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.

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.

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

Baseline participants from ITT population which consisted of subjects entered and randomized, by randomized group. ITT population includes MITT population.

The study duration for each subject was up to 30 days (up to 14 days of treatment, and 8 days of follow-up, including the visit window of up to 8 additional days after the scheduled day to complete the final visit), starting from entry and randomization in the study. Start at Screening Visit and ends at final visit which is the Test of cure visit.

AEs were recorded and classified using MedDRA terminology. All treatment-emergent adverse events (TEAEs), defined as any AE with onset on or after date of first study drug application, summarized by drug group, number of subjects reporting TEAE, system organ class, preferred term, severity, relationship to study drug, and seriousness. Each subject counted once within a system organ class or preferred term using event with the highest severity and greatest relationship within each classification.

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.