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: 0
• Participant gender: All

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Western University of Health Sciences
• Treatments: Efinaconazole

Criteria

Inclusion Criteria:

• Clinical diagnosis of onychomycosis confirmed through positive KOH stain or positive mycologic culture findings.

• Involvement of at minimum 20% of the target great toenail.

Exclusion Criteria:

• Diagnosis of a nondermatophyte fungus infection, diagnosis of proximal subungual onychomycosis, diagnosis of superficial white onychomycosis

• Diagnosis of peripheral arterial disease or anatomic abnormalities of the target toenail

• Inability to follow through with all requisite office visits

• Routine use of a systemic corticosteroid, routine use of a systemic immunomodulator, or history of systemic antifungals within the prior five years.

• Active interdigital tinea pedis refractory to topical antifungal treatments

• Known hypersensitivity to efinaconazole

• Use, within the month preceding screening, of: topical antifungal agents, topical anti-inflammatory agents to the toes

• Any history of oral systemic antifungal with known activity against dermatophytes