Clinical Trial: Study Evaluating the Effect of Jublia on Dermatophytomas
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional
Official Title: An Investigator Initiated Pilot Study Evaluating the Efficacy of Efinaconazole 10% Solution (Jublia) for the Treatment of Onychomycosis With Dermatophytomas
Brief Summary: This study will examine how Jublia affects dermatophytomas, which are difficult to treat with other therapeutic options.
Detailed Summary: 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 DLSO, and the utility of this medication likely exceeds published results. Efinaconazole solution's novel ability to penetrate into the subungal 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.
Sponsor: University of Alabama at Birmingham
Current Primary Outcome: Efficacy of efinaconazole 10% solution in the elimination of dermatophytomas that occur in DLSO [ Time Frame: week 40 ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Resolution of DLSO by assessment of % nail involvement [ Time Frame: week 4 ]Complete clinical cure of onychomycosis will be defined as 0% of nail affected on visual inspection. Percent of nail affected will also be recorded with photographs of all nails and close-up photos of target nail with and without DLSO outlined.
- Resolution of DLSO by assessment of % nail involvement [ Time Frame: week 8 ]Complete clinical cure of onychomycosis will be defined as 0% of nail affected on visual inspection. Percent of nail affected will also be recorded with photographs of all nails and close-up photos of target nail with and without DLSO outlined.
- Resolution of DLSO by assessment of % nail involvement [ Time Frame: week 12 ]Complete clinical cure of onychomycosis will be defined as 0% of nail affected on visual inspection. Percent of nail affected will also be recorded with photographs of all nails and close-up photos of target nail with and without DLSO outlined.
- Resolution of DLSO by assessment of % nail involvement [ Time Frame: week 16 ]Complete clinical cure of onychomycosis will be defined as 0% of nail affected on visual inspection. Percent of nail affected will also be recorded with photographs of all nails and close-up photos of target nail with and without DLSO outlined.
- Resolution of DLSO by assessment of % nail involvement [ Time Frame: week 24 ]Complete clinical cure of onychomycosis will be defined as 0% of nail affected on visual inspection. Percent of nail affected will also be recorded with photographs of all nails and close-up photos of target nail with and without DLSO outlined.
- Resolution of DLSO by assessment of % nail involvement [ Time Frame: week 32 ]Complete clinical cure of onychomycosis will be defined as 0% of nail affected on visual inspection. Percent of nail affected will also be recorded with photographs of all nails and close-up photos of target nail with and without DLSO outlined.
- Resolution of DLSO by assessment of % nail involvement [ Time Frame: wek 40 ]Complete clinical cure of onychomycosis will be defined as 0% of nail affected on visual inspection. Percent of nail affected will also be recorded with photographs of all nails and close-up photos of target nail with and without DLSO outlined.
- Mycological Cure [ Time Frame: week 16 ]Mycological cure will be assessed twice during the study and at the study's conclusion. A negative mycology culture result will define a mycological cure.
- Mycological Cure [ Time Frame: week 32 ]Mycological cure will be assessed twice during the study and at the study's conclusion. A negative mycology culture result will define a mycological cure.
- Mycological Cure [ Time Frame: week 40 ]Mycological cure will be assessed twice during the study and at the study's conclusion. A negative mycology culture result will define a mycological cure.
- Healthy Nail Growth [ Time Frame: week 4 ]Healthy nail growth appreciable proximally to the DLSO will be measured in the target nail using ruler (measurement in mm). The target nail will be notched at baseline thereby allowing subsequent nail growth to be assessed. The nail will be re-notched if the notch grows out.
- Healthy Nail Growth [ Time Frame: week 8 ]Healthy nail growth appreciable proximally to the DLSO will be measured in the target nail using ruler (measurement in mm). The target nail will be notched at baseline thereby allowing subsequent nail growth to be assessed. The nail will be re-notched if the notch grows out.
- Healthy Nail Growth [ Time Frame: week 16 ]Healthy nail growth appreciable proximally to the DLSO will be measured in the target nail using ruler (measurement in mm). The target nail will be notched at baseline thereby allowing subsequent nail growth to be assessed. The nail will be re-notched if the notch grows out.
- Healthy Nail Growth [ Time Frame: week 24 ]Healthy nail growth appreciable proximally to the DLSO will be measured in the target nail using ruler (measurement in mm). The target nail will be notched at baseline thereby allowing subsequent nail growth to be assessed. The nail will be re-notched if the notch grows out.
- Healthy Nail Growth [ Time Frame: week 32 ]Healthy nail growth appreciable proximally to the DLSO will be measured in the target nail using ruler (measurement in mm). The target nail will be notched at baseline thereby allowing subsequent nail growth to be as
Original Secondary Outcome: Same as current
Information By: University of Alabama at Birmingham
Dates:
Date Received: October 16, 2015
Date Started: September 2015
Date Completion: December 2017
Last Updated: March 27, 2017
Last Verified: March 2017
