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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Onychomycosis of Toenail

Intervention / Treatment
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* Drug: Efinaconazole 10% Topical Application Solution [JUBLIA]
* Other: Application of Nail Polish


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Efinaconazole 10 % and Nail Polish<br>Subject will have Efinaconazole 10% solution application and nail polish | Drug: Efinaconazole 10% Topical Application Solution [JUBLIA]<br>* Topical efinaconazole 10% solution (Jublia)<br>* Other names: Jublia;Other: Application of Nail Polish<br>* Application of Nail Polish<br>|
| Placebo Comparator: Efinaconazole 10% without Nail Polish<br>Subject will have only Efinaconazole 10% application and no nail polish | Drug: Efinaconazole 10% Topical Application Solution [JUBLIA]<br>* Topical efinaconazole 10% solution (Jublia)<br>* Other names: Jublia;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Nail Polish Disruption Using the Likert Scale | 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? | 52 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Disease Improvement Using Onychomycosis Severity Index (OSI) | Using 3rd party blinding, DLSO was assessed at baseline and at every subsequent visit using the onychomycosis severity index (OSI), measuring percent of the target nail involved, and grading the infection from mild to moderate to severe. The range for OSI is 0-20 with 20 indicating severe nails disease. Nail growth was measured at each visit. Fungal testing was done at screening, 3 months, 7 months, end of treatment (48 weeks), and end of study (52 weeks). Clinical and mycologic cure was evaluated at week 52. | 52 week |