NCT01519752已完成1 期
A Randomized, Double-Blind, Placebo Controlled, Parallel Design, Multiple-Site, Study Comparing Oxiconazole Nitrate Cream 1% (Taro Pharmaceuticals,Inc) to Oxistat® (Oxiconazole Nitrate Cream) Cream 1% (PharmaDerma) in the Treatment of Tinea Pedis
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 661
- 主要终点
- Therapeutic Cure
研究概览
简要总结
The objective of this study is to demonstrate that Oxiconazole nitrate 1% topical cream is effective for the treatment of patients with moderate to severe 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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or non-pregnant, non-lactating female, 12 years of age or older.
- •Signed informed consent form, which meets all criteria of current FDA regulations
- •If female and of child bearing potential, prepare to abstain from sexual intercourse or use a reliable method of contraception during the study {e.g., condom, IUD, oral, transdermal, injected or implanted hormonal contraceptives)and (must have used the same product for at least 30 days prior to the study start and use the same product throughout the duration of the study), transdermal or implanted hormonal contraceptives}
- •A confirmed 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 moccasin).
- •The presence of tinea pedis infection, confirm by the observation of segmented fungal hyphae during a microscopic KOH wet mount examination.
排除标准
- •Females who are pregnant, or lactating or likely to become pregnant during the study.
- •Any known hypersensitivity to oxiconazole nitrate or other antifungal agents.
- •Patients with a past history of tinea pedis infections with a lack of response to antifungal therapy (i.e. recurrent tinea pedis, more than 3 infections in the past 12 months, which were unresponsive to previous antifungal therapy).
- •Participation in a research study in the past 30 days prior to screening/randomization.
研究组 & 干预措施
Oxiconazole Nitrate Cream 1%
Experimental
干预措施: Oxiconazole Nitrate Cream 1% (Drug)
Oxiconazole Nitrate Cream 1% (Oxistat®)
Active Comparator
干预措施: Oxiconazole Nitrate Cream 1% (Oxistat®) (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Therapeutic Cure
时间窗: Day 42
Clinical \& Mycological Cure at 6 weeks
次要结局
- Clinical Cure(Day 42)
- Mycological Cure(Day 42)
研究者
相似试验
已完成
1 期
A Therapeutic Equivalence Study of Two Metronidazole 1%Topical Gel Treatments for Patients With RosaceaRosaceaNCT01513863Taro Pharmaceuticals USA602
已完成
3 期
Non-inferiority Trial of Dapaconazole Versus KetoconazoleTinea PedisNCT03320486Biolab Sanus Farmaceutica360
已完成
3 期
Comparative Efficacy of Bifonazole Cream vs Placebo After Nail Ablation With Urea PasteOnychomycosisNCT00781820Bayer693
已完成
3 期
Clinical Trial of Anusol Ointment for Symptom Relief in Patients With HaemorrhoidsHemorrhoidsNCT05157711Church & Dwight Company, Inc.66
已完成
3 期
Therapeutic Equivalence and Safety of Two Econazole Nitrate Cream, 1% Products in Tinea PedisTinea PedisNCT03129321Mylan Inc.876