Otomycosis Clinical Trial
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
Verified date | January 2024 |
Source | Hill Dermaceuticals, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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 affected 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 Miconazole 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.
Status | Completed |
Enrollment | 382 |
Est. completion date | November 1, 2021 |
Est. primary completion date | November 1, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 7 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Head and Neck Surgery Specialists | Chula Vista | California |
United States | University of Missouri | Columbia | Missouri |
United States | OnSite Clinical Solutions | Dillon | South Carolina |
United States | West Houston Clinical Research Services | Houston | Texas |
United States | UCSD | La Jolla | California |
United States | Lake ENT & FPS | Leesburg | Florida |
United States | Advanced ENT & Allergy | Louisville | Kentucky |
United States | DelRicht Research | New Orleans | Louisiana |
United States | Carolina ENT | Orangeburg | South Carolina |
United States | Research Your Health | Plano | Texas |
United States | DaVinci Research, LLC | Roseville | California |
United States | Sacramento ENT / DaVinci Research | Sacramento | California |
Lead Sponsor | Collaborator |
---|---|
Hill Dermaceuticals, Inc. | Abond CRO Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage of Subjects With Therapeutic Cure | "therapeutic cure" is "mycological cure" plus "clinical cure, in the Modified intent to treat (MITT) only: patients with + fungal culture at baseline. Fungal culture results verified as (+) or (-) after enrollment.
Intent to treat (ITT) population were all subjects enrolled and randomized. Active group: ITT=89 (100%), MITT=67 (75.3%); Placebo Group: ITT=90 (100%), MITT=64 (71.1%). Mycological cure is a negative mycological culture (culture is either positive or negative). Score=0 is best. Clinical cure is absence of all otomycosis signs and symptoms (s/s) of Pruritus, Debris, and Aural fullness, graded as (scores) 0=none, 1=mild, 2=moderate, 3=severe; and Presence of fungal elements, score 0=No fungal elements, 1=fungal elements present on visual inspection. Score=0 is best. Efficacy analysis was performed only on MITT (modified intent-to-treat) population, consisting of only those patients that had positive fungal culture at Baseline. |
21 days from first day of drug application | |
Secondary | Percentage of Subjects With Mycological Cure | Mycological cure is a negative mycological culture for the study ear at test of cure visit, in Modified intent to treat (MITT) only: patients with + fungal culture at baseline. Subjects that had negative fungal culture at Baseline were not included in MITT. Fungal culture results verified as (+) or (-) after enrollment.
Grading is based on positive or negative mycological (fungal) culture. Negative culture is required. Efficacy analysis was performed only on MITT (modified intent-to-treat) population, consisting of only those patients that had positive fungal culture at Baseline. Intent to treat (ITT) population were all subjects enrolled and randomized. Active group: ITT=89 (100%), MITT=67 (75.3%); Placebo Group: ITT=90 (100%), MITT=64 (71.1%). |
21 days from first day of drug application | |
Secondary | Percentage of Subjects With Clinical Cure | Absence of all otomycosis signs and symptoms according to the scales for each individual sign/symptom. Score=0 is best.
Clinical cure is absence of all otomycosis signs and symptoms of Pruritus, Debris, and Aural fullness, graded as (scores) 0=none, 1=mild, 2=moderate, 3=severe; and Presence of fungal elements, score 0=No fungal elements, 1=fungal elements present on visual inspection. Score=0 is best. Efficacy analysis was performed only on MITT (modified intent-to-treat) population, consisting of only those patients that had positive fungal culture at Baseline. Subjects that had negative fungal culture at Baseline were not included in MITT. Fungal culture results verified as (+) or (-) after enrollment. ITT (intent to treat) population were all subjects enrolled and randomized. Active group: ITT=89 (100%), MITT=67 (75.3%); Placebo Group: ITT=90 (100%), MITT=64 (71.1%). |
21 days from first day of drug application |
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