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

NCT ID: NCT03168841

Last Updated: 2020-10-30

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-06

Study Completion Date

2019-01-09

Brief Summary

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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

Detailed Description

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Conditions

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Onychomycosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intervention Group, receiving medication

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

Group Type EXPERIMENTAL

Efinaconazole Topical

Intervention Type DRUG

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

Interventions

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Efinaconazole Topical

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Western University of Health Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Western University of Health Sciences

Pomona, California, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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2014-26

Identifier Type: -

Identifier Source: org_study_id