Skin Irritation Trial of LEO 90100 Foam (Calcipotriol Hydrate Plus Betamethasone Dipropionate) in Healthy Japanese Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- LEO Pharma
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Skin irritation
研究概览
简要总结
This trial is looking at whether the LEO 90100 foam causes irritation of the skin in healthy Japanese male adults without psoriasis. A single application of LEO 90100 foam and its vehicle will each be made to 2 body sites in 20 subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Signed informed consent has been obtained.
- •Healthy Japanese male subjects.
- •Aged 20 to 40 years inclusive.
排除标准
- •Body Mass Index outside the range 18-25 kg/m²
- •Use of any medication (systemic or topical) within 2 weeks of Day 1.
研究组 & 干预措施
LEO 90100 foam
Each subject has each of the 2 investigational products applied at the same time on 2 sites on the back. The location on which the treatments are applied is randomised in a double-blinded manner LEO 90100 foam contains Calcipotriol hydrate 52.2 μg/g (equivalent to 50.0 μg/g calcipotriol) plus Betamethasone dipropionate 0.643 mg/g
干预措施: LEO 90100 foam (Drug)
Vehicle foam
Each subject has each of the 2 investigational products applied at the same time on 2 sites on the back. The location on which the treatments are applied is randomised in a double-blinded manner.
Foam vehicle does not contain active ingredients
干预措施: Vehicle of LEO 90100 foam (Drug)
结局指标
主要结局
Skin irritation
时间窗: Up to Day 4
Skin irritation measured as skin irritation index (summation of clinical scores \[ranging from no reaction to blisters\] from 49 hrs to 72 hrs after aplication) divided by total number of skin irritation assessments
Photo irritation
时间窗: Up to Day 4
Positive ratios calculated from the photo irritation scores
次要结局
未报告次要终点