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

Western University of Health Sciences (WESTERN U)

Status and phase: Completed; Phase 3

Conditions: Onychomycosis

Treatments: Drug: Efinaconazole Topical

Study type: Interventional

Funder types: Other

Identifiers

NCT03168841

2014-26

Details and patient eligibility

About

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

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Intervention Group, receiving medication

Experimental group

Description:

Enrolled subjects with confirmed onychomycosis will be dispensed topical medication for treatment.

Treatment:

Drug: Efinaconazole Topical