NCT02132260已完成1 期
A Multicenter, Double-blind, Randomized, Parallel-group, Placebo-controlled Study to Evaluate the Safety and Efficacy of a Naftifine Hydrochloride Cream 2%and the Naftin® Cream 2% in Patients With 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
- 890
- 主要终点
- Therapeutic Cure
研究概览
简要总结
The objective of this study is to compare the efficacy and safety of the test formulation of Naftifine Hydrochloride Cream 2% to Naftin® (Naftifine Hydrochloride) 2% Cream in a 6 week study 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
- Double (Participant, Investigator)
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
- •Male or non-pregnant, non-lactating females 18 years or older
- •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 presence of interdigital tinea pedis infection
- •The sum of the clinical signs and symptoms scores of the target lesion is at least 4, including a minimum score of at least 2 for erythema and a minimum score of 2 for either scaling or pruritus
排除标准
- •Females who are pregnant, lactating or planning to become pregnant during the study period
- •Use of antipruritics, including antihistamines within 72 hours prior to baseline visit
- •Use of topical corticosteroids, antibiotics or antifungal therapies within two weeks prior to baseline visit
- •Use of systemic corticosteroids, antibiotics or antifungal therapies within one month prior to baseline visit
- •Use of oral terbinafine or itraconazole within two months prior to baseline visit
- •Use of immunosuppressive medication or radiation therapy within three months prior to baseline visit
- •Any known hypersensitivity to Naftifine Hydrochloride, or any component of the formulation
- •Confluent, diffuse moccasin-type tinea pedis of the entire plantar surface
- •History of significant or current evidence of chronic infectious disease, system disorder, organ disorder, or other medical condition that would place undue risk by participation or could jeopardize the integrity of study evaluations
- •Evidence of any concurrent dermatophytic infection of the toe nails or dermatological condition of the foot that may interfere with tinea pedis evaluation
- •Past history of dermatophyte infections with a lack of response ot antifungal therapy
研究组 & 干预措施
Naftifine Hydrochloride Cream 2%
Experimental
Naftifine Hydrochloride Cream 2% (Taro Pharmaceuticals Inc.)
干预措施: Naftifine Hydrochloride Cream 2% (Drug)
Naftin® Cream 2%
Active Comparator
Naftin® (Naftifine Hydrochloride) Cream 2%
干预措施: Naftin® (Naftifine Hydrochloride) Cream 2% (Drug)
Placebo Topical Cream
Placebo Comparator
Placebo Topical Cream
干预措施: Placebo Topical Cream (Drug)
结局指标
主要结局
Therapeutic Cure
时间窗: 6 weeks
The proportion of subjects with therapeutic cure (both mycological cure and clinical cure) at the test-of-cure visit conducted four weeks after the end of treatment.
次要结局
未报告次要终点
研究者
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