Clinical Study to Evaluate the Therapeutic Equivalence and Safety of Econazole Nitrate Cream, 1% (Renaissance Pharma, Inc.) to Econazole Nitrate Cream, 1% (Perrigo New York Inc.) in Tinea Pedis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Mylan Inc.
- 入组人数
- 876
- 主要终点
- Proportion of Patients in Each Active Treatment Group Who Are Considered a Therapeutic Cure
研究概览
简要总结
To evaluate the therapeutic equivalence of the Test formulation, econazole nitrate cream, 1% to the Reference product, econazole nitrate cream, 1% in the treatment of tinea pedis.
To demonstrate the superiority of the Test and Reference (active) treatments over Placebo treatment in patients with tinea pedis.
To compare the safety of Test, Reference and Placebo treatments in patients with tinea pedis.
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
- •Healthy male or non-pregnant, non-lactating female ≥ 18 years of age.
- •Clinical diagnosis of tinea pedis with lesions localized to the interdigital spaces or predominantly interdigital, but may extend to other areas of the foot (the non-interdigital lesions should not be hyperkeratotic, i.e., characteristic of tinea pedis moccasin).
- •Provisionally confirmed at baseline by a positive potassium hydroxide (KOH) wet mount preparation
- •Total score ≥ 4 for the clinical signs and symptoms of tinea pedis in the target area. In addition the target area must have a minimum score of at least 2 for erythema and a minimum score of at least 2 for either pruritus or scaling.
排除标准
- •Presence of any other infection of the foot or other disease process that, in the Investigator's opinion, may interfere with the evaluation of the patient's tinea pedis
- •History of or current psoriasis, Lichen planus or contact dermatitis involving the feet within the previous 12 months.
- •Past history of dermatophyte infections with a lack of response to antifungal therapy
- •Confluent, diffuse moccasin-type tinea pedis of the entire plantar surface or onychomycosis involving ≥ 20% of the area of either great toenail and/or involving more than five toenails in total or other concurrent dermatophytoses (e.g., tinea cruris) and any other skin disease to an extent that, in the opinion of the investigator, might interfere with the evaluation of tinea pedis or study results
研究组 & 干预措施
Placebo
Placebo Cream, topical, sufficient amount to cover all affected areas on the feet once daily for 28 days
干预措施: Placebo (Drug)
Test
Econazole Nitrate Cream, 1%, topical, sufficient amount to cover all affected areas on the feet once daily for 28 days
干预措施: Econazole Nitrate Cream, 1% (Drug)
Reference Standard
Econazole Nitrate Cream, 1%, topical, sufficient amount to cover all affected areas on the feet once daily for 28 days
干预措施: Econazole Nitrate Cream, 1% (Drug)
结局指标
主要结局
Proportion of Patients in Each Active Treatment Group Who Are Considered a Therapeutic Cure
时间窗: Day 42
To be considered a Therapeutic Cure, the patient must have both Clinical Cure (patient's total severity score must be ≤ 2 with no individual severity score \> 1) and Mycological Cure (patient must have a negative KOH test and a negative fungal culture) of tinea pedis
Proportion of Patients in Each Treatment Group Who Are Considered a Therapeutic Cure
时间窗: Day 42
To be considered a Therapeutic Cure, the patient must have both Clinical Cure (patient's total severity score must be ≤ 2 with no individual severity score \> 1) and Mycological Cure (patient must have a negative KOH test and a negative fungal culture) of tinea pedis
次要结局
- Proportion of Patients in Each Active Treatment Group Who Are Considered a Clinical Cure (Patient's Total Severity Score Must be ≤ 2 With no Individual Severity Score > 1)(Day 42)
- Proportion of Patients in Each Active Treatment Group Who Are Considered a Mycological Cure(Day 42)
- Proportion of Patients in Each Treatment Group Who Are Considered a Clinical Cure (Patient's Total Severity Score Must be ≤ 2 With no Individual Severity Score > 1)(Day 42)
- Proportion of Patients in Each Treatment Group Who Are Considered a Mycological Cure(Day 42)