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Completed

NCT Number: NCT03098615

Study Evaluating the Effect of Jublia on Dermatophytomas

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

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Key information

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

The Kirklin Clinic

Birmingham, Alabama, 35249, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Jublia (Efinaconazole 10% Topical Solution)

Drug

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

Other names: Jublia

Primary outcomes

  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 outcomes

  1. Clinical or Mycological Cure of Nail

    Time frame: week 48

    Completely normal nail plate or negative fungal culture

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2018
First posted
Apr 4, 2017
Registry last updated
Dec 10, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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