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NCT03130738 · ClinicalTrials.gov registry record · Phase 2
Dose-Ranging Study for Miconazole Oil for Treatment of Otomycosis
A Phase 2 study, sponsored by Hill Dermaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 65
- Enrollment target
NCT03130738: Completed Phase 2 study, sponsored by Hill Dermaceuticals.
NCT03130738 is a Phase 2 study that has completed, run by Hill Dermaceuticals. The registered enrollment target is 65 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (51% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03130738, a Phase 2 study, has completed, sponsored by Hill Dermaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 65 participants
- Enrollment target
Study Summary
The purpose of the study is to evaluate the efficacy and safety of active treatment (miconazole oil) for 7 versus 14 days, and to compare 14 days of active treatment (miconazole oil) to inactive treatment (placebo) over a 14-day treatment duration, in subjects with fungal infection (otomycosis) of the external ear.
Primary Outcome
Percentage of subjects in MITT population, at the "Test of Cure" visit with "Therapeutic cure", defined as a negative fungal culture plus "clinical cure" defined as the absence of all otomycosis signs and symptoms for pruritus, debris, fungal elements, and pain.
Interventions
- DRUG 7-Day Miconazole Oil (Miconazole 2%)
- DRUG 14-Day Miconazole Oil (Miconazole 2%)
- DRUG 14-Day Placebo - Oil Vehicle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 65 participants |
| Start Date | 2017-04-20 |
| Est. Completion | 2019-08-06 |
| Phase | Phase 2 |
What the finished NCT03130738 record still lists
NCT03130738 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 65 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (51% lower).
The record links to 0 conditions, and to 3 interventions - of which 7-Day Miconazole Oil (Miconazole 2%) is the first listed.
NCT03130738 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03130738 about?
NCT03130738 is a clinical study titled "Dose-Ranging Study for Miconazole Oil for Treatment of Otomycosis". The purpose of the study is to evaluate the efficacy and safety of active treatment (miconazole oil) for 7 versus 14 days, and to compare 14 days of active treatment (miconazole oil) to inactive treatment (placebo) over a 14-day treatment duration, in subjects with fungal infection (otomycosis) of t...
What is the current status of trial NCT03130738?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 65 participants. The study started on 2017-04-20. Estimated completion is 2019-08-06.
What interventions are being tested in trial NCT03130738?
The interventions under investigation include: 7-Day Miconazole Oil (Miconazole 2%) (DRUG), 14-Day Miconazole Oil (Miconazole 2%) (DRUG), 14-Day Placebo - Oil Vehicle (DRUG).
Who is sponsoring clinical trial NCT03130738?
This trial is sponsored by Hill Dermaceuticals, which has 4 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03130738's enrollment target sits among peer trials
65 987th of 2000 higher than 1,005 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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