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Dose-Ranging Study for Miconazole Oil for Treatment of Otomycosis

NCT03130738 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2022-10-05

Study results available
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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.

Conditions

  • Otomycosis

Interventions

DRUG

7-Day Miconazole Oil (Miconazole 2%)

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

DRUG

14-Day Miconazole Oil (Miconazole 2%)

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

DRUG

14-Day Placebo - Oil Vehicle

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

Sponsors & Collaborators

  • QST Consultations, Ltd.

    collaborator INDUSTRY

  • Hill Dermaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Rosario G Ramirez, MD · Hill Dermaceuticals, Inc.

  • Jack Wazen, MD · Silverstein Institute

  • Quyen T Nguyen, MD · UCSD

  • Kenneth Hodge, MD · Advanced ENT and Allergy

  • Kenneth S Maxwell, MD · Piedmont Ear, Nose and Throat Associates

  • Woo Linda, MD · Head and Neck Surgery Specialists

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
25 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-20
Primary Completion
2019-08-06
Completion
2019-08-06
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03130738 on ClinicalTrials.gov