Study Evaluating the Effect of Jublia on Dermatophytomas
Condition: Onychomycosis; Dermatophytosis
MeSH terms: Onychomycosis; Tinea
Intervention: Jublia (Efinaconazole 10% Topical Solution)
Intervention description: Efinaconazole 10% Topical Solution will be applied to the great toenail with the DLSO and dermatophytoma.
Intervention MeSH terms: Efinaconazole
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
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)
Enrollment: 19.0
Sex: Female
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: Accepts Healthy Volunteers

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

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.