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

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ClinicalTrials.gov Identifier: NCT04432376
Recruitment Status : Recruiting
First Posted : June 16, 2020
Last Update Posted : August 24, 2021
Sponsor:
Collaborator:
Abond CRO Inc.
Information provided by (Responsible Party):
Hill Dermaceuticals, Inc.

Brief 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 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 Miconazol 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.


Condition or disease Intervention/treatment Phase
Otomycosis Drug: miconazole 2% oil Drug: vehicle oil Phase 2 Phase 3

Detailed Description:

This study will be conducted in 2 portions:

  1. Enrollment A, which will consist of 2 treatment periods as follows and will be conducted in subjects with otomycosis:

    1. A randomized, double-blind, parallel-group treatment period. This treatment period will be referred to as the "Randomization Period" and will be followed by:
    2. An optional, open-label treatment period with miconazole oil. This treatment period will be referred to as the "Optional Open-label Extension."
  2. Enrollment B will consist of open-label treatment with miconazole oil in subjects who will not be required to have signs and symptoms of otomycosis.

The study will start with Enrollment A, with an estimated 220 male or female subjects with otomycosis. Subjects will be randomly assigned in a 1:1 ratio to receive miconazole oil or vehicle (placebo), for 14 days. The study drug will be administered as 5 drops per ear at ~30 mg per drop instilled into the external ear canal of the ear(s) affected by otomycosis.

In the Randomization Period, both the subject and the investigator and study staff are blinded to the contents of the study drug.

At Screening/Baseline (Day 1), assessment of the signs and symptoms of otomycosis (pruritus, debris, visual examination for presence of fungal elements, and aural fullness), evaluation of medical history, pregnancy screening in female of childbearing potential, and, prior and concomitant medications, will be collected. Subjects with positive signs and symptoms of otomycosis and who meet all eligibility criteria will enter the study. Fungal culture of affected ear(s) will be taken, debris will be cleaned from the affected ear(s), and subject will be randomized and study drug dispensed. Treatment will be for 14 days. Day 8 On Treatment Visit will include clinical evaluation of otomycosis, cleaning of ear(s), and assessment of AEs and concomitant medications, and continue treatment up to Day 14. Day 15 End of Treatment Visit will include clinical evaluation of otomycosis and fungal culture, AEs and concomitant medications assessed. Day 22 Test of Cure Visit is an assessment of clinical signs and symptoms of otomycosis and fungal culture, AEs and concomitant medications assessed, and urine pregnancy test performed in women of childbearing potential.

The Optional Open-label Extension period will allow subjects to get miconazole oil for 14 days. No unblinding of the subject's treatment in the Randomization Period will occur at this time.

For Enrollment B, male or female subjects will be enrolled to receive miconazole oil to use for 14 days and will be evaluated for safety.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 390 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Two phases; initial is randomized double-blind active vs placebo on a pre-determined number of subjects with otomycosis, to finish before starting second phase. Second phase is open-label use on diseased or healthy subjects to evaluate safety. Subjects from initial phase may crossover to second phase open-label if they meet the requirements, and new diseased or healthy subjects meeting requirements may enroll in this open-label phase.
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: Clinical Investigators, study staff and subjects randomized to the initial phase of the study are blinded to active drug and placebo.
Primary Purpose: Treatment
Official Title: Randomized, Double-blind, Phase III Study of the Efficacy and Safety of Miconazole Oil Versus Vehicle Oil in the Treatment of Otomycosis, Followed by an Open-label Safety Evaluation
Actual Study Start Date : July 8, 2020
Estimated Primary Completion Date : November 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Active treatment arm
Treatment with miconazole 2% oil, 5 drops into each ear twice daily for 14 consecutive days
Drug: miconazole 2% oil
Drug treatment of otomycosis for 14 days
Other Name: active treatment

Placebo Comparator: Placebo treatment arm
Treatment with the vehicle oil, placebo, 5 drops into each ear twice daily for 14 consecutive days
Drug: vehicle oil
Placebo treatment of otomycosis for 14 days
Other Name: placebo treatment

Open-label treatment arm
Application of miconazole 2% oil, 5 drops into each ear twice daily for 14 consecutive days
Drug: miconazole 2% oil
Drug treatment of otomycosis for 14 days
Other Name: active treatment




Primary Outcome Measures :
  1. Percentage of subjects with Therapeutic Cure [ Time Frame: 21 days from first day of drug application ]
    ""therapeutic cure" is "mycological cure" plus "clinical cure. Mycological cure is a negative mycological culture, and clinical cure is the absence of all otomycosis signs and symptoms according to the scales for each individual sign or symptom.


