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

Onychomycosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03168841
• Other study ID #: 2014-26
• Status: Completed
• Phase: Phase 3
• Start date: June 6, 2017
• Est. completion date: January 9, 2019

Study information

• Verified date: October 2020
• Source: Western University of Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 9, 2019
• Est. primary completion date: January 9, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Onychomycosis

Intervention

Drug:
• Efinaconazole Topical
Enrolled subjects will be dispensed medical for topical application, and followed for a period of 50 weeks.

Locations

Country	Name	City	State
United States	Western University of Health Sciences	Pomona	California

Sponsors (1)

Lead Sponsor	Collaborator
Western University of Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	50 weeks
Secondary	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.	50 weeks
Secondary	Secondary Endpoint - Efficacy	The second secondary efficacy end point is clinical cure, defined as 0% clinical involvement of the target toenail.	50 weeks
Secondary	Secondary Endpoint - Safety (Occurrence of Adverse Events: Type and Frequency)	The secondary safety endpoint is the occurrence of adverse events (type and frequency).	50 weeks