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

Study Overview
=================
Brief Summary
-----------------
A recent publication using cadaver nails suggests that Jublia application has a negative effect on nail polish texture.

Detailed Description
-----------------
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.

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

Conditions
-----------------
Evaluation of Jublia on Nail Polish With Healthy Toenails

Intervention / Treatment
-----------------
* Drug: Nail Polish + Efinaconazole Solution
* Other: Nail polish
* Drug: Base Coat + Nail Polish + Top Coat + Efinaconazole Solution
* Drug: Nail Polish + Top Coat + Efinaconazole Solution


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Nail Polish + Efinaconazole Solution<br>One big toe will receive application of Efinaconazole Solution on top of nail polish (without the presence of a top coat or base coat) | Drug: Nail Polish + Efinaconazole Solution<br>* Application of Jublia to the nail of one big toe on top of the nail polish<br>* Other names: Jublia;|
| Placebo Comparator: Nail Polish Only<br>Both big toes will use nail polish only | Other: Nail polish<br>* Application of nail polish only to both big toe nails<br>|
| Active Comparator: Base Coat + Nail Polish + Top Coat + Efinaconazole Solution<br>One big toe will receive application of Efinaconazole solution on top of nail polish with base coat and top coat. | Drug: Base Coat + Nail Polish + Top Coat + Efinaconazole Solution<br>* Application of Jublia to the nail of one big toe on top of the nail polish with layers of top coat and base coat<br>* Other names: Jublia;|
| Active Comparator: Nail Polish + Top Coat + Efinaconazole Solution<br>One big toe will receive application of Efinaconazole solution on top of nail polish with top coat. | Drug: Nail Polish + Top Coat + Efinaconazole Solution<br>* Application of Jublia to the nail of one big toe on top of the nail polish with layer of top coat<br>* Other names: Jublia;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Observe Stability of Nail Polish as Evidenced by Serial Photography With Efinaconazole Application in Terms of 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) | Baseline to 14 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
toenail polish, jublia