Comparison on Efficacy between Itraconazole and Terbinafine in the Treatment of Cutaneous Dermatophytosis

Abstract

The increasing burden of dermatophytosis has been observed all over the world. The vast numbers of hidden and undiagnosed cases remain untreated and these patients act as reservoirs and reinfect their surroundings, contributing to communal infection, a significant threat to the community. This randomized clinical trial was conducted to compare efficacy & safety between Itraconazole and Terbinafine in the treatment of cutaneous dermatophytosis, in the Department of Pharmacology and Therapeutics at Rajshahi Medical College, Rajshahi in collaboration with department of Dermatology & Venereology at Rajshahi Medical College Hospital, Rajshahi and Bangabandhu Sheikh Mujib Medical University (BSMMU), Dhaka, Bangladesh from July 2021 to June 2022. The study was conducted after obtaining ethical clearance from the Institutional Review Board (IRB) of Rajshahi Medical College and consent from the patients. Based on predefined eligibility criteria, a total number of 180 patients with dermatophytosis were included in the study. The study population was divided into two groups (Group-A and Group-B) on the basis of drug allocation. In Group-A, 90 patients were treated with Itraconazole at a dose of 5 mg/kg/day (study group) and in Group-B 90 patients were treated with Terbinafine at a dose of 3–6 mg/kg/day (control group) for 6 weeks. Erythema, scaling and pruritus were measured initially at baseline and again at the end of the 3rd and 6th week of drug administration. The overall reduction of mean erythema, scaling and pruritus from baseline to the 2nd follow-up of drug administration was more in Itraconazole group than Terbinafine group and it was statistically significant (p < 0.001, p=0.003 and p=0.001, respectively). The cure rate was 62.20% in Itraconazole group and 28.90% in Terbinafine group. Two weeks after cure, the relapse rates were 8.93% and 30.77%, respectively in the Itraconazole and Terbinafine groups. The findings of the study showed that Itraconazole is a better antifungal drug in comparison to Terbinafine (p < 0.05).