Sertaconazole versus Clotrimazole and Miconazole Creams in the Treatment of Otomycosis: A Placebo-Controlled Clinical Trial

Introduction: Fungal otitis extern or otomycosis, is common worldwide, and resistance of fungal organisms to antifungal drugs has been reported in otomycosis and other fungal infections. This study aimed to evaluate the clinical efficacy of sertaconazole versus placebo, as well as miconazole and clotrimazole topical creams in otomycosis patients.

Materials and methods: In this double-blinded clinical trial, 138 otomycosis patients (230 ears) were evaluated in four groups. After the first session of the ear canal debridement and irrigation with acetic acid 2% solution, the patients were treated with either A) sertaconazole 2% cream, B) miconazole 2% cream, C) clotrimazole 2% cream, or D) placebo. The results of clinical evaluations and response to treatment (complete, partial, and no response) were recorded at the time of the first visit and by the end of the first, second, and fourth weeks of treatment. A p-value less than 0.05 was considered statistically significant.

Results: Response results to treatments, ear itching, aural fullness, otalgia, and otorrhea revealed significant differences in either group A or groups B and C, compared to the placebo group (P<0.05). Considering both complete and partial responses together, the sertaconazole group showed a 96.43% response rate. For complete response, miconazole revealed better results, compared to the other two creams; however, the differences for the therapeutic outcomes were not statistically significant. No adverse reactions were observed in the study groups.

Conclusions: Sertaconazole had comparable results with miconazole and clotrimazole in the treatment of otomycosis, and especially if complete and partial responses were considered together, it was more efficacious than miconazole and clotrimazole creams.