Safety and Efficacy of Oral Itraconazole versus Combination with Oral Isotretinoin in Superficial Dermatophytosis: A Randomised Clinical Trial

Abstract

Introduction: Dermatophytes are the most common skin infections mainly treated with itraconazole. However, the persistent nature of the disease has emerged as the major concern over the last few years. Oral isotretinoin, a keratolytic drug is also used along with itraconazole in the management of dermatophytosis. Aim: To evaluate safety and efficacy of oral itraconazole versus combination with oral isotretinoin in the treatment and recurrence prevention of superficial dermatophytosis. Materials and Methods: The randomised clinical trial was conducted in the Dermatology Outpatient Department (OPD) of Hind Institute of Medical Sciences, Barabanki district of Uttar Pradesh over 12 months period. A total of 180 adult patients clinically diagnosed with superficial dermatophytosis were recruited and randomised into group A and B. Patients in group A were treated with oral itraconazole 200 mg daily and patients allotted in group B received oral itraconazole 200 mg plus oral isotretinoin 20 mg daily. Both groups were evaluated after every 15 days for two months and followed-up for next two months to assess relapse rate. Treatment efficacy was assessed by potassium hydroxide (KOH) test done on skin scrapings, erythema score, scaling score and 5D pruritus scale and safety by evaluating for adverse reactions noticed at each sequential visit during study period of two months. The data were analysed by using Chi-square tests and unpaired t-tests and Statistical Package for the Social Sciences (SPSS) software version 26.0. A p-value <0.05 was taken as significant. Results: Out of 180 patients enrolled, 162 patients (83 in group A and 79 in group B) completed the trial. The patients in group B had early and complete mycological cure, seen in 77/79 (97.5%) patients as compared with 74/83 (89.2%) group A patients (p=0.06) with significantly low recurrence rate (p=0.01). At each follow-up, both groups were assessed on the clinical signs of erythema and scaling rated on 4 points scale (0, 1, 2, 3) and clinical symptom of itching on 5D pruritus scale ranging from 5-25. There was statistically significant difference in the treatment response between studied groups (p<0.05). Hepatic derangements were the most common adverse effects observed in both groups. Conclusion: Oral isotretinoin can be an effective add on therapy in superficial dermatophytosis management as it induces early remission with significantly less recurrence rate.