Real-World Evaluation of the Effect of Jublia on Nail Polish

Recruitment & Eligibility

Inclusion Criteria

Exhibit distal lateral subungual onychomycosis (DLSO)
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, 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.

Exclusion Criteria

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.

Study & Design

Arm && Interventions

Group	Intervention	Description
Base Coat + Nail Polish + Top Coat + Efinaconazole Solution	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.
Nail Polish + Efinaconazole Solution	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)
Nail Polish + Top Coat + Efinaconazole Solution	Nail Polish + Top Coat + Efinaconazole Solution	One big toe will receive application of Efinaconazole solution on top of nail polish with top coat.
Nail Polish Only	Nail polish	Both big toes will use nail polish only

Primary Outcome Measures

Name	Time	Method
Observe Stability of Nail Polish as Evidenced by Serial Photography With Efinaconazole Application in Terms of Days	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)

Secondary Outcome Measures

Name	Time	Method

Recruitment & Eligibility