Clinical trial NCT03130738: Dose-Ranging Study for Miconazole Oil for Treatment of Otomycosis
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Otomycosis
Lead sponsor: Hill Dermaceuticals, Inc.
Sponsor class: INDUSTRY
Collaborators: name: QST Consultations, Ltd.
First posted: 2017-04-26
Enrollment: 65
Sex: ALL
Minimum age (years): 25
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: Miconazole, an imidazole antifungal agent, is commonly used for different types of fungal skin infections, such as Candida, ringworm, jock itch, athlete's foot, nail fungus, vaginal yeast infections, and oropharyngeal candidiasis. The 2% formulation of miconazole is commonly used for dermatophytic infections. The mechanisms of action of miconazole against fungi in general appear to be applicable to fungi associated with otomycosis, in that miconazole has been demonstrated to have activity in vitro against some clinical isolates of fungi associated with human otomycosis in the US.

Miconazole targets the cytochrome P450-dependent enzyme 14-α-sterol demethylase, an enzyme that is also involved in mammalian cholesterol synthesis, resulting in inhibition of ergosterol biosynthesis in the cell membrane of the fungal organism. Because ergosterol is an important component of the cell membrane, inhibition of its synthesis inhibits fungal cell growth.

In addition to its activity toward the enzyme 14-α-sterol demethylase, miconazole also leads to increased reactive oxygen species in fungal organisms, which appears to result in fungicidal activity.

Eligibility criteria: Inclusion Criteria:

* Uncomplicated otomycosis of the external ear only, age more than 2 year

Exclusion Criteria:

* 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

Primary outcomes:
measure: Primary Efficacy Endpoint
timeFrame: At Test of Cure visit (Day 15 for 7 Day Active and Day 22 for 14 Day Active and 14 Day Vehicle)
Secondary outcomes:
measure: Secondary Efficacy Endpoints
timeFrame: At Test of Cure visit (Day 15 for 7 Day Active and Day 22 for 14 Day Active and 14 Day Vehicle)
Other outcomes:
Locations:
city: Chula Vista
country: United States
facility: Head and Neck Surgery Specialist
state: California
city: La Jolla
country: United States
facility: University of California San Diego
state: California
city: Boynton Beach
country: United States
facility: Ear Nose and Throat Associates of Southe Florida
state: Florida
city: Sarasota
country: United States
facility: Silverstein Institute
state: Florida
city: Louisville
country: United States
facility: Advanced ENT and Allergy
state: Kentucky
city: Winston-Salem
country: United States
facility: Piedmont ENT Associates
state: North Carolina
Study officials:
affiliation: Hill Dermaceuticals, Inc.
name: Rosario G Ramirez, MD
role: STUDY_DIRECTOR
affiliation: Silverstein Institute
name: Jack Wazen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: UCSD
name: Quyen T Nguyen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Advanced ENT and Allergy
name: Kenneth Hodge, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Piedmont Ear, Nose and Throat Associates
name: Kenneth S Maxwell, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Head and Neck Surgery Specialists
name: Woo Linda, MD
role: PRINCIPAL_INVESTIGATOR
References: