Clinical Study to Assess Tolnaftate 1% With a Novel Vehicle for the Treatment of Tinea Pedis
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Percentage of Subjects with a Complete Cure at Week 4
研究概览
简要总结
This study is designed to evaluate the safety and effectiveness of multiple 1% tolnaftate formulations delivered through novel stick-based vehicles in individuals with tinea pedis (athlete's foot).
详细描述
To evaluate the efficacy and safety of 1% tolnaftate formulations delivered through novel stick-based vehicles in the treatment of subjects with potassium hydroxide (KOH)-positive tinea pedis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female, aged 16 or above
- •Clinical diagnosis of tinea pedis (For Cohort 4, positive symptomology is acceptable)
- •Confirmation of diagnosis with positive potassium hydroxide (KOH) microscopy (For Cohort 4, a negative KOH test is acceptable)
- •Signed and dated informed consent form
- •Willingness to comply with study protocol and availability for the duration of the study
排除标准
- •Diagnosis of moccasin-type tinea pedis
- •Presence of serous exudate or pus
- •Treatment with a topical antifungal in the past 2 weeks
- •Treatment with a systemic antifungal in the past 4 weeks
- •Concurrent immunosuppressive or antimicrobial therapy
- •Liver disease
- •Pregnancy or breastfeeding
- •Use any other antifungal therapy during trial or within three months of starting the trial
- •Known hypersensitivity to any ingredients of trial agents
- •Patients with a current diagnosis of diabetes or neuropathy
研究组 & 干预措施
Tolnaftate Stick Formula A
Participants will receive Formula A, a topical 1% tolnaftate formulation delivered through a stick-based applicator. The product is applied twice daily for four weeks.
干预措施: 1% Tolnaftate Stick Formula A (Drug)
Tolnaftate Stick Formula B
Participants will receive Formula B, a topical 1% tolnaftate formulation delivered through a stick-based applicator. The product is applied twice daily for four weeks.
干预措施: 1% Tolnaftate Stick Formula B (Drug)
Tolnaftate Stick Formula C
Topical antifungal stick containing 1% tolnaftate in the Formula C base. Applied twice daily for 4 weeks.
干预措施: 1% Tolnaftate Stick Formula C (Drug)
结局指标
主要结局
Percentage of Subjects with a Complete Cure at Week 4
时间窗: Week 4
Primary Efficacy Endpoint: Effective treatment, defined as mycological cure, based on a negative potassium hydroxide (KOH) test at week 4.
次要结局
未报告次要终点