Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Shire
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible 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 be 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
Clareo Health | FST-201 In The Treatment of Acute Fungal Otitis Externa
