Onychomycosis, a common pathology of the toenails, is even more prevalent among diabetic subjects. Nearly 26 million Americans suffer from diabetes, and approximately one-third of subjects with diabetes have toenail onychomycosis. Numerous studies have addressed the efficacy and safety of both topical and oral antifungal treatment options for onychomycosis in diabetic subjects. However, no study to date has specifically addressed the efficacy and safety of efinaconazole among diabetic subjects. The objective of this noncomparative, uncontrolled study is to determine the efficacy of topical efinaconazole 10% for toenail onychomycosis among subjects with diabetes mellitus. Specific indicators to measure efficacy of treatment will be the mycological cure rate, complete cure rate, and treatment success. Furthermore, an additional goal of the study is to gain knowledge of safety in the setting of a cohort of diabetic subjects
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Enrolled subjects will be dispensed medical for topical application, and followed for a period of 50 weeks.
Western University of Health Sciences
Pomona, California, United States
Primary Endpoint - Efficacy
The primary efficacy end point is the proportion of subjects achieving complete cure at week 50. Complete cure is to be defined as a combination of 0% clinical involvement and mycological cure (mycological cure defined as negative KOH examination and negative fungal culture of the target toenail sample).
Time frame: 50 weeks
Secondary Endpoint - Efficacy
The first secondary efficacy end point is mycological cure, defined as negative KOH examination and negative fungal culture of the target toenail sample.
Time frame: 50 weeks
Secondary Endpoint - Efficacy
The second secondary efficacy end point is clinical cure, defined as 0% clinical involvement of the target toenail.
Time frame: 50 weeks
Secondary Endpoint - Safety (Occurrence of Adverse Events: Type and Frequency)
The secondary safety endpoint is the occurrence of adverse events (type and frequency).
Time frame: 50 weeks
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