Dose-Ranging Study for Miconazole Oil for Treatment of Otomycosis

NCT ID: NCT03130738

Last Updated: 2022-10-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 65 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-20
• Study Completion Date: 2019-08-06

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 Description

Miconazole, an imidazole antifungal agent, is commonly used for different types of fungal skin infections, such as Candida, ringworm, jock itch, athlete's foot, nail fungus, vaginal yeast infections, and oropharyngeal candidiasis. The 2% formulation of miconazole is commonly used for dermatophytic infections. The mechanisms of action of miconazole against fungi in general appear to be applicable to fungi associated with otomycosis, in that miconazole has been demonstrated to have activity in vitro against some clinical isolates of fungi associated with human otomycosis in the US.

Miconazole targets the cytochrome P450-dependent enzyme 14-α-sterol demethylase, an enzyme that is also involved in mammalian cholesterol synthesis, resulting in inhibition of ergosterol biosynthesis in the cell membrane of the fungal organism. Because ergosterol is an important component of the cell membrane, inhibition of its synthesis inhibits fungal cell growth.

In addition to its activity toward the enzyme 14-α-sterol demethylase, miconazole also leads to increased reactive oxygen species in fungal organisms, which appears to result in fungicidal activity.

Conditions

Otomycosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

7-Day Miconazole Oil (Miconazole 2%)

7 days of 2x per day of treatment with Miconazole Oil (Active Drug Product 2% Miconazole)

Group Type: ACTIVE_COMPARATOR

7-Day Miconazole Oil (Miconazole 2%)

Intervention Type: DRUG

7 days of 2x per day treatment with Miconazole Oil (Active Drug Product 2% Miconazole)

14-Day Miconazole Oil (Miconazole 2%)

14 days of 2x per day of treatment with Miconazole Oil (Active Drug Product 2% Miconazole)

Group Type: ACTIVE_COMPARATOR

14-Day Miconazole Oil (Miconazole 2%)

Intervention Type: DRUG

14 days of 2x per day treatment with Miconazole Oil (Active Drug Product 2% Miconazole)

14-Day Placebo - Oil Vehicle

14 days of 2x per day of treatment with Placebo - Oil Vehicle, Study Drug base without active ingredient

Group Type: PLACEBO_COMPARATOR

14-Day Placebo - Oil Vehicle

Intervention Type: DRUG

14 days of 2x per day treatment with Placebo - Oil Vehicle, Study Drug base without active ingredient

Interventions

7-Day Miconazole Oil (Miconazole 2%)

7 days of 2x per day treatment with Miconazole Oil (Active Drug Product 2% Miconazole)

Intervention Type: DRUG

14-Day Miconazole Oil (Miconazole 2%)

14 days of 2x per day treatment with Miconazole Oil (Active Drug Product 2% Miconazole)

Intervention Type: DRUG

14-Day Placebo - Oil Vehicle

14 days of 2x per day treatment with Placebo - Oil Vehicle, Study Drug base without active ingredient

Intervention Type: DRUG

Other Intervention Names

Miconazole; Miconazole; (Miconazole) Placebo Oil Vehicle

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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) that had been removed and had completely healed
• Previous use of medicated treatments for otomycosis or participation in another investigational study within 28 days of study entry
• 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
• Recurrent otomycosis that had been unresponsive to previous antifungal treatment
• Known hypersensitivity to any of the components in the test formulation

• Minimum Eligible Age: 25 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

QST Consultations, Ltd.

INDUSTRY

Sponsor Role: collaborator

Hill Dermaceuticals, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rosario G Ramirez, MD

Role: STUDY_DIRECTOR

Hill Dermaceuticals, Inc.

Jack Wazen, MD

Role: PRINCIPAL_INVESTIGATOR

Silverstein Institute

Quyen T Nguyen, MD

Role: PRINCIPAL_INVESTIGATOR

UCSD

Kenneth Hodge, MD

Role: PRINCIPAL_INVESTIGATOR

Advanced ENT and Allergy

Kenneth S Maxwell, MD

Role: PRINCIPAL_INVESTIGATOR

Piedmont Ear, Nose and Throat Associates

Woo Linda, MD

Role: PRINCIPAL_INVESTIGATOR

Head and Neck Surgery Specialists

Locations

Head and Neck Surgery Specialist

Chula Vista, California, United States

University of California San Diego

La Jolla, California, United States

Ear Nose and Throat Associates of Southe Florida

Boynton Beach, Florida, United States

Silverstein Institute

Sarasota, Florida, United States

Advanced ENT and Allergy

Louisville, Kentucky, United States

Piedmont ENT Associates

Winston-Salem, North Carolina, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

HD-MCZ-PHII-DRF062016

Identifier Type: -

Identifier Source: org_study_id