Efficacy of ketoconazole ear wash versus conventional topical antifungal therapy in otomycosis: a prospective randomized controlled trial

Abstract

Background: Otomycosis is a common fungal infection of the external auditory canal, especially in warm, humid areas. Although topical antifungal medications are widely used, the best course of action is still up for debate, and recurrence is frequently reported. Although there is little clinical data to support the use of ketoconazole as an ear wash, it is a broad-spectrum azole antifungal with demonstrated in vitro action against common fungal infections. Aim: To evaluate the efficacy of ketoconazole ear wash in the management of otomycosis compared with conventional dry aural toilet followed by topical antifungal cream application. Participants and methods: This prospective randomized controlled interventional study included 200 patients with clinically confirmed unilateral otomycosis who visited the ENT outpatient clinic at Damietta Specialized Hospital, Egypt between June 2024 and June 2025 were included in this prospective randomized controlled interventional trial. Patients were randomly allocated into two equal groups: Group A received conventional treatment (dry aural toilet followed by the application of topical broad-spectrum antifungal cream), while Group B received treatment 2% ketoconazole ear wash. For four weeks, Participants were followed up weekly. Clinical symptoms, otoscopic findings, microbiological swabs results, Visual Analogue Scale (VAS) scores, time to clinical resolution, and patient satisfaction were assessed. Results: Aspergillus species were the most commonly isolated organisms, and 30.8% of patients with otitis externa had otomycosis. Clinical symptoms, otoscopic findings, microbiological clearance, and VAS scores were significantly and gradually improved over time in both groups (p < 0.001). However, at every follow-up point, there were no statistically significant differences between the two groups (p > 0.05). Patient satisfaction and the time to clinical resolution were similar across the groups. Conclusion: When treating otomycosis, ketoconazole ear wash works just as well as traditional topical antifungal medication. The results imply that proper aural toilet, rather than the particular antifungal medication administered, is the main factor influencing treatment efficacy. In terms of patient compliance and convenience of application, ketoconazole ear wash might be a practical substitute.