Real-World Evaluation of the Effect of Jublia on Nail Polish
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Observe Stability of Nail Polish as Evidenced by Serial Photography With Efinaconazole Application in Terms of Days
研究概览
简要总结
A recent publication using cadaver nails suggests that Jublia application has a negative effect on nail polish texture.
详细描述
It is believed that investigating the affect of Jublia is an important question with regards to how it affects how various nail polished and top coats will be used.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •Exhibit distal lateral subungual onychomycosis (DLSO)
- •Has the informed consent been signed and patient's questions answered.
- •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, 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 or 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
Nail Polish + Efinaconazole Solution
One big toe will receive application of Efinaconazole Solution on top of nail polish (without the presence of a top coat or base coat)
干预措施: Nail Polish + Efinaconazole Solution (Drug)
Nail Polish Only
Both big toes will use nail polish only
干预措施: Nail polish (Other)
Base Coat + Nail Polish + Top Coat + Efinaconazole Solution
One big toe will receive application of Efinaconazole solution on top of nail polish with base coat and top coat.
干预措施: Base Coat + Nail Polish + Top Coat + Efinaconazole Solution (Drug)
Nail Polish + Top Coat + Efinaconazole Solution
One big toe will receive application of Efinaconazole solution on top of nail polish with top coat.
干预措施: Nail Polish + Top Coat + Efinaconazole Solution (Drug)
结局指标
主要结局
Observe Stability of Nail Polish as Evidenced by Serial Photography With Efinaconazole Application in Terms of Days
时间窗: Baseline to 14 days
Observation: Serial photographs were combined with patient reported outcomes to assess the stability of self-applied toenail polish when efinaconazole was applied topically to the nail. (Expected stability of polish less than 14 days with application of Jublia as compared to nails without Jublia application)
次要结局
未报告次要终点
研究者
Boni Elewski, MD
Principal Investigator
University of Alabama at Birmingham