Efficacy and safety of miconazole oil for ear fungal infections

Randomized, Double-blind, Phase III Study of the Efficacy and Safety of Miconazole Oil, Active Versus Placebo in the Treatment of Otomycosis

This study is testing if 2% miconazole oil can effectively treat ear fungal infections in people, compared to a placebo, to see if it helps them feel better.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sex: All
• Sponsor: Hill Dermaceuticals, Inc. (Industry-sponsored)
• Locations: 7 sites (Chula Vista, California and 6 other locations)
• Trial ID: NCT05660382 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the effectiveness and safety of 2% miconazole oil in treating otomycosis, a fungal infection of the ear. Participants will be randomly assigned to receive either miconazole oil or a placebo (mineral oil) for 14 days, with both the participants and researchers blinded to the treatment received. The primary outcome will be assessed based on the clinical cure of fungal elements and associated symptoms after the treatment period. The study will take place across multiple centers in the United States, involving approximately 90 subjects diagnosed with uncomplicated otomycosis.

Who should consider this trial

Good fit: Ideal candidates include males and non-pregnant, non-lactating females diagnosed with uncomplicated otomycosis and exhibiting specific symptoms.

Not a fit: Patients with complicated otomycosis or those with significant underlying health conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide an effective topical option for patients suffering from ear fungal infections.

How similar studies have performed: Previous studies have shown promising results for antifungal treatments in similar conditions, but this specific approach with miconazole oil is relatively novel.

Eligibility criteria

Inclusion Criteria:

1. Male or non-pregnant, non-lactating females
2. Diagnosis of uncomplicated otomycosis of the external ear only, in the ear(s) that will be treated with study drug, with a score for fungal elements of 1 in each ear to be treated with study drug (see Section 7.4 for definitions of the scores for each of the otomycosis signs and symptoms). Subjects must also have the following signs and symptoms of otomycosis in the study ear: pruritus ≥2; debris ≥2; and aural fullness ≥2.
3. General good health as determined by medical examination and medical history, and who are free of clinically significant disease, including diabetes mellitus that is not well-controlled or that could interfere with the study
4. Females of childbearing potential must have had a negative urine pregnancy test at Screening/Baseline and must agree to use an effective method of contraception (as defined in Section 8.5) from Screening/Baseline up through the End of Treatment visit (see Section 6). Females of childbearing potential include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or is not postmenopausal (defined as amenorrhea \>12 consecutive months). Females who are using oral, implanted, or injectable contraceptive hormones, an intrauterine device (IUD), barrier methods (diaphragm, condoms, spermicide) to prevent pregnancy, practicing abstinence or where partner is sterile (e.g., vasectomy), should be considered to be of childbearing potential
5. Subjects and/or their caregivers (as appropriate for the age of the subject) must have full legal capacity to volunteer
6. Subjects and/or their caregivers must have completed an appropriately administered institutional review board (IRB)-approved informed consent and assent (as applicable) prior to any study related procedures
7. Subjects and their caregivers (as applicable) must agree to comply with all requirements of the protocol
8. For subjects with only one ear meeting all study eligibility criteria, the subject will be eligible for the study, and the ear meeting all eligibility criteria will be treated with study drug and considered to be the study ear for the purposes of study evaluations. In case of bilateral otomycosis in which at least one ear meet all study eligibility criteria, the subject will be eligible for the study, both ears may be treated with study drug provided that both ears have a score of 1 for fungal elements, and the worse ear will be considered to be the study ear for the purposes of study evaluations. If both ears meet study eligibility criteria and are determined by the investigator to have the same degree of infection at Screening/Baseline, the left ear will be considered to be the study ear for the purposes of study evaluations.

Exclusion Criteria:

1. Any other dermatoses or conditions of the ear that may interfere with the evaluation of otomycosis, including concomitant otic infections (including bacterial infection) that require antimicrobial treatment, disease that has spread beyond the external ear(s), or pre-existing skin atrophy of the affected ear(s) that will be treated with study drug
2. Tympanostomy tube or perforated tympanic membrane in the ear(s) that will be treated with study drug
3. History of prior surgery directly affecting and compromising the external auditory canal and/or tympanic membrane of the ear(s) that will be treated with study drug, except for prior tympanostomy tube(s) that have already been removed and completely healed
4. Use of any topical medicated treatments for otomycosis within 14 days of study entry for the ear(s) that will be treated with study drug
5. Use of any systemic antifungal therapy within 28 days of study entry, warfarin within 28 days of study entry, immunosuppressive or immune-stimulating drugs within 28 days of study entry, or systemic steroids within 3 months of study entry
6. Fever of ≥100°F at study entry
7. Recurrent otomycosis that has been unresponsive to previous antifungal treatment within the last 12 months
8. Known hypersensitivity to any of the components in the test formulation
9. Participation in another investigative trial within 28 days of study entry.

Where this trial is running

Chula Vista, California and 6 other locations

• Head and Neck Surgery Specialist — Chula Vista, California, United States (Recruiting)
• Advanced ENT & Allergy — Louisville, Kentucky, United States (Recruiting)
• Charleston ENT Associates, LLC — North Charleston, South Carolina, United States (Recruiting)
• Carolina ENT — Orangeburg, South Carolina, United States (Recruiting)
• Spartanburg / Greer ENT & Allergy — Spartanburg, South Carolina, United States (Recruiting)
• Alamo ENT Associates — San Antonio, Texas, United States (Terminated)
• ENT Center Of Utah — Salt Lake City, Utah, United States (Recruiting)

Study contacts

• Study coordinator: Rosario G G Ramirez, MD

Conditions Otomycosis