Dose-Ranging Study of the Efficacy and Safety of Miconazole Oil Used for 7 or 14 Days Compared With Vehicle in the Treatment of Otomycosis

HD-MCZ-PHII-DRF062016

The purpose of the study is to evaluate the efficacy and safety of active treatment (miconazole oil) for 7 versus 14 days, and to compare 14 days of active treatment (miconazole oil) to inactive treatment (placebo) over a 14-day treatment duration, in subjects with fungal infection (otomycosis) of the external ear.

2017-04-20

2019-08-06

2019-08-06

Completed

Early phase I

65

Inclusion Criteria: * Uncomplicated otomycosis of the external ear only, age more than 2 year Exclusion Criteria: * Pregnancy * 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) * Tympanostomy tube or perforated tympanic membrane in the ear(s) that will be treated * Previous surgery affecting the ear(s) that will be treated, except for prior tympanostomy tube(s) that had been removed and had completely healed * Previous use of medicated treatments for otomycosis or participation in another investigational study within 28 days of study entry * Previous use of any systemic antifungal therapy, warfarin, and immunosuppressive or immune-stimulating drugs within 28 days of study entry, or systemic steroids within 3 months of study entry * Recurrent otomycosis that had been unresponsive to previous antifungal treatment * Known hypersensitivity to any of the components in the test formulation

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2022-10-05