Study Evaluating the Effect of Jublia on Dermatophytomas
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|ClinicalTrials.gov Identifier: NCT03098615|
Recruitment Status : Completed
First Posted : April 4, 2017
Results First Posted : March 19, 2019
Last Update Posted : December 10, 2019
|Condition or disease||Intervention/treatment||Phase|
|Onychomycosis Dermatophytosis||Drug: Jublia (Efinaconazole 10% Topical Solution)||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||19 participants|
|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)|
|Official Title:||An Investigator Initiated Pilot Study Evaluating the Efficacy of Efinaconazole 10% Solution (Jublia) for the Treatment of Onychomycosis With Dermatophytomas|
|Study Start Date :||September 2015|
|Actual Primary Completion Date :||May 2017|
|Actual Study Completion Date :||July 2018|
Jublia (Efinaconazole 10% Topical Solution) + nail polish
Subjects with distal lateral subungual onychomycosis (DLSO) with dermatophytoma.
Drug: Jublia (Efinaconazole 10% Topical Solution)
Efinaconazole 10% Topical Solution will be applied to the great toenail with the DLSO and dermatophytoma.
Other Name: Jublia
- Number of Participants With Elimination of Dermatophytomas That Occur in Distal Lateral Subungual Onychomycosis (DLSO) [ Time Frame: week 48 ]Clear nail growth between the proximal nail fold and the dermatophytoma's proximal edge will be measured.
- Clinical or Mycological Cure of Nail [ Time Frame: week 48 ]Completely normal nail plate or negative fungal culture
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03098615
|United States, Alabama|
|The Kirklin Clinic|
|Birmingham, Alabama, United States, 35249|
|Principal Investigator:||Boni E Elewski, MD||University of Alabama at Birmingham|