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
Completed · Phase 4
Conditions studied: Onychomycosis of Toenail
In brief
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.
Key facts
- Study ID
- NCT03110029
- Run by
- University of Alabama at Birmingham
- People needed
- 13
- Starts
- 2015-09-01
- Expected to finish
- 2018-07-01
- Last updated by the study team
- 2019-06-27
Who can join
Age: 19 and older, up to 70. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- The Kirklin Clinic — Birmingham, Alabama, United States
Full record on ClinicalTrials.gov
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