NCT01257919已完成1 期
Investigator-blinded, Randomized, Cross-over, Multiple Dose Phase I Study on Safety and Pharmacokinetics of Topically Applied Azelaic Acid Foam, 15% Compared to Azelaic Acid Gel, 15% in Subjects With Papulopustular Rosacea
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
- 21
- 试验地点
- 1
- 主要终点
- Baseline corrected area under the curve (AUC)
研究概览
简要总结
Assessment of pharmacokinetics of Azelaic Acid Foam after repeated skin application and in comparison to Azelaic Acid gel.
Assessment of safety after repeated skin application.
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
- Single (Investigator)
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
- •diagnosis of moderate papulopustular rosacea
- •free of any clinically significant disease
排除标准
- •body weight less than 50 or more than 130 kg
- •clinically significant disease which could interfere with the study
研究组 & 干预措施
Azelaic Acid Foam 15%
Experimental
Dermal application of Azelaic Acid Foam 15%
干预措施: Azelaic Acid Foam (Drug)
Azelaic Acid Gel 15%
Active Comparator
Dermal application of Azelaic Acid Gel 15%
干预措施: Azelaic Acid Gel (Drug)
结局指标
主要结局
Baseline corrected area under the curve (AUC)
时间窗: 12 hours
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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