The objective of this study is to evaluate the efficacy of FST-201 compared to vehicle in the treatment of acute fungal otitis externa. This trial is designed to enable filing of a New Drug Application in support of FST-201 for the indication of acute fungal otitis externa.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
6
Instill four drops times two times a day.
Instill four times two times a day
ENT Associates of South Florida
Boynton Beach, Florida, United States
Unnamed facility
Sarasota, Florida, United States
Austin Ear, Nose, and Throat Clinic
Austin, Texas, United States
San Antonio Ear, Nose, and Throat Research
San Antonio, Texas, United States
Overall clinical cure as defined by absence of the signs and symptoms of AFOE including ear inflammation, edema, tenderness, pruritis and otic discharge.
Time frame: 1 year
Microbiological resolution defined as absence of pre-treatment pathogenic fungal species.
Time frame: 1 year
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San Antonio Ear, Nose, and Throat Research
San Antonio, Texas, United States
Ear Institute of Texas
San Antonio, Texas, United States