Study Evaluating the Effect of Jublia on Dermatophytomas

Phase 4

Completed

• Conditions: Dermatophytosis; Onychomycosis
• Interventions: Drug: Jublia (Efinaconazole 10% Topical Solution)

• Registration Number: NCT03098615
• Lead Sponsor: University of Alabama at Birmingham

Brief 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.

Study Timeline

• Study Start: 2015-09
• Study First Submitted: 2015-10-16
• Study First Submitted QC: 2017-03-27
• Study First Posted: 2017-04-04
• Primary Completion: 2017-05
• Study Completion: 2018-07
• Results First Submitted: 2018-09-26
• Results First Submitted QC: 2019-02-28
• Results First Posted: 2019-03-19
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-26
• Last Update Posted: 2019-12-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 19

Inclusion Criteria

• Has the informed consent been signed and patient's questions answered.
• Age >= 18
• Patient willing and able to participate for the full duration of the study
• No onychomycosis
• Greater than 4 weeks from prior major surgery for any indication
• Willing to abstain from:

The application of other topical medications or cosmetic products to the toenail Professional pedicures for the duration of the study. - Females of childbearing potential must: Have been using adequate contraception (abstinence, intrauterine device (IUD), birth control pills or spermicidal gel with diaphragm or condom) since their last menses Agree to continue using adequate means of contraception (abstinence, IUD, birth control pills or spermicidal gel with diaphragm or condom) for the duration of study participation

Females are not considered to be of childbearing potential if they are at least 1 year postmenopausal or have had a tubal ligation, bilateral oophorectomy or hysterectomy.

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Exclusion Criteria

• Active onychomycosis of the toenails or fingernails
• Any of the following in the 4 weeks (or as indicated) prior to randomization:

Major surgery for any indication

• Any personal history of: Invasive cancer diagnosed or treated within the past 5 years. Participants who have been in remission for 5 years or more and have not required treatment in the past 5 years may be eligible if the principal investigator believes there is little to no risk of recurrence.

• Concurrent use of the following medications or treatments Other topical antifungals for any concomitant infection
• Females who are pregnant or lactating. Should a woman become pregnant or suspect she is pregnant while she is participating in this study she should notify the study physician immediately.
• Uncontrolled concurrent illness including ongoing or active infection, psychiatric illness/social situations that would limit compliance with study requirements or other underlying serious medical condition which, in the investigator's opinion, might preclude study participation.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Jublia (Efinaconazole 10% Topical Solution) + nail polish	Jublia (Efinaconazole 10% Topical Solution)	Subjects with distal lateral subungual onychomycosis (DLSO) with dermatophytoma.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Elimination of Dermatophytomas That Occur in Distal Lateral Subungual Onychomycosis (DLSO)	week 48	Clear nail growth between the proximal nail fold and the dermatophytoma's proximal edge will be measured.

Secondary Outcome Measures

Name	Time	Method
Clinical or Mycological Cure of Nail	week 48	Completely normal nail plate or negative fungal culture

Trial Locations

Locations (1)

The Kirklin Clinic; 🇺🇸 Birmingham, Alabama, United States