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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

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ClinicalTrials.gov Identifier: NCT03110029
Recruitment Status : Completed
First Posted : April 12, 2017
Results First Posted : March 20, 2019
Last Update Posted : June 27, 2019
Sponsor:
Information provided by (Responsible Party):
Boni Elewski, MD, University of Alabama at Birmingham

Study Description
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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.

Condition or disease Intervention/treatment Phase
Onychomycosis of Toenail Drug: Efinaconazole 10% Topical Application Solution [JUBLIA] Other: Application of Nail Polish Phase 4

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : September 2015
Actual Primary Completion Date : May 2017
Actual Study Completion Date : July 2018

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Efinaconazole 10 % and Nail Polish
Subject will have Efinaconazole 10% solution application and nail polish
 Drug: Efinaconazole 10% Topical Application Solution [JUBLIA]
Topical efinaconazole 10% solution (Jublia)
Other Name: Jublia

Other: Application of Nail Polish
Application of Nail Polish
Placebo Comparator: Efinaconazole 10% without Nail Polish
Subject will have only Efinaconazole 10% application and no nail polish
 Drug: Efinaconazole 10% Topical Application Solution [JUBLIA]
Topical efinaconazole 10% solution (Jublia)
Other Name: Jublia


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Nail Polish Disruption Using the Likert Scale [ Time Frame: 52 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 :
  1. Percentage of Disease Improvement Using Onychomycosis Severity Index (OSI) [ Time Frame: 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.


Eligibility Criteria
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Ages Eligible for Study:   19 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03110029


Locations
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United States, Alabama
The Kirklin Clinic
Birmingham, Alabama, United States, 35249
Sponsors and Collaborators
University of Alabama at Birmingham
Investigators
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Principal Investigator: Boni E Elewski, MD University of Alabama at Birmingham
  Study Documents (Full-Text)

Documents provided by Boni Elewski, MD, University of Alabama at Birmingham:
Study Protocol and Statistical Analysis Plan  [PDF] January 14, 2019

More Information
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Responsible Party: Boni Elewski, MD, Principal Investigator, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT03110029    
Other Study ID Numbers: X141114004
First Posted: April 12, 2017    Key Record Dates
Results First Posted: March 20, 2019
Last Update Posted: June 27, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Onychomycosis
Tinea
Dermatomycoses
Skin Diseases, Infectious
Infection
Mycoses
 Nail Diseases
Skin Diseases
Efinaconazole
Antifungal Agents
Anti-Infective Agents