NCT03168841

Efficacy and Safety of Efinaconazole 10% Solution in the Treatment of Onychomycosis in Diabetic Patients

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Western University of Health Sciences · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Onychomycosis

Interventions

Type	Name	Description
DRUG	Efinaconazole Topical	Enrolled subjects will be dispensed medical for topical application, and followed for a period of 50 weeks.

Timeline

• Start date: 2017-06-06
• Primary completion: 2019-01-09
• Completion: 2019-01-09
• First posted: 2017-05-30
• Last updated: 2020-10-30
• Results posted: 2019-10-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study