A Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel Group Study of the Efficacy and Safety of Terbinafine Film Forming Solution, 1% (as Hydrochloride), in Patients With Tinea Pedis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 290
- 试验地点
- 6
- 主要终点
- Effective Treatment Outcome (Direct Microscopy and Culture Negative and Total Signs and Symptom Score Less or Equal to 2)
研究概览
简要总结
This study will compare the efficacy and safety of a single dose of terbinafine film forming solution 1% with a single dose of placebo film forming solution in the treatment of 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
- •Patients ≥18 years of age with interdigital tinea pedis infection, with clinical diagnosis meeting required baseline total sign & symptom score and positive microscopy
排除标准
- •Allergy to the allylamine class of antimycotics or excipients in the formulation.
- •Chronic, hyperkeratotic plantar (moccasin) tinea pedis
- •Other fungal disease or intertrigo
- •Other abnormal findings on the affected foot
- •Systemic antifungal or antimicrobial treatment within the last 3 months
- •Topical treatment for skin lesions on feet within the last 3 months
- •Diabetes mellitus and peripheral artery occlusive disease
研究组 & 干预措施
Terbinafine
Drug
干预措施: Terbinafine (Drug)
Placebo
Drug
干预措施: Terbinafine Placebo (Drug)
结局指标
主要结局
Effective Treatment Outcome (Direct Microscopy and Culture Negative and Total Signs and Symptom Score Less or Equal to 2)
时间窗: week 6
Each clinical sign or symptom will be assessed separately. The investigator will evaluate the severity of each sign or symptom over the entire target foot. Clinical signs and symptoms including desquamation (scaling), erythema, incrustation (crusting), pustules, vesiculation and pruritus will be evaluated by the investigator or designee and recorded at every visit using the following scale: 0 = absent 1. = mild 2. = moderate 3. = severe In order to calculate the total symptoms score the rating for all symptoms are added up. Possible range 0 to 18
次要结局
- Total Clinical Signs and Symptoms (S/S) Scores(week 6)
- Number of Subjects With Adverse Event(6 weeks)