Terbinafine Hydrochloride for the Treatment of Otomycosis

Otomycosis is a fungal infection of the ear that often causes itching, pain, ear discharge, and hearing problems. It is more common in hot and humid climates and in people with risk factors such as diabetes, frequent use of antibiotic ear drops, or swimming in polluted water. Standard treatments include antifungal ear drops, but relapses are frequent. This study will evaluate the effectiveness of terbinafine hydrochloride cream, an antifungal medication, in treating otomycosis. Terbinafine is known to be active against fungi such as Aspergillus and Candida, which are common causes of ear fungal infections. In this study, patients with otomycosis will have terbinafine hydrochloride cream applied on an ear pack that will be placed in the ear canal and changed every two days for two weeks. The main goal of the study is to find out whether terbinafine hydrochloride is effective in reducing symptoms and eradicating the fungal infection. Patients will be examined clinically and ear swabs will be tested before and after treatment. The study will be conducted at Assiut University Hospital and Assiut General Hospital in Egypt, and about 50 patients are expected to participate.

NCT Number	NCT07152327
Lead Sponsor	Assiut University
Conditions	Otomycosis, Fungal Ear Infection
Enrollment	50 participants
Start Date	2025-10-01
Primary Completion	2026-10-01 (estimated)
Study Completion	2026-12-01 (estimated)
Updated on ClinicalTrials.gov	2025-10-01