Clinical Trial: Dose-Ranging Study for Miconazole Oil for Treatment of Otomycosis

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

Brief 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.

Detailed Summary:
Sponsor: Hill Dermaceuticals, Inc.

Current Primary Outcome: Therapeutic cure [ Time Frame: At Test of Cure visit (Day 15 for 7 Day Active and Day 22 for 14 Day Active and 14 Day Vehicle) ]

Therapeutic cure defined as a negative fungal culture plus the absence of all otomycosis signs and symptoms for pruritus, debris, fungal elements, and pain.


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Hill Dermaceuticals, Inc.

Dates:
Date Received: April 21, 2017
Date Started: April 20, 2017
Date Completion: December 2017
Last Updated: April 25, 2017
Last Verified: April 2017