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Study Evaluating the Effect of Jublia on Dermatophytomas

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ClinicalTrials.gov Identifier: NCT03098615
Recruitment Status : Completed
First Posted : April 4, 2017
Results First Posted : March 19, 2019
Last Update Posted : August 26, 2019
Sponsor:
Information provided by (Responsible Party):
Boni Elewski, MD, University of Alabama at Birmingham

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

Condition or disease Intervention/treatment Phase
Onychomycosis Dermatophytosis Drug: Jublia (Efinaconazole 10% Topical Solution) Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Topical application of Jublia (Efinaconazole 10% Topical Solution) to patients with distal lateral subungual onychomycosis with dermatophytoma.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Investigator Initiated Pilot Study Evaluating the Efficacy of Efinaconazole 10% Solution (Jublia) for the Treatment of Onychomycosis With Dermatophytomas
Study Start Date : September 2015
Actual Primary Completion Date : May 2017
Actual Study Completion Date : July 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Jublia (Efinaconazole 10% Topical Solution) + nail polish
Subjects with distal lateral subungual onychomycosis (DLSO) with dermatophytoma.
Drug: Jublia (Efinaconazole 10% Topical Solution)
Efinaconazole 10% Topical Solution will be applied to the great toenail with the DLSO and dermatophytoma.
Other Name: Jublia




Primary Outcome Measures :
  1. Number of Participants With Elimination of Dermatophytomas That Occur in Distal Lateral Subungual Onychomycosis (DLSO) [ Time Frame: week 48 ]
    Clear nail growth between the proximal nail fold and the dermatophytoma's proximal edge will be measured.


Secondary Outcome Measures :
  1. Clinical or Mycological Cure of Nail [ Time Frame: week 48 ]
    Completely normal nail plate or negative fungal culture



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03098615


Locations
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United States, Alabama
The Kirklin Clinic
Birmingham, Alabama, United States, 35249
Sponsors and Collaborators
University of Alabama at Birmingham
Investigators
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Principal Investigator: Boni E Elewski, MD University of Alabama at Birmingham
  Study Documents (Full-Text)

Documents provided by Boni Elewski, MD, University of Alabama at Birmingham:

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Responsible Party: Boni Elewski, MD, Principal Investigator, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT03098615     History of Changes
Other Study ID Numbers: F150408010
First Posted: April 4, 2017    Key Record Dates
Results First Posted: March 19, 2019
Last Update Posted: August 26, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Onychomycosis
Tinea
Dermatomycoses
Skin Diseases, Infectious
Infection
Mycoses
Nail Diseases
Skin Diseases
Efinaconazole
Pharmaceutical Solutions
Antifungal Agents
Anti-Infective Agents