Dose-Ranging Study for Miconazole Oil for Treatment of Otomycosis
Completed · Phase 2 · Has a placebo group
Conditions studied: Otomycosis
In brief
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.
Key facts
- Study ID
- NCT03130738
- Run by
- Hill Dermaceuticals, Inc.
- People needed
- 65
- Starts
- 2017-04-20
- Expected to finish
- 2019-08-06
- Last updated by the study team
- 2022-10-05
Who can join
Age: 2 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Uncomplicated otomycosis of the external ear only, age more than 2 year
You may not qualify if…
- 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
Where it is running
- Head and Neck Surgery Specialist — Chula Vista, California, United States
- University of California San Diego — La Jolla, California, United States
- Ear Nose and Throat Associates of Southe Florida — Boynton Beach, Florida, United States
- Silverstein Institute — Sarasota, Florida, United States
- Advanced ENT and Allergy — Louisville, Kentucky, United States
- Piedmont ENT Associates — Winston-Salem, North Carolina, United States
Full record on ClinicalTrials.gov
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