A Multi-Center, Double-Blind, Randomized, Parallel-Group, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Naftifine Hydrochloride Gel 2% and Naftin® (Naftifine Hydrochloride) Gel 2% in Patients With Tinea Pedis.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 1,519
- 主要终点
- Therapeutic cure after end of treatment
研究概览
简要总结
To compare the efficacy and safety of the test formulation Naftifine Hydrochloride Gel 2% to Naftin® (Naftifine Hydrochloride) Gel 2%
详细描述
The purpose of this study is to compare the efficacy and safety of the test formulation Naftifine Hydrochloride Gel 2% to Naftin® (Naftifine Hydrochloride) Gel 2% in a six week study (four weeks after the end of two week treatment) 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
- •Male or non-pregnant, non-lactating females 18 years of age or older.
- •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.
- •Clinical diagnosis of interdigital 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, confirmed by the observation of segmented fungal hyphae during a microscopic potassium hydroxide wet mount preparation.
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 2 weeks prior to baseline visit.
- •Use of systemic corticosteroids, antibiotics or antifungal therapies within 1 month prior to baseline visit.
- •Use of oral Terbinafine or Itraconazole within 2 months prior to baseline visit.
- •Use of immunosuppressive medication or radiation therapy within 3 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 patient at undue risk by participation or could jeopardize the integrity of the study evaluations.
- •Evidence of any concurrent dermatophytic infection of the toe nails or dermatological condition of the foot that may interfere with the investigator's evaluation of tinea pedis.
- •Patients with a past history of dermatophyte infections with a lack of response to antifungal therapy.
研究组 & 干预措施
Naftifine Hydrochloride Gel 2%
Naftifine Hydrochloride Gel 2% (Taro Pharmaceuticals Inc.)
干预措施: Naftifine Hydrochloride Gel 2% (Drug)
Naftin® Gel 2%
Naftin® (Naftifine Hydrochloride) Gel 2% (Merz Pharmaceuticals, LLC)
干预措施: Naftin® Gel 2% (Drug)
Placebo Topical Gel
Placebo Topical Gel (Taro Pharmaceuticals Inc.)
干预措施: Placebo Topical Gel (Drug)
结局指标
主要结局
Therapeutic cure after end of treatment
时间窗: Study day 38-46
The proportion of subjects with therapeutic cure, defined as both mycological cure and clinical cure, at the test-of-cure visit conducted four weeks after the end of treatment (study day 38-46).
次要结局
未报告次要终点