NCT02385318已完成3 期
To Compare Safety and Efficacy of Perrigo's Drug Product Compared to an FDA Approved Drug Product in the Treatment of Actinic Keratosis
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Padagis LLC
- 入组人数
- 519
- 主要终点
- Number of Participants With Complete Clearance (Absence) of Actinic Keratosis Lesions as Determined by Visual Inspection of the Investigator
研究概览
简要总结
The purpose of this study is to compare safety and efficacy of Perrigo's drug product compared to an FDA approved drug product in the treatment of actinic keratosis.
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
- Double (Participant, 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Test Product
Experimental
Ingenol Mebutate
干预措施: Ingenol Mebutate (Perrigo) (Drug)
Reference product
Active Comparator
Ingenol Mebutate
干预措施: Ingenol Mebutate (Reference) (Drug)
Placebo product
Placebo Comparator
Placebo gel
干预措施: Placebo gel (Drug)
结局指标
主要结局
Number of Participants With Complete Clearance (Absence) of Actinic Keratosis Lesions as Determined by Visual Inspection of the Investigator
时间窗: Day 57
次要结局
未报告次要终点
研究者
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