 on both ETAs; difference in TSS not greater than 2 between the two ETAs; sign score for erythema ≥ 2 on both ETAs; difference in Investigator´s Treatment Area assessment of disease severity not greater than 1 between the 2 ETAs
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
研究组 & 干预措施
LEO 32731 cream
Experimental
Topical application
干预措施: LEO 32731 cream (Drug)
LEO 32731 cream vehicle
Placebo Comparator
Topical application
干预措施: LEO 32731 cream vehicle (Drug)
结局指标
主要结局
Total sign score at end of treatment on entire treatment area
时间窗: 3 weeks
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 area
次要结局
- Total sign score on limited treatment area on entire treatment area during trial(3 week)
- Investigator's treatment area assessment of disease severity on entire treatment area during trial(3 weeks)
- Subject's treatment area assessment of disease severity on entire treatment area during trial(3 weeks)
- Subject's assessment of itching on entire treatment area during trial(3 weeks)
- Transepidermal water loss during trial(3 weeks)
- Individual signs score on entire treatment during trial(3 weeks)
研究者
研究点 (1)
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