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NCT03168841 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of Efinaconazole 10% Solution in the Treatment of Onychomycosis in Diabetic Patients
A Phase 3 study, sponsored by Western University of Health Sciences.
- Completed
- Registry status
- Phase 3
- Development phase
- 40
- Enrollment target
NCT03168841 is a Phase 3 study that has completed, run by Western University of Health Sciences. The registered enrollment target is 40 participants.
The verdict
NCT03168841, a Phase 3 study, has completed, sponsored by Western University of Health Sciences.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 40 participants
- Enrollment target
Study 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
Interventions
- DRUG Efinaconazole Topical
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2017-06-06 |
| Est. Completion | 2019-01-09 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03168841
The ClinicalTrials.gov registry entry for NCT03168841 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Western University of Health Sciences, which has 16 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Efinaconazole Topical is the first listed.
NCT03168841 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03168841 about?
NCT03168841 is a clinical study titled "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 topic...
What is the current status of trial NCT03168841?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 40 participants. The study started on 2017-06-06. Estimated completion is 2019-01-09.
What interventions are being tested in trial NCT03168841?
The interventions under investigation include: Efinaconazole Topical (DRUG).
Who is sponsoring clinical trial NCT03168841?
This trial is sponsored by Western University of Health Sciences, which has 16 total clinical trials registered on ClinicalTrials.gov.
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