Dose-Ranging Study for Miconazole Oil for Treatment of Otomycosis
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | Any |
| Updated: | 3/15/2019 |
| Start Date: | April 20, 2017 |
| End Date: | December 2019 |
| Contact: | Rosario G Ramirez, MD |
| Email: | nini.ramirez@hillderm.com |
| Phone: | 407-323-1887 |
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
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.
(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.
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)
- Previous use of medicated treatments for otomycosis
- 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
We found this trial at
6
sites
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Chula Vista, California 91910
Principal Investigator: Linda Woo, MD
Phone: 619-934-3260
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9500 Gilman Dr
La Jolla, California 92093
La Jolla, California 92093
(858) 534-2230
Phone: 858-657-8590
The University of California, San Diego UC San Diego is an academic powerhouse and economic...
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Louisville, Kentucky 40207
Principal Investigator: Kenneth M Hodge, MD
Phone: 502-893-0159
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Winston-Salem, North Carolina 27103
Principal Investigator: Kenneth S Maxwell, MD
Phone: 336-768-3361
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