CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 112 enrolled
Drug / intervention
Miconazole (2%) oil and mineral oil +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05660382
NCT05660382Phase 3Completed
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Randomized, Double-blind, Phase III Study of the Efficacy and Safety of Miconazole Oil, Active Versus Placebo in the Treatment of Otomycosis

Hill Dermaceuticals, Inc.·interventional·Posted Dec 21, 2022·Updated May 12, 2026

In Brief

A Phase 3 clinical trial evaluating Miconazole (2%) oil and mineral oil and Placebo for Otomycosis. Completed, enrolled 112 participants across 7 sites.

Detailed Summary

The goal of this clinical trial is to prove the that miconazole oil works well on fungal infections of the ears, by comparing the drug with a placebo. The researcher or the participants will not know if they are getting the drug or the placebo. The researcher will show the participants how to use the drug or placebo. After 14 days of using the drug or placebo, the participants will be examined by the researcher and graded on how well the drug worked on the ear(s) fungal infection. Participants will also be checked and asked for any bad side effects from the drug or the placebo.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOtomycosis
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
2023202420252026
First PostedDec 21, 2022
Enrollment StartMar 2, 2023
Primary CompletionDec 27, 2024
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 3.5 years ago

Interventions

Miconazole (2%) oil and mineral oildrug

Twice daily application, for 14 days.

Placeboother

Twice daily application, for 14 days