drugset / Trial / NCT05660382

Phase III Efficacy and Safety Study of Miconazole Oil for Otomycosis

NCT05660382

Phase 3 Completed 112 enrolled Hill Dermaceuticals, Inc.
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2023-03-02
Primary completion
2024-12-27
Completion
2024-12-27

Drugs

EvaluationDrugModalityDoseRoute
Comparator Miconazole Small molecule 2 % Topical

Indications