Summary

for people ages 25 months and up (full criteria)
at La Jolla, California and other locations
study started
estimated completion:
Quyen Nguyen

Description

Summary

The purpose of the study is to evaluate the efficacy and safety of active treatment (miconazole oil) for 7 versus 14 days, and to compare 14 days of active treatment (miconazole oil) to inactive treatment (placebo) over a 14-day treatment duration, in subjects with fungal infection (otomycosis) of the external ear.

Official Title

Dose-Ranging Study of the Efficacy and Safety of Miconazole Oil Used for 7 or 14 Days Compared With Vehicle in the Treatment of Otomycosis

Keywords

Otomycosis Miconazole 7-Day Miconazole Oil (Miconazole 2%) 14-Day Miconazole Oil (Miconazole 2%)

Eligibility

You can join if…

Open to people ages 25 months and up

  • Uncomplicated otomycosis of the external ear only, age more than 2 year

You CAN'T join if...

  • Pregnancy
  • Other dermatoses or conditions of the ear that may interfere with the evaluation of otomycosis, including concomitant otic infections (including bacterial infection) that require antimicrobial treatment, disease that has spread beyond the external ear(s),or pre-existing skin atrophy of the affected ear(s)
  • Tympanostomy tube or perforated tympanic membrane in the ear(s) that will be treated
  • Previous surgery affecting the ear(s) that will be treated, except for prior tympanostomy tube(s)
  • Previous use of medicated treatments for otomycosis
  • Previous use of any systemic antifungal therapy, warfarin, and immunosuppressive or immune-stimulating drugs within 28 days of study entry, or systemic steroids within 3 months of study entry

Locations

  • University of California San Diego accepting new patients
    La Jolla California 92037-0970 United States
  • Silverstein Institute accepting new patients
    Sarasota Florida 34239 United States
  • Ear Nose and Throat Associates of Southe Florida terminated
    Boynton Beach Florida 33426 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Hill Dermaceuticals, Inc.
ID
NCT03130738
Phase
Phase 2
Lead Scientist
Quyen Nguyen
Study Type
Interventional
Last Updated
August 6, 2018