Efficacy and Safety of Efinaconazole 10% Solution in the Treatment of Onychomycosis in Diabetic Patients
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|ClinicalTrials.gov Identifier: NCT03168841|
Recruitment Status : Active, not recruiting
First Posted : May 30, 2017
Last Update Posted : October 5, 2018
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
|Condition or disease||Intervention/treatment||Phase|
|Onychomycosis||Drug: Efinaconazole Topical||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||48 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Efficacy and Safety of Efinaconazole 10% Solution in the Treatment of Onychomycosis in Diabetic Patients|
|Actual Study Start Date :||June 6, 2017|
|Estimated Primary Completion Date :||December 20, 2018|
|Estimated Study Completion Date :||December 20, 2018|
Experimental: Intervention Group, receiving medication
Enrolled subjects with confirmed onychomycosis will be dispensed topical medication for treatment.
Drug: Efinaconazole Topical
Enrolled subjects will be dispensed medical for topical application, and followed for a period of 50 weeks.
- Primary endpoint - Efficacy [ Time Frame: 50 weeks ]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 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.
- Secondary endpoint - Efficacy [ Time Frame: 50 weeks ]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) [ Time Frame: 50 weeks ]The secondary safety endpoint is the occurrence of adverse events (type and frequency).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03168841
|United States, California|
|Western University of Health Sciences|
|Pomona, California, United States, 91711|