FST-201 In The Treatment of Acute Otitis Externa

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 5

Inclusion Criteria

Have a clinical diagnosis of AOE in one or both ears, defined as a clinical score of at least 1 for edema (0-3 scale), 2 for overall inflammation (0-3 scale) and 1 for tenderness (absent=0, present=1).
Be at least 18 years of age at Visit 1 (Day 1, Screening/Baseline) of either sex and any race.
Provide written informed consent or parental assent.
Be willing and able to follow all instructions and attend all study visits

Exclusion Criteria

All subjects must not:

Have known sensitivity to any component of the study medications
Have a current infection requiring systemic antimicrobial treatment
Have used topical or systemic pain meds on the same day as Screening/Baseline Visit 1 and for the duration of the study.
Take any systemic (within 30 days) or otic corticosteroids (within 1 days) prior to Screening/Baseline Visit 1
Current use of topical or systemic non-steroidal or other anti-inflammatory drugs.
Use any topical otic treatment with alcohol, vinegar, hydrogen peroxide or other astringent medication during the course of the study or on the same day as Screening/Baseline Visit 1
Have taken any antibiotics within 3 days prior to Visit 1
Have signs and symptoms of AOE for > 4 weeks at Screening/Baseline Visit 1
Have a non-intact or perforated tympanic membrane in the enrolled ear
Have a clinical diagnosis of chronic suppurative otitis media, acute otitis media or acute otorrhea in patients with tympanostomy tubes
Have a clinical diagnosis of malignant otitis externa
Have overt fungal AOE
Have a viral infection of the pinna or tympanic membrane (i.e herpes zoster)
Have congenital abnormalities of the external auditory canal in the enrolled ear(s)
Have obstructive bony exostoses in the enrolled ear(s)
Have mastoid or other suppurative, non-infectious ear disorders (e.g, cholesteatoma)
Have malignant tumors of the external auditory canal
Have a history of otologic surgery. Surgery performed more than 1 year prior to Screening/Baseline Visit 1and limited to the tympanic membrane is allowed
Have seborrheic dermatitis of the external auditory canal
Have a current or prior history of immunosuppressive disorders
Have acute or chronic renal insufficiency, hepatitis or diabetes mellitus
Be pregnant, nursing or planning a pregnancy.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
FST-201 (dexamethasone 0.1%) Otic Suspension	FST-201 (dexamethasone 0.1%) Otic Suspension	-
ciprofloxacin 0.3%, dexamethasone 0.1%	ciprofloxacin 0.3%, dexamethasone 0.1%	-

Primary Outcome Measures

Name	Time	Method
Overall clinical cure as defined by absence of the signs and symptoms of AOE including ear inflammation, edema, tenderness and otic discharge.	1 year

Secondary Outcome Measures

Name	Time	Method
Microbiological resolution defined as elimination of pre-treatment pathogenic bacteria.	1 year

Trial Locations

Locations (4): ENT Associates of South Florida
🇺🇸
Boynton Beach, 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
Ear Institute of Texas
🇺🇸
San Antonio, Texas, United States