NCT01302119已完成3 期
A Randomized, Double-Blind, Vehicle-Controlled, Multi-Center Study to Evaluate the Efficacy and Safety of AN2690 Topical Solution, 5%, vs. Solution Vehicle in the Treatment of Onychomycosis of the Toenail in Adults
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
- Pfizer
- 入组人数
- 604
- 试验地点
- 1
- 主要终点
- Complete Cure (Completely Clear Nail and Negative Mycology) of Target Great Toenail at Week 52
研究概览
简要总结
The purpose of this study is to determine whether AN2690 topical solution is a safe and effective treatment for onychomycosis of the toenail.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Clinical diagnosis of distal subungual onychomycosis affecting at least one great toenail
- •KOH positive at screening
- •Willingness not to use any other products including nail polish applied to the toenails during the study
- •Women of childbearing potential who are currently sexually active must agree to use contraception for the entire study period
排除标准
- •Concurrent or recent use of certain topical or systemic medications without a sufficient washout period
- •History of any significant chronic fungal disease other than onychomycosis
- •Significant confounding conditions as assessed by study doctor
- •Participated in any other trial of an investigational drug or device within 30 days or participation in a research study concurrent with this study
- •Pregnancy or lactation
研究组 & 干预措施
AN2690 Topical Solution, 5%
Experimental
AN2690 Topical Solution, 5%
干预措施: AN2690 Topical Solution, 5% (Drug)
Solution Vehicle
Placebo Comparator
Solution Vehicle
干预措施: Solution Vehicle (Drug)
结局指标
主要结局
Complete Cure (Completely Clear Nail and Negative Mycology) of Target Great Toenail at Week 52
时间窗: Week 52
No clinical evidence of onychomycosis as evidenced by normal toenail plate, no onycholysis, and no subungual hyperkeratosis, and negative KOH wet mount and negative fungal culture.
次要结局
- Completely Clear or Almost Clear Target Great Toenail at Week 52(Week 52)
- Treatment Success (Completely Clear or Almost Clear Nail and Negative Mycology) of Target Great Toenail at Week 52(Week 52)
- Negative Mycology of Target Great Toenail at Week 52(Week 52)
研究者
研究点 (1)
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