FST-201 In The Treatment of Acute Fungal Otitis Externa
A Multi-Center, Randomized, Double-Masked, Vehicle-Controlled Clinical Study Evaluating the Efficacy Of FST-201 (Dexamethasone 0.1%) Otic Suspension in Subjects With Acute Fungal Otitis Externa
1 other identifier
interventional
6
1 country
6
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Jul 2009
Shorter than P25 for phase_3
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 23, 2009
CompletedFirst Posted
Study publicly available on registry
July 24, 2009
CompletedStudy Start
First participant enrolled
July 31, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2010
CompletedMay 27, 2021
May 1, 2021
1 year
July 23, 2009
May 24, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Overall clinical cure as defined by absence of the signs and symptoms of AFOE including ear inflammation, edema, tenderness, pruritis and otic discharge.
1 year
Secondary Outcomes (1)
Microbiological resolution defined as absence of pre-treatment pathogenic fungal species.
1 year
Study Arms (2)
FST-201 (dexamethasone 0.1%) Otic Suspension
EXPERIMENTALvehicle
PLACEBO COMPARATORInterventions
Instill four drops times two times a day.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Shirelead
Study Sites (6)
ENT Associates of South Florida
Boynton Beach, Florida, 33426, United States
Unknown Facility
Sarasota, Florida, 34239, United States
Austin Ear, Nose, and Throat Clinic
Austin, Texas, 78705, United States
San Antonio Ear, Nose, and Throat Research
San Antonio, Texas, 78215, United States
San Antonio Ear, Nose, and Throat Research
San Antonio, Texas, 78229, United States
Ear Institute of Texas
San Antonio, Texas, 78258, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Study Director
Takeda
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 23, 2009
First Posted
July 24, 2009
Study Start
July 31, 2009
Primary Completion
July 31, 2010
Study Completion
July 31, 2010
Last Updated
May 27, 2021
Record last verified: 2021-05