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

The University of Alabama at Birmingham

Status and phase: Completed; Phase 4

Conditions: Onychomycosis of Toenail

Treatments: Other: Application of Nail Polish; Drug: Efinaconazole 10% Topical Application Solution [JUBLIA]

Study type: Interventional

Funder types: Other

Identifiers

NCT03110029

X141114004

Details and patient eligibility

About

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.

Full 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.

Enrollment: 13 patients

Sex: Female

Ages: 19 to 70 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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13 participants in 2 patient groups, including a placebo group

Efinaconazole 10 % and Nail Polish

Active Comparator group

Description:

Subject will have Efinaconazole 10% solution application and nail polish

Treatment:

Other: Application of Nail Polish

Drug: Efinaconazole 10% Topical Application Solution [JUBLIA]

Efinaconazole 10% without Nail Polish

Placebo Comparator group

Description:

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

Treatment:

Drug: Efinaconazole 10% Topical Application Solution [JUBLIA]