A Randomized, Double-Blind, Placebo Controlled, Parallel Design, Multiple-Site Study to Evaluate the Clinical Equivalence of Two Butenafine Hydrochloride 1% Creams in Patients With Interdigital Tinea Pedis
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 548
- 试验地点
- 1
- 主要终点
- Therapeutic Cure - Superiority Analysis
研究概览
简要总结
To demonstrate comparable safety and efficacy of Taro Pharmaceuticals Inc. butenafine hydrochloride cream 1% (test product) and Lotrimin Ultra® cream (reference listed drug) in the treatment of interdigital tinea pedis, and to show the superiority of the active treatments over that of the placebo (vehicle).
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
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Microbiologically confirmed clinical diagnosis of interdigital tinea pedis
- •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, intra-uterine device (IUD), oral, transdermal, injected or implanted hormonal contraceptives).
- •A confirmed clinical diagnosis of interdigital tinea pedis. Lesions are to be predominately interdigital but may extend to other areas of the foot (the non-interdigital lesions must not be hyperkeratotic).
- •The presence of tinea pedis infection, confirmed by the observation of segmented fungal hyphae during a microscopic potassium hydroxide (KOH) wet mount examination (potassium hydroxide mount preparation).
- •Identification of an appropriate dermatophyte by culture sent to the central laboratory. The appropriate dermatophytes are Trichophyton rubrum, Trichophyton mentagrophyte or Epidermophyton floccosum.
排除标准
- •Use of any of the following within the indicated timeline:
- •Oral or injectable steroids
- •Any oral anti-fungals within 4 weeks of the study start
- •Use of topical corticosteroids or any other topical antipruritics on the feet within 72 hours of the study start.
- •Any prescription or over-the-counter (OTC) topical antifungals on the feet within two weeks prior to study entry
- •Use of any antihistamines within 72 hours of the study start.
- •Any known hypersensitivity to butenafine or other antifungal agents.
- •Evidence of any concurrent dermatophytic infection of toe nails (onychomycosis) or other dermatological condition of the foot that may interfere with the Investigator's evaluation of tinea pedis.
- •Patients with recurrent tinea pedis (more than 3 infections in the past 12 months) who have been unresponsive to previous antifungal therapy.
研究组 & 干预措施
Butenafine cream 1% (Taro)
Butenafine cream manufactured by Taro applied for 7 days
干预措施: Butenafine cream 1% manufactured by Taro (Drug)
Lotrimin Ultra (butenafine) 1%
Lotrimin Ultra (butenafine) applied for 7 days
干预措施: Lotrimin Ultra (butenafine) 1% (Drug)
Vehicle
Butenafine vehicle applied for 7 days
干预措施: Butenafine Vehicle manufactured by Taro (Drug)
结局指标
主要结局
Therapeutic Cure - Superiority Analysis
时间窗: 42 days
Therapeutic Cure requires both Clinical Cure and Mycological Cure. Clinical Cure was based on the following signs and symptoms: fissuring, erythema, maceration, vesiculation, scaling, exudation, pruritus, burning. Each clinical symptom was evaluated using a 0-3 point rating scale: none=0, mild=1, moderate=2 or severe=3. If the score for erythema was ≤ 2 and the sum for all of the other 7 signs and symptoms was \<2 then the patient was considered a Clinical Cure. Mycological Cure: The potassium hydroxide (KOH) and the fungal culture were both negative.
Therapeutic Cure Non-Inferiority Comparison of Butenafine Cream and Lotrimin Ultra
时间窗: 42 days
Patient was cured both by symptoms (Clinical Cure) and by the results of fungal testing (Mycological Cure).
次要结局
- Therapeutic Cure(7 days)
- Mycologic Cure(42 days)
- Clinical Cure(42 days)
- Safety and Adverse Event Profile(42 days)