- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03168841
Efficacy and Safety of Efinaconazole 10% Solution in the Treatment of Onychomycosis in Diabetic Patients
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
Study Overview
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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California
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Pomona, California, United States, 91711
- Western University of Health Sciences
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention Group, receiving medication
Enrolled subjects with confirmed onychomycosis will be dispensed topical medication for treatment.
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Enrolled subjects will be dispensed medical for topical application, and followed for a period of 50 weeks.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Primary Endpoint - Efficacy
Time Frame: 50 weeks
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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).
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50 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Secondary Endpoint - Efficacy
Time Frame: 50 weeks
|
The first secondary efficacy end point is mycological cure, defined as negative KOH examination and negative fungal culture of the target toenail sample.
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50 weeks
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Secondary Endpoint - Efficacy
Time Frame: 50 weeks
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The second secondary efficacy end point is clinical cure, defined as 0% clinical involvement of the target toenail.
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50 weeks
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Secondary Endpoint - Safety (Occurrence of Adverse Events: Type and Frequency)
Time Frame: 50 weeks
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The secondary safety endpoint is the occurrence of adverse events (type and frequency).
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50 weeks
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2014-26
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Onychomycosis
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Vésale HospitalJanssen-Cilag Ltd.CompletedPrevalence of Onychomycosis | Diabetic Neuropathic Patients | Diagnostic of Onychomycosis | Patients Clinically Suspected of Onychomycosis | Reliability of the Diagnosis of OnychomycosisBelgium
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University of Alabama at BirminghamDUSA Pharmaceuticals, Inc.CompletedToenail Onychomycosis | Distal and Lateral Subungual Toenail OnychomycosisUnited States
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DeviceFarm, Inc.Symbio, LLC; Center for Dermatology Clinical Research, Inc.CompletedOnychomycosis Due to Trichophyton Rubrum | Onychomycosis Due to Trichophyton MentagrophytesUnited States
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Janssen Korea, Ltd., KoreaCompleted
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ToeFX Inc.Active, not recruiting
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SATO Pharmaceutical Co., Ltd.Active, not recruitingOnychomycosis of ToenailUnited States
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Mahidol UniversityCompletedNon-dermatophyte OnychomycosisThailand
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Oystershell NVCompletedOnychomycosis of ToenailTunisia
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Moberg Pharma ABCompletedDistal Subungual OnychomycosisUnited States, Canada
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PfizerCompletedOnychomycosis of ToenailsUnited States, Canada
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