Evaluating the Efficacy and Compatibility of Efinaconazole 10% Solution (Jublia) for the Treatment of Toenail Onychomycosis in Patients Wearing Toenail Polish Compared to Those Without Polish
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Percentage of Nail Polish Disruption Using the Likert Scale
研究概览
简要总结
This study will test how well efinaconazole solution (Jublia) works to treat toenail fungal infections in patients who wear polish compared to those who do not.
详细描述
Topical efinaconazole 10% solution is known to be an efficacious and safe treatment modality for toenail onychomycosis. This study will examine the compatibility of topical efinaconazole and nail polish in patients with distal and lateral subungual onychomycosis (DLSO). It is hypothesized that the treatment of DLSO with efinaconazole 10% solution will not be adversely affected by the application of nail polish.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female age 19-70, as 19 is the legal age in Alabama
- •DLSO affecting at least 1 great toenail diagnosed with positive potassium hydroxide microscopy and culture of a dermatophyte
- •Suitable for application of topical antifungal therapy, in the opinion of the investigator
- •Target toenail thickness of 3 mm or less as measured by digital caliper, as thickness greater than 3 mm may allow inclusion of patient with severe onychomycosis, and this was the criteria used in the pivotal trial using topical efinaconazole for onychomycosis
- •Women of childbearing potential will be required to use birth control and a negative urine pregnancy test must be documented prior to initiating treatment
排除标准
- •History of immunosuppression or concurrent use of immunosuppressant drugs
- •History of uncontrolled diabetes mellitus
- •History of psoriasis or any other condition that might interfere with the toenail evaluation
- •Three or more dermatophytomas (streaks) on the target nail
- •Severe DLSO of the target nail
- •Patients who cannot refrain from wearing gel or plastic based polishes that are used in salons and that require curing
研究组 & 干预措施
Efinaconazole 10 % and Nail Polish
Subject will have Efinaconazole 10% solution application and nail polish
干预措施: Efinaconazole 10% Topical Application Solution [JUBLIA] (Drug)
Efinaconazole 10 % and Nail Polish
Subject will have Efinaconazole 10% solution application and nail polish
干预措施: Application of Nail Polish (Other)
Efinaconazole 10% without Nail Polish
Subject will have only Efinaconazole 10% application and no nail polish
干预措施: Efinaconazole 10% Topical Application Solution [JUBLIA] (Drug)
结局指标
主要结局
Percentage of Nail Polish Disruption Using the Likert Scale
时间窗: 52 weeks
Patients will answer the following question: Which will be answered using a Likert scale where 0 represents no alteration in polish and 10 represents complete destruction of the polish: Is the quality of your polish diminished with use of Jublia?
次要结局
- Percentage of Disease Improvement Using Onychomycosis Severity Index (OSI)(52 week)
研究者
Boni Elewski, MD
Principal Investigator
University of Alabama at Birmingham