Efficacy and Safety of Efinaconazole 10% Solution in the Treatment of Onychomycosis in Diabetic Patients
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Primary Endpoint - Efficacy
研究概览
简要总结
Onychomycosis, a common pathology of the toenails, is even more prevalent among diabetic subjects. Nearly 26 million Americans suffer from diabetes, and approximately one-third of subjects with diabetes have toenail onychomycosis. Numerous studies have addressed the efficacy and safety of both topical and oral antifungal treatment options for onychomycosis in diabetic subjects. However, no study to date has specifically addressed the efficacy and safety of efinaconazole among diabetic subjects.
The objective of this noncomparative, uncontrolled study is to determine the efficacy of topical efinaconazole 10% for toenail onychomycosis among subjects with diabetes mellitus. Specific indicators to measure efficacy of treatment will be the mycological cure rate, complete cure rate, and treatment success. Furthermore, an additional goal of the study is to gain knowledge of safety in the setting of a cohort of diabetic subjects
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Clinical diagnosis of onychomycosis confirmed through positive KOH stain or positive mycologic culture findings.
- •Involvement of at minimum 20% of the target great toenail.
排除标准
- •Diagnosis of a nondermatophyte fungus infection, diagnosis of proximal subungual onychomycosis, diagnosis of superficial white onychomycosis
- •Diagnosis of peripheral arterial disease or anatomic abnormalities of the target toenail
- •Inability to follow through with all requisite office visits
- •Routine use of a systemic corticosteroid, routine use of a systemic immunomodulator, or history of systemic antifungals within the prior five years.
- •Active interdigital tinea pedis refractory to topical antifungal treatments
- •Known hypersensitivity to efinaconazole
- •Use, within the month preceding screening, of: topical antifungal agents, topical anti-inflammatory agents to the toes
- •Any history of oral systemic antifungal with known activity against dermatophytes
研究组 & 干预措施
Intervention Group, receiving medication
Enrolled subjects with confirmed onychomycosis will be dispensed topical medication for treatment.
干预措施: Efinaconazole Topical (Drug)
结局指标
主要结局
Primary Endpoint - Efficacy
时间窗: 50 weeks
The primary efficacy end point is the proportion of subjects achieving complete cure at week 50. Complete cure is to be defined as a combination of 0% clinical involvement and mycological cure (mycological cure defined as negative KOH examination and negative fungal culture of the target toenail sample).
次要结局
- Secondary Endpoint - Efficacy(50 weeks)
- Secondary Endpoint - Safety (Occurrence of Adverse Events: Type and Frequency)(50 weeks)