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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

Tracking Information
First Submitted Date  ICMJE October 16, 2015
First Posted Date  ICMJE April 12, 2017
Results First Submitted Date  ICMJE August 14, 2018
Results First Posted Date  ICMJE March 20, 2019
Last Update Posted Date June 27, 2019
Study Start Date  ICMJE September 2015
Actual Primary Completion Date May 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 21, 2019)
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?
Original Primary Outcome Measures  ICMJE
 (submitted: April 5, 2017)
  • Subjective Assessments of Deterioration of Integrity of Nail Polish Quantified on Likert Scale [ Time Frame: 12 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 Julia?
  • Subjective Assessments of Deterioration of Integrity of Nail Polish Quantified on 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 Julia?
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 21, 2019)
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.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Onychomycosis of Toenail
Intervention  ICMJE
  • Drug: Efinaconazole 10% Topical Application Solution [JUBLIA]
    Topical efinaconazole 10% solution (Jublia)
    Other Name: Jublia
  • Other: Application of Nail Polish
    Application of Nail Polish
Study Arms  ICMJE
  • Active Comparator: Efinaconazole 10 % and Nail Polish
    Subject will have Efinaconazole 10% solution application and nail polish
    Interventions:
    • Drug: Efinaconazole 10% Topical Application Solution [JUBLIA]
    • Other: Application of Nail Polish
  • Placebo Comparator: Efinaconazole 10% without Nail Polish
    Subject will have only Efinaconazole 10% application and no nail polish
    Intervention: Drug: Efinaconazole 10% Topical Application Solution [JUBLIA]
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 28, 2019)
13
Original Estimated Enrollment  ICMJE
 (submitted: April 5, 2017)
20
Actual Study Completion Date  ICMJE July 2018
Actual Primary Completion Date May 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 19 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03110029
Other Study ID Numbers  ICMJE X141114004
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Boni Elewski, MD, University of Alabama at Birmingham
Study Sponsor  ICMJE University of Alabama at Birmingham
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Boni E Elewski, MD University of Alabama at Birmingham
PRS Account University of Alabama at Birmingham
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP