Efficacy and Safety of Efinaconazole 10% Solution in the Treatment of Onychomycosis in Diabetic Patients
Status:
Completed
Trial end date:
2019-01-09
Target enrollment:
Participant gender:
Summary
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