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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

Phase 4
Completed
Conditions
Onychomycosis of Toenail
Interventions
Registration Number
NCT03110029
Lead Sponsor
University of Alabama at Birmingham
Brief Summary

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

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
Female
Target Recruitment
13
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
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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
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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Efinaconazole 10 % and Nail PolishEfinaconazole 10% Topical Application Solution [JUBLIA]Subject will have Efinaconazole 10% solution application and nail polish
Efinaconazole 10 % and Nail PolishApplication of Nail PolishSubject will have Efinaconazole 10% solution application and nail polish
Efinaconazole 10% without Nail PolishEfinaconazole 10% Topical Application Solution [JUBLIA]Subject will have only Efinaconazole 10% application and no nail polish
Primary Outcome Measures
NameTimeMethod
Percentage of Nail Polish Disruption Using the Likert Scale52 weeks

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?

Secondary Outcome Measures
NameTimeMethod
Percentage of Disease Improvement Using Onychomycosis Severity Index (OSI)52 week

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.

Trial Locations

Locations (1)

The Kirklin Clinic

🇺🇸

Birmingham, Alabama, United States

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