EFFICACY AND SAFETY OF A SINGLE-APPLICATION TREATMENT USING TERBINAFINE HYDROCHLORIDE (1%) TOPICAL LIQUID SOLUTION VERSUS A SINGLE-APPLICATION TREATMENT USING BUTENAFINE HYDROCHLORIDE (1%) TOPICAL LIQUID SOLUTION FOR THE TREATMENT OF TINEA PEDIS: A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Proportion of participants with effective treatment at week 6
研究概览
简要总结
Tinea pedis or athlete's foot is the most common fungal infection worldwide, caused by infection of the feet with dermatophytes such as Trichophyton rubrum, Trichophyton interdigitale (formerly Trichophyton mentagrophytes), and Epidermophyton floccosum. Diagnosis of tinea pedia involves clinical symptoms as well as microscopic examination. Topical therapies are usually applied once or twice daily for as long as 4 weeks, posing a challenge to compliance. The current study aims to test a formulation of the single-dose 1% terbinafine hydrochloride, as well as a single-dose 1% butenafine hydrochloride, versus a vehicle control in adult Filipino patients with athlete's foot. This study will benefit the Filipino community by helping us determine which anti-fungal cream is most effective for athlete's foot.
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, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or nonpregnant females aged 18-60 years old.
- •Clinical diagnosis of tinea pedis (total sign/symptom score >2), lesions between the toes, with possible extension to the lateral surfaces and soles of the feet confirmed by a positive microscopy prior to dosing.
- •Willing to sign the informed consent.
排除标准
- •Females who are pregnant (confirmed by a pregnancy test), suspect themselves to be pregnant (even if pregnancy test is negative), breast-feeding, or planning a pregnancy.
- •Signs of systemic or other superficial fungal disease (e.g.onychomycosis), clinically relevant abnormal findings upon physical examination of the foot or previous treatment with a disallowed medication (such as corticosteroids).
- •Presence of non-healing wounds and/or bacterial infection on the feet.
- •Secondary bacterial infection due to tinea pedis
- •Presence of pigmentation, extensive scarring, or pigmented lesions in the treatment areas, which could interfere with the rating of efficacy parameters.
- •History of hypersensitivity to any component of the test products.
- •Current imuunosuppression. Specifically, these include patients with co-morbidities such as diabetes, HIV, chronic diseases requiring maintenance medications, acute febrile/infectious illnesses (i.e. Dengue, pneumonia, etc)
- •Use within 3 months prior to baseline of: 1.) chemotherapy, or 2.) radiation therapy
研究组 & 干预措施
Treatment # 1
干预措施: TERBINAFINE HYDROCHLORIDE (1%) (Drug)
Treatment # 2
干预措施: BUTENAFINE HYDROCHLORIDE (1%) (Drug)
Placebo Control
干预措施: Vehicle Control (Drug)
结局指标
主要结局
Proportion of participants with effective treatment at week 6
时间窗: 6 weeks
Defined as negative microscopy and improvement in signs and symptoms: mild or no erythema, desquamation or pruritis (\<=1), no vesiculation, and a total sign/symptom score of \<=2.
次要结局
未报告次要终点