Effectiveness of Terbinafine Hydrochloride in the Treatment of Otomycosis: Basic and Clinical Evaluation

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.