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CompletedNCT03098615Updated Dec 10, 2019Results posted

Study Evaluating the Effect of Jublia on Dermatophytomas

A Phase 4 interventional study of Jublia (Efinaconazole 10% Topical Solution) in Onychomycosis and Dermatophytosis, sponsored by University of Alabama at Birmingham. Completed at 1 site in United States. Open to female participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-12-10.

Sponsored by University of Alabama at Birmingham · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
19
Allocation
Not applicable
Ages
18 Years to 70 Years
Sex
Female
01

Study summary

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

Read the 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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Conditions studied

  • Onychomycosis
  • Dermatophytosis

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03

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

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

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.
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Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
19 participants (actual)

Study arms

  • Other
    Jublia (Efinaconazole 10% Topical Solution) + nail polish

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

    Drug: Jublia (Efinaconazole 10% Topical Solution)

Interventions

  • DrugJublia (Efinaconazole 10% Topical Solution)

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

    Also known as: Jublia

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: week 48

Secondary outcomes

  1. Clinical or Mycological Cure of Nail

    Completely normal nail plate or negative fungal culture

    Time frame: week 48

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Results

Posted Mar 19, 2019

Participant flow

Participant flow — Overall Study
MilestoneJublia Treatment Group
Started19
Completed17
Not completed2

Outcome measures

PrimaryNumber 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.

Time frame:
week 48
Reported as:
Count of participants · Participants
Number of Participants With Elimination of Dermatophytomas That Occur in Distal Lateral Subungual Onychomycosis (DLSO)
ParticipantsBaseline Group
Number of Participants With Elimination of Dermatophytomas That Occur in Distal Lateral Subungual Onychomycosis (DLSO)19
SecondaryClinical or Mycological Cure of Nail

Completely normal nail plate or negative fungal culture

Time frame:
week 48
Reported as:
Count of participants · Participants
Clinical or Mycological Cure of Nail
ParticipantsJublia (Efinaconazole 10% Topical Solution) + Nail Polish
Clinical or Mycological Cure of Nail12

Adverse events

Collected over 48 months. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Baseline Group0/19 (0%)0/19 (0%)0/19 (0%)

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Baseline Group
<=18 years0
Between 18 and 65 years16
>=65 years3
Sex: Female, Male
Sex: Female, Male(Participants)Baseline Group
Female7
Male12
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Baseline Group
American Indian or Alaska Native0
Asian0
Native Hawaiian or Other Pacific Islander0
Black or African American3
White16
More than one race0
Unknown or Not Reported0
Region of Enrollment
Region of Enrollment(participants)Baseline Group
United States19
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Study locations

1 site
  • The Kirklin Clinic
    Birmingham, Alabama 35249, United States
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References and documents

Study documents

  • Protocol and statistical analysis plan · Mar 29, 2017

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

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Registry details

Key details

Study ID
NCT03098615
Lead sponsor
University of Alabama at Birmingham
Responsible party
Boni Elewski, MD (Principal Investigator, University of Alabama at Birmingham) — Principal investigator
First posted
Apr 4, 2017
Start date
Sep 2015
Primary completion
May 2017
Completion
Jul 2018
Results posted
Mar 19, 2019
Last update
Dec 10, 2019

Study contacts

Boni E Elewski, MD
principal investigator · University of Alabama at Birmingham

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2019. You cannot join it, but the record below documents what was studied.

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