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

June 21, 2019 updated by: Boni Elewski, MD, University of Alabama at Birmingham
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

13

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35249
        • The Kirklin Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • Jublia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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?
52 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
52 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alabama at Birmingham

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2015

Primary Completion (Actual)

May 1, 2017

Study Completion (Actual)

July 1, 2018

Study Registration Dates

First Submitted

October 16, 2015

First Submitted That Met QC Criteria

April 5, 2017

First Posted (Actual)

April 12, 2017

Study Record Updates

Last Update Posted (Actual)

June 27, 2019

Last Update Submitted That Met QC Criteria

June 21, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • X141114004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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