At a glance
ClinicalIndex Comparison Record- ✓Uncomplicated otomycosis of the external ear only
- ✓Age more than 2 years
- ✕Pregnancy
- ✕Concomitant otic infections (bacterial or other) requiring antimicrobial treatment
- ✕Otomycosis that has spread beyond the external ear
- ✕Pre-existing skin atrophy of the affected ear
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Dose-Ranging Study of the Efficacy and Safety of Miconazole Oil Used for 7 or 14 Days Compared With Vehicle in the Treatment of Otomycosis
In Brief
A Phase 2 clinical trial evaluating 7-Day Miconazole Oil (Miconazole 2%), 14-Day Miconazole Oil (Miconazole 2%), and 1 other intervention for Otomycosis. Completed, enrolled 65 participants across 6 sites.
Detailed 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.
Study Details
Timeline
Interventions
7 days of 2x per day treatment with Miconazole Oil (Active Drug Product 2% Miconazole)
14 days of 2x per day treatment with Miconazole Oil (Active Drug Product 2% Miconazole)
14 days of 2x per day treatment with Placebo - Oil Vehicle, Study Drug base without active ingredient