AN OPEN, RANDOMIZED CLINICAL COMPARATIVE STUDY DETERMINING THE EFFICACY AND SAFETY OF ITRACONAZOLE VERSUS TERBINAFINE IN THE TREATMENT OF ONYCHOMYCOSIS.

Background: Onychomycosis,also known as tinea unguium,is a fungal infection of nail unit. Objective:To compare the efficacy and safety of itraconazole versus terbinafine in the treatment of onychomycosis. Study Design: An open, randomized,prospective clinical comparative study was done on 70 patients of onychomycosis attending skin OPD of SNMC Agra UP during the period from august 2019 to march 2021. 35 patients were randomly assigned to receive oral itraconazole 200mg once a day for 12weeks in group A and other 35 patients received oral terbinafine 250mg once a day for 12weeks in group B.The patients were evaluated at the start of the therapy and thereafter at 4,8,12,24 weeks. Results: In group A (Itraconazole), 62.85% of patients showed mycological cure and 51.43% of patients showed clinical cure.In group B (Terbinafine), 74.28% of patients showed mycological cure and 62.86% of patients showed clinical cure. The difference in cure rates between two groups was not statistically significant (p>0.05). Adverse effects were seen in 17.14% of patients in group A and 20% of patients in group B.None of these effects was significant enough to discontinue therapy. The difference in adverse effects between two groups was not statistically significant (p>0.05). Conclusion: Both itraconazole and terbinafine were equally effective and safe in the treatment of onychomycosis. Both drugs were well tolerated and were relatively free of major adverse effects.