Clinical Trials Logo

Clinical Trial 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.


Clinical Trial Description

The purpose of this study is to gather confirmatory data on the efficacy and safety of 2% miconazole oil after topical otic administration in subjects with otomycosis, and to fully establish evidence of efficacy for miconazole oil compared to the placebo (mineral oil). A 14-day regimen of twice-daily administration of 2% miconazole oil will be compared with the same treatment regimen using the placebo, mineral oil. This study is a randomized, double-blind, parallel-group study to be conducted at up to 8 study centers in the US. An estimated 90 male or female subjects with otomycosis will receive study drug. Subjects will be randomly assigned in a 1:1 ratio within study site to receive miconazole oil or mineral oil for 14 days [administered as 5 drops per ear at ~30 mg per drop instilled into the external ear canal of the ear(s) affected by otomycosis]. Both the subject and the investigator and study staff will be blinded as to the contents of the study drug. The primary efficacy endpoint is: • Clinical Cure, defined as score of 0 for fungal elements, and for each of the signs/symptoms of pruritus, aural fullness and debris, at the Test of Cure visit. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05660382
Study type Interventional
Source Hill Dermaceuticals, Inc.
Contact Rosario G G Ramirez, MD
Phone 4073231887
Email nini.ramirez@hillderm.com
Status Recruiting
Phase Phase 3
Start date March 2, 2023
Completion date November 2024

See also
  Status Clinical Trial Phase
Completed NCT01993823 - Clinical Study to Assess the Efficacy and Safety of G238 Compared to Clotrimazole Otic Solution in the Treatment of Otomycosis Phase 3
Completed NCT01547221 - Effectiveness of 3% Boric Acid in 70% Alcohol Versus 1% Clotrimazole Solution in Otomycosis Patients N/A
Completed NCT03686397 - SVT-15652 Otic Solution for the Treatment of Otomycosis. Phase 3
Not yet recruiting NCT06431542 - Efficacy of Self vs. Physician Application of Triamcinolone-Econazole in Otomycosis Phase 4
Completed NCT06339294 - Efficacy of Pyodine Soaked Gelfoam vs Single Topical Application of Clotrimazole in Otomycosis Treatment Phase 1
Not yet recruiting NCT04824261 - Effectiveness of 4% Boric Acid in Distilled Water Versus Clotrimazole Solution in Otomycosis Patients. N/A
Completed NCT04432376 - Efficacy and Safety Study of Miconazole Oil Versus Vehicle on Fungal Infection of the Ear Canal (Otomycosis) Phase 2/Phase 3
Completed NCT03686384 - SVT-15652 Otic Solution for the Treatment of Otomycosis Phase 3
Completed NCT04768829 - Antifungal Potential of Moringa Olifera Against Otomycosis Early Phase 1
Completed NCT03130738 - Dose-Ranging Study for Miconazole Oil for Treatment of Otomycosis Phase 2