Randomized, Double-blind, Phase III Study of the Efficacy and Safety of Miconazole Oil Versus Vehicle Oil in the Treatment of Otomycosis, Followed by an Open-label Safety Evaluation

MZ-0120-ESP3-052

This study involves two portions, a randomized, double-blind portion and an open-label portion, to evaluate the efficacy and safety of Miconazole oil 2% versus its Vehicle in the treatment of fungal infection of the outer ear canal (Otomycosis). The subjects randomized in the first portion of the study will have active fungal infection of the ear(s) and will be treated with either Miconazole Oil or the Vehicle for 14 days twice daily, 5 drops into the affected ear(s) per dose. The subjects enrolled in the open-label portion of the study may or may not have active fungal infection of the ear(s), and will be given the Miconazole Oil active drug following the same application of 5 drops into the ear(s) twice daily for 14 days. The intention of the study is to evaluate the efficacy of Miconazole Oil on fungal infection of the ears when applied using 5 drops into the ear(s) twice daily for 14 days continuously. This study also intends to show safety of Miconazole Oil 5 drops into each ear twice a day for 14 consecutive days.

2020-07-08

2021-11-01

2021-11-01

Completed

Early phase I

382

Inclusion Criteria: Randomized blinded initial phase of study: * Male or non-pregnant, non-lactating females with a clinical diagnosis of uncomplicated otomycosis of the external ear only, * Intact tympanic membrane in the ear(s) to be treated with study drug, * In general good health as determined by medical examination and medical history, * Free of clinically significant disease, including diabetes mellitus, that is not well-controlled or that could interfere with the study. Open-label second phase of study: * Male or non-pregnant, non-lactating females with an intact tympanic membrane in the ear(s) to be treated with study drug, * In general good health as determined by medical examination and medical history, * Free of clinically significant disease, including diabetes mellitus, that is not well-controlled or that could interfere with the study. Exclusion Criteria:: * Presence of dermatoses or conditions of the ear that may interfere with evaluation of otomycosis or with safety evaluations, including concomitant otic infections that require antimicrobial treatment, * Disease that has spread beyond the external ear(s), or pre-existing skin atrophy of the affected ear(s); * Tympanostomy tube or perforated tympanic membrane; * History of prior surgery directly affecting and compromising the external auditory canal and/or tympanic membrane, 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; * 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; * Otomycosis that has been unresponsive to previous antifungal treatment; * Known hypersensitivity to any of the components in the test formulation; * Participation in another investigative trial within 28 days of study entry

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2024-01-19