NCT03098615

Study Evaluating the Effect of Jublia on Dermatophytomas

An Investigator Initiated Pilot Study Evaluating the Efficacy of Efinaconazole 10% Solution (Jublia) for the Treatment of Onychomycosis With Dermatophytomas

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: University of Alabama at Birmingham · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

This study will examine how Jublia affects dermatophytomas, which are difficult to treat with other therapeutic options.

Detailed description

Dermatophytomas are known to be resistant to even long courses of systemic antifungals, and have therefore been excluded from both topical and systemic clinical trials for onychomycosis, including those for Efinaconazole solution. Efinaconazole (Jublia) 10% solution is an FDA approved topical medication indicated for treatment of distal lateral subungual onychomycosis (DLSO), and the utility of this medication likely exceeds published results. Efinaconazole solution's novel ability to penetrate into the subungual space likely accounts for improved treatment results seen in DLSO treated with Jublia. We will investigate the utility of topical efinaconazole solution in the treatment of dermatophytomas.

Conditions

• Onychomycosis
• Dermatophytosis

Interventions

Type	Name	Description
DRUG	Jublia (Efinaconazole 10% Topical Solution)	Efinaconazole 10% Topical Solution will be applied to the great toenail with the DLSO and dermatophytoma.

Timeline

• Start date: 2015-09-01
• Primary completion: 2017-05-01
• Completion: 2018-07-01
• First posted: 2017-04-04
• Last updated: 2019-12-10
• Results posted: 2019-03-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study