NCT03116698已完成2 期
A Multi-Center, Randomized, Double-Blind, Parallel-Group, Vehicle-Controlled Study to Evaluate the Dose-Response Relationship of the Efficacy and Safety of Two Concentrations of DFD-07 Cream, in Subjects With Actinic Keratosis (AK) of the Face and/or Scalp Over a 12-week Treatment Period.
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 240
- 试验地点
- 20
- 主要终点
- Proportion of Subjects With Complete Clearance of AK Lesions at the End of Study Visit at 16 Weeks
研究概览
简要总结
Once or twice daily 12 week treatment in patients with Actinic Keratosis randomized to treatment in one of four arms.
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 65 Years（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
Low dose DFD07 once daily
Experimental
干预措施: Low dose DFD07 once daily (Drug)
High dose DFD07 once daily
Experimental
干预措施: High dose DFD07 once daily (Drug)
High dose DFD07 twice daily
Experimental
干预措施: High dose DFD07 twice daily (Drug)
Placebo twice daily
Placebo Comparator
干预措施: Placebo twice daily (Drug)
结局指标
主要结局
Proportion of Subjects With Complete Clearance of AK Lesions at the End of Study Visit at 16 Weeks
时间窗: 16 Weeks
The proportion of subjects with complete clearance (absence of clinically visible or palpable AK lesions in the treatment area) of AK lesions at the End of Study Visit at 16 weeks (12 weeks treatment and 4 weeks treatment-free follow-up)
次要结局
- Proportion of Subjects With Partial Clearance at Week 16(16 weeks)
研究者
研究点 (20)
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