Randomized control trial of itraconazole in the treatment of dermatophytosis: comparison of three different dose regimens

Abstract

Introduction: Dermatophytosis is a superficial fungal infection of keratinized tissue caused by dermatophytes. The use of itraconazole in the standard dose and duration is commonly resulting in treatment failure. Aims and Objectives: To compare the efficacy and safety of three different dosage regimens of itraconazole in the treatment of dermatophytosis. Materials and Methods: Patients were enrolled and randomly assigned to three different groups A, B, and C after obtaining the proper consent. For four weeks, patients in Groups A, B, and C received itraconazole 100 mg once daily, 200 mg once daily, and 5 mg/kg or 400 mg daily, whichever was lesser, in two divided doses, respectively. All patients were advised to use topical eberconazole cream twice daily and levocetirizine 5 mg daily. Potassium hydroxide (KOH), culture for fungus, complete blood count (CBC), and liver function test (LFT) were done at the baseline visit and repeated in 4 weeks. A clinical assessment was done at both visits. Result: KOH was negative for fungal elements in 21.4%, 19%, and 17% of patients in groups A, B, and C respectively, after the completion of therapy. The culture was negative for fungal elements in 19%, 17.5%, and 19.5% of patients in groups A, B, and C respectively, post-therapy. At the end of four weeks, there was a statistically significant decrease in lesion count, body surface area involvement, erythema, and itching within all three groups. However, after 4 weeks of therapy, there was no significant difference in clinical outcome or mycological status among the three groups. Conclusion: Our study concludes that the higher dose of itraconazole does not prove to be more efficacious and has no added advantage over the conventional dose in the treatment of dermatophytosis at the end of four weeks. Therefore, we suggest for long-term (more than 4 weeks) itraconazole therapy with the conventional dose to achieve an adequate cure.