An Investigator Initiated Pilot Study Evaluating the Efficacy of Efinaconazole 10% Solution (Jublia) for the Treatment of Onychomycosis With Dermatophytomas
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Number of Participants With Elimination of Dermatophytomas That Occur in Distal Lateral Subungual Onychomycosis (DLSO)
研究概览
简要总结
This study will examine how Jublia affects dermatophytomas, which are difficult to treat with other therapeutic options.
详细描述
Dermatophytomas are known to be resistant to even long courses of systemic antifungals, and have therefore been excluded from both topical and systemic clinical trials for onychomycosis, including those for Efinaconazole solution. Efinaconazole (Jublia) 10% solution is an FDA approved topical medication indicated for treatment of distal lateral subungual onychomycosis (DLSO), and the utility of this medication likely exceeds published results. Efinaconazole solution's novel ability to penetrate into the subungual space likely accounts for improved treatment results seen in DLSO treated with Jublia. We will investigate the utility of topical efinaconazole solution in the treatment of dermatophytomas.
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 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Has the informed consent been signed and patient's questions answered.
- •Age >= 18
- •Patient willing and able to participate for the full duration of the study
- •No onychomycosis
- •Greater than 4 weeks from prior major surgery for any indication
- •Willing to abstain from:
- •The application of other topical medications or cosmetic products to the toenail Professional pedicures for the duration of the study. - Females of childbearing potential must: Have been using adequate contraception (abstinence, intrauterine device (IUD), birth control pills or spermicidal gel with diaphragm or condom) since their last menses Agree to continue using adequate means of contraception (abstinence, IUD, birth control pills or spermicidal gel with diaphragm or condom) for the duration of study participation
- •Females are not considered to be of childbearing potential if they are at least 1 year postmenopausal or have had a tubal ligation, bilateral oophorectomy or hysterectomy.
排除标准
- •Active onychomycosis of the toenails or fingernails
- •Any of the following in the 4 weeks (or as indicated) prior to randomization:
- •Major surgery for any indication
- •Any personal history of: Invasive cancer diagnosed or treated within the past 5 years. Participants who have been in remission for 5 years or more and have not required treatment in the past 5 years may be eligible if the principal investigator believes there is little to no risk of recurrence.
- •Concurrent use of the following medications or treatments Other topical antifungals for any concomitant infection
- •Females who are pregnant or lactating. Should a woman become pregnant or suspect she is pregnant while she is participating in this study she should notify the study physician immediately.
- •Uncontrolled concurrent illness including ongoing or active infection, psychiatric illness/social situations that would limit compliance with study requirements or other underlying serious medical condition which, in the investigator's opinion, might preclude study participation.
研究组 & 干预措施
Jublia (Efinaconazole 10% Topical Solution) + nail polish
Subjects with distal lateral subungual onychomycosis (DLSO) with dermatophytoma.
干预措施: Jublia (Efinaconazole 10% Topical Solution) (Drug)
结局指标
主要结局
Number of Participants With Elimination of Dermatophytomas That Occur in Distal Lateral Subungual Onychomycosis (DLSO)
时间窗: week 48
Clear nail growth between the proximal nail fold and the dermatophytoma's proximal edge will be measured.
次要结局
- Clinical or Mycological Cure of Nail(week 48)
研究者
Boni Elewski, MD
Principal Investigator
University of Alabama at Birmingham