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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)
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

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

First Posted
October 16, 2015
Last Updated
November 26, 2019
Sponsor
University of Alabama at Birmingham
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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
No
Data Monitoring Committee
No

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
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
No

Learn more about this trial

Study Evaluating the Effect of Jublia on Dermatophytomas

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