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 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03110029
• Other study ID #: X141114004
• Status: Completed
• Phase: Phase 4
• Start date: September 2015
• Est. completion date: July 2018

Study information

• Verified date: June 2019
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: July 2018
• Est. primary completion date: May 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 19 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Onychomycosis
• Onychomycosis of Toenail

Intervention

Drug:
• Efinaconazole 10% Topical Application Solution [JUBLIA]
Topical efinaconazole 10% solution (Jublia)

Other:
• Application of Nail Polish
Application of Nail Polish

Locations

Country	Name	City	State
United States	The Kirklin Clinic	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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?	52 weeks
Secondary	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.	52 week