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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: Completed Phase 3 study, sponsored by Western University of Health Sciences.
NCT03168841 is a Phase 3 study that has completed, run by Western University of Health Sciences. The registered enrollment target is 40 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
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).
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 |
What the finished NCT03168841 record still lists
NCT03168841 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 1 intervention - of which Efinaconazole Topical is the first listed.
NCT03168841 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03168841's enrollment target sits among peer trials
40 1878th of 2000 higher than 103 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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