A Randomized, Prospective Multicenter, Double Blind, Parallel Assignment Placebo Controlled BE Study Of Naftifine Hydrochloride 2% Topical Cream With Naftin® In Patients With Tinea Pedis Using Clinical Endpoints
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 693
- 试验地点
- 13
- 主要终点
- Mycological cure and clinical cure for a single target lesion for Trichyphyton rubrum
研究概览
简要总结
The current study was randomized, double blind, placebo-controlled, prospective, multicenter, comparative therapeutic equivalence study.
The study duration for each patient was 6 weeks: Following were the visit details.
V1-Baseline and Randomization Visit (Day 1). V2- End of therapy visit (at the end of week 2 + 2 days). V3- Follow up visit (at the end of week 4 + 2 days). V4 - Test of cure visit ( at the end of week 6 + 4 days).
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
- •Healthy males and females aged more than or equal to 18 years
- •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), and provisionally confirmed at baseline by a positive potassium hydroxide (KOH) wet mount preparation (i.e., skin scrapings from the target site are placed on a microscope slide with a drop of 10% KOH, and microscopic examination reveals segmented fungal hyphae)
- •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 (on a scale of 0-3, where 2 indicates moderate severity)
排除标准
- •Pregnant or lactating or planning to become pregnant during the study period
- •Use of antipruritics, including antihistamines, within 72 hours prior to entry into the study
- •Use of topical corticosteroid, antibiotics or antifungal therapy within 2 weeks prior to entry into the study
- •Use of systemic (e.g., oral or injectable) corticosteroid, antibiotics or antifungal therapy within 1 month prior to entry into the study
- •Use of oral terbinafine or itraconazole within 2 months prior to entry into the study
- •Use of immunosuppressive medication or radiation therapy within 3 months prior to entry into the study.
- •Confluent, diffuse moccasin-type tinea pedis of the entire plantar surface.
- •Presence of any other infection of the foot or other disease process that might confound the treatment evaluation
- •History of dermatophyte infections unresponsive to systemic or topical antifungal drugs
- •Known hypersensitivity to Naftifine Hydrochloride or to any component of the formulation
研究组 & 干预措施
Naftifine hydrochloride 2%
A thin layer of sufficient quantity of Naftifine hydrochloride cream need to be applied to the affected areas plus an approximate ½ inch margin of healthy surrounding skin once daily consecutively for 2 weeks.
干预措施: Naftifine hydrochloride 2% (Drug)
Naftin® 2% (Naftifine hydrochloride 2%)
A thin layer of sufficient quantity of Naftifine hydrochloride cream need to be applied to the affected areas plus an approximate ½ inch margin of healthy surrounding skin once daily consecutively for 2 weeks.
干预措施: Naftin® 2% (Naftifine hydrochloride 2%) (Drug)
Placebo vehicle cream.
A thin layer of sufficient quantity of vehicle cream need to be applied to the affected areas plus an approximate ½ inch margin of healthy surrounding skin once daily consecutively for 2 weeks.
干预措施: Placebo (Drug)
结局指标
主要结局
Mycological cure and clinical cure for a single target lesion for Trichyphyton rubrum
时间窗: week 6 + 4 days
After 6 weeks the skin scrapping will be collected for culture to find out the growth of T rubrum. Absence of growth suggests complete cure.
次要结局
- Mycological cure and clinical cure for Trichophyton rubrum, Trichophyton mentagrophytes, or Epidermophyton floccosum(week 6 + 4 days)