Dose-Ranging Study for Miconazole Oil for Treatment of Otomycosis
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
1 other identifier
interventional
65
1 country
6
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Apr 2017
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 20, 2017
CompletedFirst Submitted
Initial submission to the registry
April 21, 2017
CompletedFirst Posted
Study publicly available on registry
April 26, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 6, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
August 6, 2019
CompletedResults Posted
Study results publicly available
May 8, 2020
CompletedOctober 5, 2022
September 1, 2022
2.3 years
April 21, 2017
April 8, 2020
September 6, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Primary Efficacy Endpoint
Percentage of subjects in MITT population, at the "Test of Cure" visit with "Therapeutic cure", defined as a negative fungal culture plus "clinical cure" defined as the absence of all otomycosis signs and symptoms for pruritus, debris, fungal elements, and pain.
At Test of Cure visit (Day 15 for 7 Day Active and Day 22 for 14 Day Active and 14 Day Vehicle)
Secondary Outcomes (1)
Secondary Efficacy Endpoints
At Test of Cure visit (Day 15 for 7 Day Active and Day 22 for 14 Day Active and 14 Day Vehicle)
Study Arms (3)
7-Day Miconazole Oil (Miconazole 2%)
ACTIVE COMPARATOR7 days of 2x per day of treatment with Miconazole Oil (Active Drug Product 2% Miconazole)
14-Day Miconazole Oil (Miconazole 2%)
ACTIVE COMPARATOR14 days of 2x per day of treatment with Miconazole Oil (Active Drug Product 2% Miconazole)
14-Day Placebo - Oil Vehicle
PLACEBO COMPARATOR14 days of 2x per day of treatment with Placebo - Oil Vehicle, Study Drug base without active ingredient
Interventions
7 days of 2x per day treatment with Miconazole Oil (Active Drug Product 2% Miconazole)
14 days of 2x per day treatment with Miconazole Oil (Active Drug Product 2% Miconazole)
14 days of 2x per day treatment with Placebo - Oil Vehicle, Study Drug base without active ingredient
Eligibility Criteria
You may qualify if:
- Uncomplicated otomycosis of the external ear only, age more than 2 year
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hill Dermaceuticals, Inc.lead
- QST Consultations, Ltd.collaborator
Study Sites (6)
Head and Neck Surgery Specialist
Chula Vista, California, 91910, United States
University of California San Diego
La Jolla, California, 92037-0970, United States
Ear Nose and Throat Associates of Southe Florida
Boynton Beach, Florida, 33426, United States
Silverstein Institute
Sarasota, Florida, 34239, United States
Advanced ENT and Allergy
Louisville, Kentucky, 40207, United States
Piedmont ENT Associates
Winston-Salem, North Carolina, 27103, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Rosario G Ramirez, MD
- Organization
- Hill Dermaceuticals, Inc.
Study Officials
- STUDY DIRECTOR
Rosario G Ramirez, MD
Hill Dermaceuticals, Inc.
- PRINCIPAL INVESTIGATOR
Jack Wazen, MD
Silverstein Institute
- PRINCIPAL INVESTIGATOR
Quyen T Nguyen, MD
UCSD
- PRINCIPAL INVESTIGATOR
Kenneth Hodge, MD
Advanced ENT and Allergy
- PRINCIPAL INVESTIGATOR
Kenneth S Maxwell, MD
Piedmont Ear, Nose and Throat Associates
- PRINCIPAL INVESTIGATOR
Woo Linda, MD
Head and Neck Surgery Specialists
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Subjects, investigators, and study staff will not be masked as to the treatment duration assigned to each subject (7 versus 14 days). For subjects receiving the 14-day treatment with study drug, the contents of the study drug (active versus placebo) will be masked to the subject, investigator, and study staff.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 21, 2017
First Posted
April 26, 2017
Study Start
April 20, 2017
Primary Completion
August 6, 2019
Study Completion
August 6, 2019
Last Updated
October 5, 2022
Results First Posted
May 8, 2020
Record last verified: 2022-09
Data Sharing
- IPD Sharing
- Will not share