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NCT04432376 · ClinicalTrials.gov registry record · Phase 2
Efficacy and Safety Study of Miconazole Oil Versus Vehicle on Fungal Infection of the Ear Canal (Otomycosis)
A Phase 2 study, sponsored by Hill Dermaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 382
- Enrollment target
NCT04432376: Completed Phase 2 study, sponsored by Hill Dermaceuticals.
NCT04432376 is a Phase 2 study that has completed, run by Hill Dermaceuticals. The registered enrollment target is 382 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (187% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04432376, a Phase 2 study, has completed, sponsored by Hill Dermaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 382 participants
- Enrollment target
Study Summary
This study involves two portions, a randomized, double-blind portion and an open-label portion, to evaluate the efficacy and safety of Miconazole oil 2% versus its Vehicle in the treatment of fungal infection of the outer ear canal (Otomycosis). The subjects randomized in the first portion of the study will have active fungal infection of the ear(s) and will be treated with either Miconazole Oil or the Vehicle for 14 days twice daily, 5 drops into the affected ear(s) per dose. The subjects enrolled in the open-label portion of the study may or may not have active fungal infection of the ear(s), and will be given the Miconazole Oil active drug following the same application of 5 drops into the ear(s) twice daily for 14 days. The intention of the study is to evaluate the efficacy of Miconazole Oil on fungal infection of the ears when applied using 5 drops into the ear(s) twice daily for 14 days continuously. This study also intends to show safety of Miconazole Oil 5 drops into each ear twice a day for 14 consecutive days.
Primary Outcome
"therapeutic cure" is "mycological cure" plus "clinical cure, in the Modified intent to treat (MITT) only: patients with + fungal culture at baseline. Fungal culture results verified as (+) or (-) after enrollment. Intent to treat (ITT) population were all subjects enrolled and randomized. Active group: ITT=89 (100%), MITT=67 (75.3%); Placebo Group: ITT=90 (100%), MITT=64 (71.1%). Mycological cure is a negative mycological culture (culture is either positive or negative). Score=0 is best. Cli
Interventions
- DRUG miconazole 2% oil
- DRUG vehicle oil
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 382 participants |
| Start Date | 2020-07-08 |
| Est. Completion | 2021-11-01 |
| Phase | Phase 2 |
What the finished NCT04432376 record still lists
NCT04432376 is an interventional study that assigns participants to a tested intervention. The registered 382 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (187% higher).
The record links to 0 conditions, and to 2 interventions - of which miconazole 2% oil is the first listed.
NCT04432376 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04432376 about?
NCT04432376 is a clinical study titled "Efficacy and Safety Study of Miconazole Oil Versus Vehicle on Fungal Infection of the Ear Canal (Otomycosis)". This study involves two portions, a randomized, double-blind portion and an open-label portion, to evaluate the efficacy and safety of Miconazole oil 2% versus its Vehicle in the treatment of fungal infection of the outer ear canal (Otomycosis). The subjects randomized in the first portion of the st...
What is the current status of trial NCT04432376?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 382 participants. The study started on 2020-07-08. Estimated completion is 2021-11-01.
What interventions are being tested in trial NCT04432376?
The interventions under investigation include: miconazole 2% oil (DRUG), vehicle oil (DRUG).
Who is sponsoring clinical trial NCT04432376?
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 NCT04432376's enrollment target sits among peer trials
382 111th of 2000 higher than 1,890 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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