Secondary Outcome Measures :
  1. Percentage of subjects with mycological cure [ Time Frame: 21 days from first day of drug application ]
    Negative fungal culture

  2. Percentage of subjects with clinical cure [ Time Frame: 21 days from first day of drug application ]
    Absence of all otomycosis signs and symptoms according to the scales for each individual sign or symptom



Information from the National Library of Medicine

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Ages Eligible for Study:   7 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Randomized blinded initial phase of study:

  • Male or non-pregnant, non-lactating females with a clinical diagnosis of uncomplicated otomycosis of the external ear only,
  • Intact tympanic membrane in the ear(s) to be treated with study drug,
  • In general good health as determined by medical examination and medical history,
  • Free of clinically significant disease, including diabetes mellitus, that is not well-controlled or that could interfere with the study.

Open-label second phase of study:

  • Male or non-pregnant, non-lactating females with an intact tympanic membrane in the ear(s) to be treated with study drug,
  • In general good health as determined by medical examination and medical history,
  • Free of clinically significant disease, including diabetes mellitus, that is not well-controlled or that could interfere with the study.

Exclusion Criteria::

  • Presence of dermatoses or conditions of the ear that may interfere with evaluation of otomycosis or with safety evaluations, including concomitant otic infections 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;
  • History of prior surgery directly affecting and compromising the external auditory canal and/or tympanic membrane, except for prior tympanostomy tube(s) that have already been removed and completely healed;
  • Use of any topical medicated treatments for otomycosis within 14 days of study entry;
  • Use of any systemic antifungal therapy within 28 days of study entry, warfarin within 28 days of study entry, immunosuppressive or immune-stimulating drugs within 28 days of study entry, or systemic steroids within 3 months of study entry;
  • Fever of ≥100°F at study entry;
  • Otomycosis that has been unresponsive to previous antifungal treatment;
  • Known hypersensitivity to any of the components in the test formulation;
  • Participation in another investigative trial within 28 days of study entry

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04432376


Contacts
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Contact: Miglena Entcheva, MD 616-892-3744 mentcheva@abondcro.com
Contact: Carolyn Wright, MSRA 616-892-3765 cwright@abondcro.com

