Dose-Ranging Study for Miconazole Oil for Treatment of Otomycosis (NCT03130738) | Clinical Trial Compass
CompletedPhase 2
Dose-Ranging Study for Miconazole Oil for Treatment of Otomycosis
United States65 participantsStarted 2017-04-20
Plain-language summary
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.
Who can participate
Age range25 Months
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
Primary Efficacy Endpoint
Timeframe: At Test of Cure visit (Day 15 for 7 Day Active and Day 22 for 14 Day Active and 14 Day Vehicle)