Dermatopharmacokinetic Trial of LEO 90100 Foam
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- LEO Pharma
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- The amount of each of the 2 active ingredients, calcipotriol and betamethasone dipropionate, in the stratum corneum obtained by means of tape stripping after application of LEO 90100 foam and Dovobet® ointment.
研究概览
简要总结
This is a phase 1, single centre trial in Japanese healthy male subjects comparing the amount of active ingredients of LEO 90100 foam and Dovobet® ointment in the stratum corneum.
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
- None
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
- •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
LEO 90100 foam (containing calcipotriol hydrate 52.2 µg/g [equivalent to 50.0 µg/g calcipotriol] plus betamethasone dipropionate 0.643 mg/g).
Pilot part: 6 single applications of LEO 90100 foam on Day 1 (for 12 sites in total).
Pivotal part: To be decided based on the result of the pilot part
干预措施: LEO 90100 foam (Drug)
Dovobet® ointment
Pilot part: 6 single applications of Dovobet® ointment on Day 1 (for 12 sites in total).
Pivotal part: To be decided based on the result of the pilot part
干预措施: Dovobet® ointment (Drug)
结局指标
主要结局
The amount of each of the 2 active ingredients, calcipotriol and betamethasone dipropionate, in the stratum corneum obtained by means of tape stripping after application of LEO 90100 foam and Dovobet® ointment.
时间窗: 2, 4, 6, 8, 12 and 24 hr after drug application.
Amount (nanogram) of calcipotriol and betamethasone dipropionate in the stratum corneum will be compared between the two formulations by selected time points using an ANOVA model with treatment/formulation as systematic effect.
次要结局
- Safety data - number of adverse events(up to 15 Days after drug application)