Study Evaluating the Effect of Jublia on Dermatophytomas

NCT ID: NCT03098615

Last Updated: 2019-12-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-30
• Study Completion Date: 2018-07-31

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.

Conditions

Onychomycosis; Dermatophytosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Jublia (Efinaconazole 10% Topical Solution) + nail polish

Subjects with distal lateral subungual onychomycosis (DLSO) with dermatophytoma.

Group Type: OTHER

Jublia (Efinaconazole 10% Topical Solution)

Intervention Type: DRUG

Efinaconazole 10% Topical Solution will be applied to the great toenail with the DLSO and dermatophytoma.

Interventions

Jublia (Efinaconazole 10% Topical Solution)

Efinaconazole 10% Topical Solution will be applied to the great toenail with the DLSO and dermatophytoma.

Intervention Type: DRUG

Other Intervention Names

Jublia

Eligibility Criteria

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.

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

Boni Elewski, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Boni E Elewski, MD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

The Kirklin Clinic

Birmingham, Alabama, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

F150408010

Identifier Type: -

Identifier Source: org_study_id