Efficacy and Safety Study of Miconazole Oil Versus Vehicle on Fungal Infection of the Ear Canal (Otomycosis)
Public ClinicalTrials.gov record NCT04432376. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Randomized, Double-blind, Phase III Study of the Efficacy and Safety of Miconazole Oil Versus Vehicle Oil in the Treatment of Otomycosis, Followed by an Open-label Safety Evaluation
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04432376
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2, Phase 3
- Enrollment
- 382 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 7 Years and older
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 7, 2020
- Primary completion
- Oct 31, 2021
- Completion
- Oct 31, 2021
- Last update posted
- Jan 18, 2024
2020 – 2021
United States locations
- U.S. sites
- 12
- U.S. states
- 7
- U.S. cities
- 12
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Head and Neck Surgery Specialists | Chula Vista | California | 91910 | — |
| UCSD | La Jolla | California | 92037 | — |
| DaVinci Research, LLC | Roseville | California | 95661 | — |
| Sacramento ENT / DaVinci Research | Sacramento | California | 95815 | — |
| Lake ENT & FPS | Leesburg | Florida | 34748 | — |
| Advanced ENT & Allergy | Louisville | Kentucky | 40220 | — |
| DelRicht Research | New Orleans | Louisiana | 70124 | — |
| University of Missouri | Columbia | Missouri | 65212 | — |
| OnSite Clinical Solutions | Dillon | South Carolina | 29536 | — |
| Carolina ENT | Orangeburg | South Carolina | 29118 | — |
| West Houston Clinical Research Services | Houston | Texas | 77055 | — |
| Research Your Health | Plano | Texas | 75093 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04432376, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jan 18, 2024 · Synced Sep 8, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04432376 live on ClinicalTrials.gov.