Terbinafine Hydrochloride for the Treatment of Otomycosis

Otomycosis is a common fungal infection of the external auditory canal. It is often associated with itching, ear blockage, tinnitus, pain, and hearing loss. Diagnosis is made clinically and confirmed by the presence of fungal growth on culture. Aspergillus species are the most frequent pathogens, but Candida species are also common.

Terbinafine hydrochloride is an antifungal drug from the allylamine class. It acts by inhibiting squalene epoxidase, an enzyme necessary for fungal cell membrane synthesis. Although terbinafine is not the first-line treatment for otomycosis, laboratory studies have shown it to be effective against Aspergillus and Candida, suggesting a potential role in therapy.

This single-arm, interventional clinical trial will include 50 patients diagnosed with otomycosis. Eligible participants will undergo full history and otoscopic examination. Ear swabs will be obtained before and after treatment for fungal culture. The intervention consists of applying terbinafine hydrochloride cream on an ear pack, which will be inserted into the ear canal. Packs will be replaced every two days for two weeks. Clinical follow-up will be performed at two weeks, and improvement will be assessed both by symptom relief and microbiological eradication.

The primary outcome is the percentage of patients who improve after terbinafine treatment. Secondary outcomes include symptom reduction and treatment safety. Data will be collected and analyzed using SPSS software. This study is approved by the Ethics Committee of the Faculty of Medicine, Assiut University. All patients will provide written informed consent prior to participation.

Inclusion criteria

• Age ≥ 18 years (male or female).

Clinical diagnosis of otomycosis (presence of itching, ear discharge, ear canal debris, or fungal mass on otoscopic exam).

Confirmation of fungal infection by direct microscopy (KOH preparation) and/or culture.

Willingness to comply with study procedures and follow-up visits.

Provided written informed consent.

Exclusion criteria

• Age < 18 years.

Bacterial otitis externa, mixed bacterial-fungal infection, or chronic suppurative otitis media.

History of ear surgery or tympanic membrane perforation.

Use of systemic or topical antifungal agents within the last 2 weeks.

Known hypersensitivity or allergy to terbinafine or excipients of the study drug.

Immunocompromised patients (e.g., HIV/AIDS, chemotherapy, uncontrolled diabetes mellitus).

Pregnant or breastfeeding women.

Patients unable or unwilling to provide informed consent or adhere to treatment protocol.