Back to resultsEfficacy and Safety of Efinaconazole 10% Solution in the Treatment of Onychomycosis in Diabetic Patients
Primary Purpose
Onychomycosis
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Efinaconazole Topical
Sponsored by
About this trial
This is an interventional treatment trial for Onychomycosis
Eligibility Criteria
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
Sites / Locations
- Western University of Health Sciences
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Intervention Group, receiving medication
Arm Description
Enrolled subjects with confirmed onychomycosis will be dispensed topical medication for treatment.
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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.
Secondary Endpoint - Efficacy
The second secondary efficacy end point is clinical cure, defined as 0% clinical involvement of the target toenail.
Secondary Endpoint - Safety (Occurrence of Adverse Events: Type and Frequency)
The secondary safety endpoint is the occurrence of adverse events (type and frequency).
Full Information
NCT ID
NCT03168841
First Posted
May 11, 2017
Last Updated
October 5, 2020
Sponsor
Western University of Health Sciences
1. Study Identification
Unique Protocol Identification Number
NCT03168841
Brief Title
Efficacy and Safety of Efinaconazole 10% Solution in the Treatment of Onychomycosis in Diabetic Patients
Official Title
Efficacy and Safety of Efinaconazole 10% Solution in the Treatment of Onychomycosis in Diabetic Patients
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
June 6, 2017 (Actual)
Primary Completion Date
January 9, 2019 (Actual)
Study Completion Date
January 9, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Western University of Health Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Onychomycosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention Group, receiving medication
Arm Type
Experimental
Arm Description
Enrolled subjects with confirmed onychomycosis will be dispensed topical medication for treatment.
Intervention Type
Drug
Intervention Name(s)
Efinaconazole Topical
Intervention Description
Enrolled subjects will be dispensed medical for topical application, and followed for a period of 50 weeks.
Primary Outcome Measure Information:
Title
Primary Endpoint - Efficacy
Description
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).
Time Frame
50 weeks
Secondary Outcome Measure Information:
Title
Secondary Endpoint - Efficacy
Description
The first secondary efficacy end point is mycological cure, defined as negative KOH examination and negative fungal culture of the target toenail sample.
Time Frame
50 weeks
Title
Secondary Endpoint - Efficacy
Description
The second secondary efficacy end point is clinical cure, defined as 0% clinical involvement of the target toenail.
Time Frame
50 weeks
Title
Secondary Endpoint - Safety (Occurrence of Adverse Events: Type and Frequency)
Description
The secondary safety endpoint is the occurrence of adverse events (type and frequency).
Time Frame
50 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Western University of Health Sciences
City
Pomona
State/Province
California
ZIP/Postal Code
91711
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Efficacy and Safety of Efinaconazole 10% Solution in the Treatment of Onychomycosis in Diabetic Patients
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