Safety and Efficacy of Oral Itraconazole versus Combination with Oral Isotretinoin in Superficial Dermatophytosis: A Randomised Clinical Trial
WC01-WC05
Correspondence
Dr. Deepika Agarwal,
202, Scotia Tower 5, Omaxe Heights, Vibhuti Khand, Gomti Nagar, Lucknow-226010, Uttar Pradesh, India.
E-mail: dr.deepika2009@gmail.com
Introduction: Dermatophytes are the most common skin infections and are 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 in conjunction with itraconazole to manage dermatophytosis.
Aim: To evaluate the safety and efficacy of oral itraconazole versus a combination of oral isotretinoin and oral itraconazole in the treatment and prevention of recurrence of superficial dermatophytosis.
Materials and Methods: A randomised clinical trial was conducted in the Dermatology Outpatient Department (OPD) of the Hind Institute of Medical Sciences, Barabanki district of Uttar Pradesh over a 12-month period. A total of 180 adult patients clinically diagnosed with superficial dermatophytosis were recruited and randomised into groups 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 every 15 days for two months, and then followed-up for an additional two months to assess the relapse rate. Treatment efficacy was assessed by potassium hydroxide (KOH) test done on skin scrapings, erythema score, scaling score, and a 5D pruritus scale, while safety was evaluated by monitoring adverse reactions at each sequential visit during the two-month study period. The data were analysed using Chi-square tests and unpaired t-tests and Statistical Package for the Social Sciences (SPSS) software version 26.0, with a p-value <0.05 considered significant.
Results: Of the 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, compared with 74/83 (89.2%) in group A (p=0.06), with a significantly lower recurrence rate (p=0.01). At each follow-up, both groups were assessed based on the clinical signs of erythema and scaling, rated on a 4-point scale (0, 1, 2, 3), and the clinical symptom of itching on a 5D pruritus scale ranging from 5-25. There was a statistically significant difference in the treatment response between the 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 the management of superficial dermatophytosis, as it induces early remission with a significantly lower recurrence rate.