Comparative evaluation of efficacy and safety of terbinafine and itraconazole in the management of tinea corporis et cruris

Abstract

Introduction: The management of dermatophytosis is challenging in India and there are reports of using systemic antifungals at higher doses. But there are multiple reports of increased treatment failures with terbinafine at standard dosage as well, hence we conducted this study to compare efficacy and safety of high dose of terbinafine with itraconazole at standard dose. Topical ciclopirox olamine was used in both arms. Materials and Methods: This was randomized, open label, comparative study where 80 patients with tinea corporis et cruris infection were included. Patients were either prescribed terbinafine 250mg twice a day or itraconazole 100mg twice a day for 4 weeks. Efficacy was assessed based on complete, clinical and mycological cure rate. Safety was assessed by evaluating adverse events and monitoring liver function of patients. Results: Total 76 patients completed the study with 38 in each group. 81.5% patients achieved complete cure in terbinafine group compared to 76.31% patients in itraconazole group. At the end of six weeks, there was a statistically significant improvement (p value<0.05) in the total symptom score (erythema, scaling, and pruritus) in Group I as well as in Group II compared to baseline. None of the patients showed any significant side effect in both Itraconazole and Terbinafine groups. No changes in liver function were observed in both the groups. Conclusion: This study shows that the high dose of terbinafine in combination with topical ciclopirox is effective and safe in management of tinea corporis et cruris.