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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

Primary Purpose

Onychomycosis of Toenail

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Efinaconazole 10% Topical Application Solution [JUBLIA]
Application of Nail Polish
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Onychomycosis of Toenail

Eligibility Criteria

19 Years - 70 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • The Kirklin Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Efinaconazole 10 % and Nail Polish

Efinaconazole 10% without Nail Polish

Arm Description

Subject will have Efinaconazole 10% solution application and nail polish

Subject will have only Efinaconazole 10% application and no nail polish

Outcomes

Primary Outcome Measures

Percentage of Nail Polish Disruption Using the Likert Scale
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

Percentage of Disease Improvement Using Onychomycosis Severity Index (OSI)
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.

Full Information

First Posted
October 16, 2015
Last Updated
June 21, 2019
Sponsor
University of Alabama at Birmingham
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1. Study Identification

Unique Protocol Identification Number
NCT03110029
Brief 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
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 Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
September 2015 (undefined)
Primary Completion Date
May 2017 (Actual)
Study Completion Date
July 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Onychomycosis of Toenail

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Efinaconazole 10 % and Nail Polish
Arm Type
Active Comparator
Arm Description
Subject will have Efinaconazole 10% solution application and nail polish
Arm Title
Efinaconazole 10% without Nail Polish
Arm Type
Placebo Comparator
Arm Description
Subject will have only Efinaconazole 10% application and no nail polish
Intervention Type
Drug
Intervention Name(s)
Efinaconazole 10% Topical Application Solution [JUBLIA]
Other Intervention Name(s)
Jublia
Intervention Description
Topical efinaconazole 10% solution (Jublia)
Intervention Type
Other
Intervention Name(s)
Application of Nail Polish
Intervention Description
Application of Nail Polish
Primary Outcome Measure Information:
Title
Percentage of Nail Polish Disruption Using the Likert Scale
Description
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?
Time Frame
52 weeks
Secondary Outcome Measure Information:
Title
Percentage of Disease Improvement Using Onychomycosis Severity Index (OSI)
Description
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.
Time Frame
52 week

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boni E Elewski, MD
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Kirklin Clinic
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35249
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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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