Phase III Efficacy and Safety Study of Miconazole Oil for Otomycosis

Completed · Phase 3 · Has a placebo group

Conditions studied: Otomycosis

In brief

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.

Key facts

Study ID: NCT05660382
Run by: Hill Dermaceuticals, Inc.
People needed: 112
Starts: 2023-03-02
Expected to finish: 2024-12-27
Last updated by the study team: 2026-05-12

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Male or non-pregnant, non-lactating females
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.
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
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
Subjects and/or their caregivers (as appropriate for the age of the subject) must have full legal capacity to volunteer
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
Subjects and their caregivers (as applicable) must agree to comply with all requirements of the protocol
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.

You may not qualify if…

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
Tympanostomy tube or perforated tympanic membrane in the ear(s) that will be treated with study drug
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
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
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
Fever of ≥100°F at study entry
Recurrent otomycosis that has been unresponsive to previous antifungal treatment within the last 12 months
Known hypersensitivity to any of the components in the test formulation
Participation in another investigative trial within 28 days of study entry.

Where it is running

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

Full record on ClinicalTrials.gov

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