A Phase 3 interventional study of Miconazole (2%) oil and mineral oil and Placebo in Otomycosis, sponsored by Hill Dermaceuticals, Inc.. Completed at 7 sites in United States. Per ClinicalTrials.gov, last updated 2026-05-12.
Sponsored by Hill Dermaceuticals, Inc. · Phase 3, Interventional, and Treatment
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.
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:
Hill Dermaceuticals, Inc. is the lead sponsor of 4 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Miconazole (2%) oil, administered as 5 drops per ear at \~30 mg per drop instilled into the external ear canal of the ear(s) affected by otomycosis, twice daily for 14 days.
Drug: Miconazole (2%) oil and mineral oil
Mineral oil, administered as 5 drops per ear instilled into the external ear canal of the ear(s) affected by otomycosis, twice daily for 14 days.
Other: Placebo
Twice daily application, for 14 days.
Also known as: Miconazole oil
Twice daily application, for 14 days
Also known as: Mineral oil
Number of Participants With Clinical Cure
A score of 0 for fungal elements, pruritus, debris, and aural fullness
Time frame: 7 days after 14 days of Treatment
| Milestone | Active Group | Placebo Group |
|---|---|---|
| Started | 56 | 56 |
| Completed | 49 | 46 |
| Not completed | 7 | 10 |
A score of 0 for fungal elements, pruritus, debris, and aural fullness
| Participants | Active Group | Placebo Group |
|---|---|---|
| Number of Participants With Clinical Cure | 19 | 18 |
Collected over From Enrollment (Day 1) through Safety Follow Up Call, which occurred 14 days after the last day of treatment, which for subjects that complete the full 14-day treatment, the phone call should occur on Day 29 (+ 3 days). However, for subjects that do not complete the full treatment (less than 14 days), the follow-up call should occur 14 days from the last dosage.. Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Active Group | 0/56 (0%) | 0/56 (0%) | 13/56 (23.2%) |
| Placebo Group | 0/56 (0%) | 0/56 (0%) | 12/56 (21.4%) |
| Event | Active Group | Placebo Group |
|---|---|---|
| Disease progressionGeneral disorders | 8/56 | 6/56 |
| Ear discomfortEar and labyrinth disorders | 2/56 | 1/56 |
| Ear painEar and labyrinth disorders | 0/56 | 1/56 |
| Tympanic membrane disorderEar and labyrinth disorders | 1/56 | 0/56 |
| Tympanic membrane perforationEar and labyrinth disorders | 0/56 | 1/56 |
| Abdominal discomfortGastrointestinal disorders | 1/56 | 0/56 |
| CheilitisGastrointestinal disorders | 1/56 | 0/56 |
| ConstipationGastrointestinal disorders | 1/56 | 0/56 |
| NauseaGastrointestinal disorders | 0/56 | 1/56 |
| COVID-19Infections and infestations | 0/56 | 1/56 |
| Age, Categorical(Participants) | Active Group | Placebo Group | Total |
|---|---|---|---|
| <=18 years | 2 | 3 | 5 |
| Between 18 and 65 years | 27 | 25 | 52 |
| >=65 years | 27 | 28 | 55 |
| Sex: Female, Male(Participants) | Active Group | Placebo Group | Total |
|---|---|---|---|
| Female | 16 | 26 | 42 |
| Male | 40 | 30 | 70 |
| Race (NIH/OMB)(Participants) | Active Group | Placebo Group | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 1 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 8 | 13 | 21 |
| White | 46 | 41 | 87 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 2 | 1 | 3 |
| Ethnicity (NIH/OMB)(Participants) | Active Group | Placebo Group | Total |
|---|---|---|---|
| Hispanic or Latino | 14 | 10 | 24 |
| Not Hispanic or Latino | 42 | 46 | 88 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Pruritus(Participants) | Active Group | Placebo Group | Total |
|---|---|---|---|
| Mild | 0 | 0 | 0 |
| Moderate | 46 | 45 | 91 |
| Severe | 10 | 11 | 21 |
| Debris(Participants) | Active Group | Placebo Group | Total |
|---|---|---|---|
| Scant | 0 | 0 | 0 |
| Moderate | 26 | 34 | 60 |
| Heavy | 30 | 22 | 52 |
| Presence of Fungal Elements(Participants) | Active Group | Placebo Group | Total |
|---|---|---|---|
| Absent | 0 | 0 | 0 |
| Present | 56 | 56 | 112 |
| Aural Fullness(Participants) | Active Group | Placebo Group | Total |
|---|---|---|---|
| Mild | 0 | 0 | 0 |
| Moderate | 41 | 39 | 80 |
| Severe | 15 | 17 | 32 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Mar 2023 to primary completion in Dec 2024, 21 months.
Results were first posted in Apr 2026, 1 year 3 months after primary completion.
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Otomycosis
Hill Dermaceuticals, Inc.