Phase IIB Efficacy and Safety Study of Four Topical Gel Formulations of Anti-Fungal Agents, MQX-5858, MQX-5859, MQX-5866, and MQX-5867, Versus Vehicle in the Treatment of Tinea Unguium.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 75
- 试验地点
- 10
- 主要终点
- Quanitative improvement in toenail appearance.
研究概览
简要总结
The purpose of this study is to compare, in a controlled fashion, the response to two anti-fungal agents, naftifine or terbinafine, with vehicle in novel topical gel formulations in the treatment of subjects with distal subungual tinea unguium of the toenails (onychomycosis).
The formulation used as the vehicle for the active agents has been shown in earlier studies to facilitate the penetration of the active agent through fungally-infected nails. This study will examine dose-response and agent differences in terms of efficacy and safety.
Once the subject has qualified for the study, he/she will be randomly assigned to one of five study groups, dispensed appropriate study medication and instructed to apply one drop to the great toe designated for study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •clinical diagnosis of distal subungual tinuea unguium of one great toenail.
- •between 20 - 65% infected area for target nail
- •2 mm of clear nail proximally on target nail
- •positive dermatophyte culture and positive KOH test
- •able to sign informed consent
- •understand requirements of study
- •females must be post-menopausal or agree to use approved contraceptives throughout the study
排除标准
- •patients with nails infected with organisms other than dermatophytes
- •patients with proximal subungual tinea unguium
- •patients with spikes of disease extending to nail matrix
- •patients with more than 5 infected nails
- •patients with confounding problems/ abnormalities of target nail
- •patients with screening lab values more than 20% of normal
- •patients with known hypersensitivity to test material components
- •patients requiring systemic medications that may interfere with study
- •patients with a poor history of compliance with study requirements
结局指标
主要结局
Quanitative improvement in toenail appearance.
Assessment of dermatophyte culture and KOH examination.
Frequency and severity of adverse events.
次要结局
- Time to achieve 90% and 100% clearance of fungus from nail.
- Assessment of treatment success.
- Assessment of mycological success.