NCT03130738

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 65 (actual)
• Sponsor: Hill Dermaceuticals, Inc. · Industry
• Sex: All
• Age: 25 Months
• Healthy volunteers: Not accepted

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.

Conditions

• Otomycosis

Interventions

Type	Name	Description
DRUG	7-Day Miconazole Oil (Miconazole 2%)	7 days of 2x per day treatment with Miconazole Oil (Active Drug Product 2% Miconazole)
DRUG	14-Day Miconazole Oil (Miconazole 2%)	14 days of 2x per day treatment with Miconazole Oil (Active Drug Product 2% Miconazole)
DRUG	14-Day Placebo - Oil Vehicle	14 days of 2x per day treatment with Placebo - Oil Vehicle, Study Drug base without active ingredient

Timeline

• Start date: 2017-04-20
• Primary completion: 2019-08-06
• Completion: 2019-08-06
• First posted: 2017-04-26
• Last updated: 2022-10-05
• Results posted: 2020-05-08

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated drug study