Efficacy and Safety of Oral Terbinafine with Itraconazole or Griseofulvin Combination Therapy in the Management of Dermatophytosis- A Randomised Clinical Trial

Introduction: Dermatophytosis is a common fungal infection caused by Trichophyton, Epidermophyton, Microsporum species. Combination of systemic and topical antifungal therapy is in vogue for all patients with dermatophytosis, except in cases of localised naïve Tinea. Recently, a rising prevalence of poor response to standard regimen of treatment has been noted. In this study, we tried to find out the benefits and adverse effects of systemic antifungal combination therapy in the treatment of tinea.

Aim: To compare the efficacy of oral terbinafine with itraconazole or griseofulvin combination therapy in the management of dermatophytosis and to assess the adverse effects associated with these combination therapies.

Materials and Methods: The present randomised clinical trial comprised of 60 patients with dermatophytosis who were divided into two groups. The study was conducted in the Department of Dermatology, Outpatient Department (OPD), Rajiv Gandhi Government General Hospital, Chennai, Tamil Nadu, India, from December 2020 to May 2021. Group I was treated with terbinafine 250 mg OD and itraconazole 200 mg OD and group II with terbinafine 250 mg OD with griseofulvin 250 mg BD for a period of four weeks and the patients were followed-up every two weeks with appropriate investigations. Outcome of the treatment was assessed at four weeks and eight weeks. Statistical analysis was done using Statistical Package for the Social Sciences (SPSS) version 16.0. Descriptive analyses were performed to compare the baseline characteristics of the participants between the two study groups. Student t-test was applied to compare the mean values of quantitative variables. Chi-square test was used for analysing the categorical variables. A p-value of <0.05 was considered as significant.

Results: Itraconazole containing group reported a better clinical cure rate than the griseofulvin containing group (p<0.05). Neither of the combination showed effectiveness against tinea infections pretreated with topical steroid containing formulations.

Conclusion: Combination of terbinafine with itraconazole produce higher clinical cure rate as compared to the combination of terbinafine with griseofulvin; but the percentage of clinical cure rate is less as compared to published studies in the past. Neither of the combination of systemic antifungals has shown efficacy against tinea infections pretreated with topical steroid containing formulations.