Study Evaluating the Effect of Jublia on Dermatophytomas



Status:Completed
Conditions:Podiatry
Therapuetic Areas:Orthopedics / Podiatry
Healthy:No
Age Range:18 - 70
Updated:3/21/2019
Start Date:September 2015
End Date:July 2018

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

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

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.

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.
We found this trial at
1
site
Birmingham, Alabama 35233
?
mi
from
Birmingham, AL
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