Locations
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United States, California
Head and Neck Surgery Specialists Recruiting
Chula Vista, California, United States, 91910
Contact: Linda Woo, MD    619-934-3260    lindatn@gmail.com   
Contact: Jessica Montero    6199343260    jess.montero@yahoo.com   
UCSD Recruiting
La Jolla, California, United States, 92037
Contact: Quyen Nguyen, MD    858-657-8590    Q1nguyen@health.ucsd.edu   
Contact: Sharon Mick, NP    8586576836    smick@health.ucsd.edu   
DaVinci Research, LLC Recruiting
Roseville, California, United States, 95661
Contact: Randall Ow, MD    916-736-3399 ext 1535    row@sacent.com   
Contact: Rose Khalatyan    9163746730    rkhalatyan@davinciresearch.net   
Sub-Investigator: Tim Fife, MD         
Sub-Investigator: Daniel Carlton, MD         
Sacramento ENT / DaVinci Research Recruiting
Sacramento, California, United States, 95815
Contact: Brent Benscoter, MD    916-739-3399 ext 1046    bbenscoter@sacent.com   
Contact: Marcy Adame    916-531-6141    madame@davinciresearch.net   
United States, Florida
Lake ENT & FPS Recruiting
Leesburg, Florida, United States, 34748
Contact: Sammy Vaught, MD    352-728-2404    sdvaught@gmail.com   
Contact: Hue Luong, RN    3527282404    Hue.lakeent@earthlink.net   
Sub-Investigator: Judith Milstead         
United States, Kentucky
Advanced ENT & Allergy Recruiting
Louisville, Kentucky, United States, 40220
Contact: Kenneth Hodge, MD    502-995-5525 ext 1184    khodge@advancedentandallergy.com   
Contact: Rhonda Dase, MA    5029955525 ext 1184    rdase@advancedentandallergy.com   
Sub-Investigator: Vasu Kakarlapudi, MD         
Sub-Investigator: Gregory Abbas, MD         
Sub-Investigator: Wes Allison, MD         
Sub-Investigator: Colin Neumann, MD         
Sub-Investigator: Eric Carter, MD         
Sub-Investigator: Steven Shotts, MD         
Sub-Investigator: Matthew Yantis, MD         
Sub-Investigator: Keith Forwith, PhD, MD         
Sub-Investigator: Andrew Gould, MD         
Sub-Investigator: Amy Ingram, MD         
Sub-Investigator: Nicole Hardy, PA-C         
Sub-Investigator: Grace Isaacs, PA-C         
United States, Louisiana
DelRich Research Withdrawn
Baton Rouge, Louisiana, United States, 70816
DelRicht Research Recruiting
New Orleans, Louisiana, United States, 70124
Contact: Patrick Dennis, MD    504-336-2667    pdennis@delricht.com   
Contact: Caitlin Simon    5043362667    jtaylor@delricht.com   
United States, Missouri
University of Missouri Recruiting
Columbia, Missouri, United States, 65212
Contact: Arnaldo Rivera, MD    573-884-5511    riveraal@health.missouri.edu   
Contact: Rebecca Schneider    5738822549    schneiderri@health.missouri.edu   
United States, South Carolina
OnSite Clinical Solutions Recruiting
Dillon, South Carolina, United States, 29536
Contact: Timothy Fitzgibbon, MD    800-785-3150 ext 2002    TFitzgibbonMD@onsiteclinical.com   
Contact: Angie Price    8007853150 ext 2002    aprice@onsiteclinical.com   
Sub-Investigator: Robin Shealy, MD         
Carolina ENT Recruiting
Orangeburg, South Carolina, United States, 29118
Contact: John Ansley, MD    803-536-5511    jfansley@yahoo.com   
Contact: Simone Ansley    8035365511    Sansley700@gmail.com   
Sub-Investigator: Lucius Craig III, MD         
United States, Texas
West Houston Clinical Research Services Recruiting
Houston, Texas, United States, 77055
Contact: Oscar DeValle, MD    281-738-2642    odevalle@whcrs.com   
Contact: Laura Bula    2817382642    lbula@whcrs.com   
Sub-Investigator: Nixcela Ares, MD         
Research Your Health Terminated
Plano, Texas, United States, 75093
Sponsors and Collaborators
Hill Dermaceuticals, Inc.
Abond CRO Inc.
Investigators
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Principal Investigator: Arnaldo Rivera, MD University of Missouri-Columbia
Principal Investigator: Quyen T Nguyen, MD UCSD
Principal Investigator: Kenneth Hodge, MD Advanced ENT and Allergy
Principal Investigator: Patrick Dennis, MD DelRicht Research
Principal Investigator: Sammy Vaught, MD Lake ENT & FPS
Principal Investigator: Timothy Fitzgibbon, MD OnSite Clinical Solutions
Principal Investigator: John Ansley, MD Carolina ENT
Principal Investigator: Randall Ow, MD DaVinci Research LLC
Principal Investigator: Oscar DeValle, MD West Houston Clinical Research Service
Principal Investigator: Linda Woo, MD Head and Neck Surgery Specialists
Principal Investigator: Brent Benscoter, MD Sacramento ENT / DaVinci Research
Principal Investigator: Jeffrey Adelglass, MD Research Your Health
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Responsible Party: Hill Dermaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT04432376    
Other Study ID Numbers: MZ-0120-ESP3-052
First Posted: June 16, 2020    Key Record Dates
Last Update Posted: August 24, 2021
Last Verified: August 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Otomycosis
Mycoses
Bacterial Infections and Mycoses
Infections
Ear Diseases
Otorhinolaryngologic Diseases
Miconazole
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 CYP3A Inhibitors