Phase 4
Completed N=13
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
Onychomycosis of Toenail
Source: ClinicalTrials.gov NCT03110029 ↗
Enrolled (actual)
13
Serious AEs
0.0%
Results posted
Mar 2019
Primary outcomePrimary: Percentage of Nail Polish Disruption Using the Likert Scale — 0.6; 0 percentage of nail polish disruption
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Nail Polish Disruption Using the Likert Scale |
0.6; 0 | — |
| SECONDARY Percentage of Disease Improvement Using Onychomycosis Severity Index (OSI) |
0.56; 0.54 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT03110029). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.