A Double-blind, Randomized, Parallel-group, Vehicle-controlled, Multi-center Study to Evaluate the Safety and Clinical Equivalence of a Generic Ciclopirox Olamine Topical Suspension to Reference Ciclopirox Topical Suspension 0.77% in the Treatment of Tinea Pedis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Padagis LLC
- 入组人数
- 553
- 主要终点
- Proportion of Subjects in Each Treatment Group With Therapeutic Success
研究概览
简要总结
The objectives of this study were to demonstrate comparable safety and efficacy of Ciclopirox Olamine Topical Suspension (Test Product) and Ciclopirox Topical Suspension 0.77% (Reference Product) in the treatment of subjects with tinea pedis, and to show the superiority of the active treatments over that of the vehicle.
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
- 10 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female at least 10 years of age, and otherwise healthy
- •Clinically and mycologically confirmed diagnosis of symptomatic tinea pedis
- •In good health with no clinically significant disease that might have interfered with study evaluations
- •Study participant or legal guardian was willing and able to read and sign an IRB approved ICF, which included agreement to comply with all study requirements as indicated in the protocol. For subjects 10 to 17 years of age, an assent form for minors was completed.
排除标准
- •History of hypersensitivity or allergy to ciclopirox
- •Had any skin condition that would interfere with the diagnosis or assessment of tinea pedis
- •Had a history of dermatophyte infection unresponsive to antifungal treatment
- •Had a history of alcoholism, drug abuse, or problems that would likely have made the subject unreliable for the study
- •Had any condition or used any medication that, in the opinion of the Investigator, might have interfered with the conduct or results of the study or placed the prospective subject at increased risk
- •Was unwilling to sign the informed consent
- •Female who was pregnant or lactating
研究组 & 干预措施
Test Product
Ciclopirox Olamine Topical Suspension
干预措施: Ciclopirox Olamine Topical Suspension (Drug)
Reference Product
Loprox® Topical Suspension 0.77%
干预措施: Ciclopirox Topical Suspension 0.77%-Reference Product (Drug)
Vehicle Product
placebo of test product
干预措施: Ciclopirox Olamine Topical Suspension-Placebo (Drug)
结局指标
主要结局
Proportion of Subjects in Each Treatment Group With Therapeutic Success
时间窗: 6 weeks
Therapeutic success was defined as having both Mycological Cure (potassium hydroxide \[KOH\] wet mount negative and fungal culture negative) and Clinical Cure
次要结局
- Proportion of Subjects With Mycological Cure(6 weeks)
- Proportion of Subjects With Clinical Cure(6 weeks)