The Kirklin Clinic
Birmingham, Alabama, 35249, United States
NCT Number: NCT03098615
This study will examine how Jublia affects dermatophytomas, which are difficult to treat with other therapeutic options.
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Notify Me18 year–70 year
Female
Interventional
Phase 4
Birmingham, Alabama, 35249, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
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
Major surgery for any indication
Efinaconazole 10% Topical Solution will be applied to the great toenail with the DLSO and dermatophytoma.
Other names: Jublia
Time frame: week 48
Clear nail growth between the proximal nail fold and the dermatophytoma's proximal edge will be measured.
Time frame: week 48
Completely normal nail plate or negative fungal culture
University of Alabama at Birmingham
Other
An Investigator Initiated Pilot Study Evaluating the Efficacy of Efinaconazole 10% Solution (Jublia) for the Treatment of Onychomycosis With Dermatophytomas
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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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