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.

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

sites

Piedmont ENT Associates

Winston-Salem, North Carolina 27103

Principal Investigator: Kenneth S Maxwell, MD

Phone: 336-768-3361

from

Winston-Salem, NC