FST-201 In The Treatment of Acute Fungal Otitis Externa

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Study Completion Date

2010-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Acute Fungal Otitis Externa

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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FST-201 (dexamethasone 0.1%) Otic Suspension

Group Type EXPERIMENTAL

FST-201 (dexamethasone 0.1%) Otic Suspension

Intervention Type DRUG

Instill four drops times two times a day.

vehicle

Group Type PLACEBO_COMPARATOR

Vehicle

Intervention Type DRUG

Instill four times two times a day

Interventions

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FST-201 (dexamethasone 0.1%) Otic Suspension

Instill four drops times two times a day.

Intervention Type DRUG

Vehicle

Instill four times two times a day

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Have a clinical diagnosis of AFOE of in one or both ears, based on 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) and/or 1 for pruritis (absent = 0, present = 1)
* Have appearance consistent with fungal debris, i.e. white or black appearance consistent with Aspergillus spp. or Candida spp.
* Be at least 18 years of age at Visit 1 (Day 1, Screening/Baseline) of either sex and any race
* Provide written informed consent
* Be willing and able to follow all instructions and attend all study visits
* If female and of child bearing potential, agree to and submit a urine sample for pregnancy testing at Visit 1 and upon their exit from the study. Post menopausal is defined as having no menses for 12 consecutive months.

Exclusion Criteria

* Have known sensitivity to any component of the study medications
* Have a current infection requiring systemic antimicrobial treatment
* Take any systemic (within 30 days) or otic corticosteroids (within 1 day) prior to Visit 1
* Have used topical or systemic anti-inflammatory agents on the same day as Visit 1 and for the duration of the study
* Have used topical or systemic pain medications on the same day as Visit 1 and for the duration of the study
* Have used any topical otic treatment within 1 days prior to Visit 1

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No