Phase III Efficacy and Safety Study of Miconazole Oil for Otomycosis

Launched by HILL DERMACEUTICALS, INC. · Dec 13, 2022

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness and safety of a treatment called miconazole oil for a fungal infection in the ears known as otomycosis. The goal is to see if this medication works better than a placebo, which is a substance with no active ingredients. Participants in the trial will not know whether they are receiving the actual medication or the placebo. After using the treatment for 14 days, doctors will check how well it worked and if there were any side effects.

To take part in this study, participants must be healthy adults diagnosed with uncomplicated otomycosis that only affects their outer ear. They should also not have certain other ear conditions or recent treatments that could impact the results. Participants will receive instructions on how to use the treatment and will be monitored closely throughout the study. This trial is currently recruiting participants of all genders, and those who qualify will have the opportunity to contribute to important research aimed at improving treatments for ear fungal infections.

Gender

ALL

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.