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

• Status: Completed
• Trial end date: 2018-07-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Alabama at Birmingham
• Treatments: Efinaconazole

Criteria

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