Efficacy and Safety Study of Miconazole Oil Versus Vehicle on Fungal Infection of the Ear Canal (Otomycosis)

Summary

This study involves two portions, a randomized, double-blind portion and an open-label portion, to evaluate the efficacy and safety of Miconazole oil 2% versus its Vehicle in the treatment of fungal infection of the outer ear canal (Otomycosis). The subjects randomized in the first portion of the study will have active fungal infection of the ear(s) and will be treated with either Miconazole Oil or the Vehicle for 14 days twice daily, 5 drops into the affected ear(s) per dose. The subjects enrolled in the open-label portion of the study may or may not have active fungal infection of the ear(s), and will be given the Miconazole Oil active drug following the same application of 5 drops into the ear(s) twice daily for 14 days.

The intention of the study is to evaluate the efficacy of Miconazole Oil on fungal infection of the ears when applied using 5 drops into the ear(s) twice daily for 14 days continuously. This study also intends to show safety of Miconazole Oil 5 drops into each ear twice a day for 14 consecutive days.

Conditions

• Otomycosis

Interventions

DRUG

miconazole 2% oil

Drug treatment of otomycosis for 14 days

DRUG

vehicle oil

Placebo treatment of otomycosis for 14 days

Sponsors & Collaborators

• Abond CRO Inc.

  collaborator OTHER

• Hill Dermaceuticals, Inc.

  lead INDUSTRY

Principal Investigators

• Arnaldo Rivera, MD · University of Missouri-Columbia

• Quyen T Nguyen, MD · UCSD

• Kenneth Hodge, MD · Advanced ENT and Allergy

• Patrick Dennis, MD · DelRicht Research

• Sammy Vaught, MD · Lake ENT & FPS

• Timothy Fitzgibbon, MD · OnSite Clinical Solutions

• John Ansley, MD · Carolina ENT

• Randall Ow, MD · DaVinci Research LLC

• Oscar DeValle, MD · West Houston Clinical Research Service

• Linda Woo, MD · Head and Neck Surgery Specialists

• Brent Benscoter, MD · Sacramento ENT / DaVinci Research

• Jeffrey Adelglass, MD · Research Your Health

• Gary Brandt, MD · Delricht

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

CROSSOVER

Eligibility

Min Age

7 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2020-07-08

Primary Completion

2021-11-01

Completion

2021-11-01

FDA Drug

Yes

Countries

• United States

Study Locations