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

NCT03168841 | Completed Phase 3 Results FDA Drug

• 1 other identifier: 2014-26
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Secondary Endpoint - Efficacy

  50 weeks

• Secondary Endpoint - Efficacy

  50 weeks

• Secondary Endpoint - Safety (Occurrence of Adverse Events: Type and Frequency)

  50 weeks

Study Arms (1)

Intervention Group, receiving medication

EXPERIMENTAL

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

Drug: Efinaconazole Topical

Interventions

Efinaconazole Topical DRUG

Enrolled subjects will be dispensed medical for topical application, and followed for a period of 50 weeks.

Intervention Group, receiving medication

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of onychomycosis confirmed through positive KOH stain or positive mycologic culture findings.
• Involvement of at minimum 20% of the target great toenail.

You may not qualify if:

• 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

Sponsors & Collaborators

• Western University of Health Sciences: lead

Study Sites (1)

Western University of Health Sciences

Pomona, California, 91711, United States

Location

MeSH Terms

Conditions

Onychomycosis

Interventions

efinaconazole

Condition Hierarchy (Ancestors)

Tinea; Dermatomycoses; Mycoses; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Nail Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: David Shofler
• Organization: Western University of Health Sciences

dshofler@westernu.edu

9097063898

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2017
• First Posted: May 30, 2017
• Study Start: June 6, 2017
• Primary Completion: January 9, 2019
• Study Completion: January 9, 2019
• Last Updated: October 30, 2020
• Results First Posted: October 23, 2019

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)