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
NCT ID: NCT03110029
Last Updated: 2019-06-27
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
13 participants
INTERVENTIONAL
2015-09-30
2018-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Efinaconazole 10 % and Nail Polish
Subject will have Efinaconazole 10% solution application and nail polish
Efinaconazole 10% Topical Application Solution [JUBLIA]
Topical efinaconazole 10% solution (Jublia)
Application of Nail Polish
Application of Nail Polish
Efinaconazole 10% without Nail Polish
Subject will have only Efinaconazole 10% application and no nail polish
Efinaconazole 10% Topical Application Solution [JUBLIA]
Topical efinaconazole 10% solution (Jublia)
Interventions
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Efinaconazole 10% Topical Application Solution [JUBLIA]
Topical efinaconazole 10% solution (Jublia)
Application of Nail Polish
Application of Nail Polish
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
19 Years
70 Years
FEMALE
Yes
Sponsors
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University of Alabama at Birmingham
OTHER
Responsible Party
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Boni Elewski, MD
Principal Investigator
Principal Investigators
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Boni E Elewski, MD
Role: PRINCIPAL_INVESTIGATOR
University of Alabama at Birmingham
Locations
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The Kirklin Clinic
Birmingham, Alabama, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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X141114004
Identifier Type: -
Identifier Source: org_study_id
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