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Study Evaluating the Effect of Jublia on Dermatophytomas

Primary Purpose

Onychomycosis, Dermatophytosis

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Jublia (Efinaconazole 10% Topical Solution)

About this trial

This is an interventional treatment trial for Onychomycosis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

The Kirklin Clinic

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Jublia (Efinaconazole 10% Topical Solution) + nail polish

Arm Description

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

Outcomes

Primary Outcome Measures

Number of Participants With Elimination of Dermatophytomas That Occur in Distal Lateral Subungual Onychomycosis (DLSO)

Clear nail growth between the proximal nail fold and the dermatophytoma's proximal edge will be measured.

Secondary Outcome Measures

Clinical or Mycological Cure of Nail

Completely normal nail plate or negative fungal culture

Full Information

NCT ID

NCT03098615

First Posted

October 16, 2015

Last Updated

November 26, 2019

Sponsor

University of Alabama at Birmingham

1. Study Identification

Unique Protocol Identification Number

NCT03098615

Brief Title

Study Evaluating the Effect of Jublia on Dermatophytomas

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2019

Overall Recruitment Status

Completed

Study Start Date

September 2015 (undefined)

Primary Completion Date

May 2017 (Actual)

Study Completion Date

July 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Alabama at Birmingham

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Onychomycosis, Dermatophytosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Model Description

Topical application of Jublia (Efinaconazole 10% Topical Solution) to patients with distal lateral subungual onychomycosis with dermatophytoma.

Masking

None (Open Label)

Allocation

N/A

Enrollment

19 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Jublia (Efinaconazole 10% Topical Solution) + nail polish

Arm Type

Other

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Jublia (Efinaconazole 10% Topical Solution)

Other Intervention Name(s)

Jublia

Intervention Description

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

Primary Outcome Measure Information:

Title

Number of Participants With Elimination of Dermatophytomas That Occur in Distal Lateral Subungual Onychomycosis (DLSO)

Description

Clear nail growth between the proximal nail fold and the dermatophytoma's proximal edge will be measured.

Time Frame

week 48

Secondary Outcome Measure Information:

Title

Clinical or Mycological Cure of Nail

Description

Completely normal nail plate or negative fungal culture

Time Frame

week 48

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Boni E Elewski, MD

Organizational Affiliation

University of Alabama at Birmingham

Official's Role

Principal Investigator

Facility Information:

Facility Name

The Kirklin Clinic

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35249

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Study Evaluating the Effect of Jublia on Dermatophytomas

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