Status:
COMPLETED
Efficacy and Safety Study of Miconazole Oil Versus Vehicle on Fungal Infection of the Ear Canal (Otomycosis)
Lead Sponsor:
Hill Dermaceuticals, Inc.
Collaborating Sponsors:
Abond CRO Inc.
Conditions:
Otomycosis
Eligibility:
All Genders
7+ years
Phase:
PHASE2
PHASE3
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 i...
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,...
Eligibility Criteria
Inclusion
- 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
- :
- 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
Key Trial Info
Start Date :
July 8 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2021
Estimated Enrollment :
382 Patients enrolled
Trial Details
Trial ID
NCT04432376
Start Date
July 8 2020
End Date
November 1 2021
Last Update
January 19 2024
Active Locations (12)
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1
Head and Neck Surgery Specialists
Chula Vista, California, United States, 91910
2
UCSD
La Jolla, California, United States, 92037
3
DaVinci Research, LLC
Roseville, California, United States, 95661
4
Sacramento ENT / DaVinci Research
Sacramento, California, United States, 95815