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…
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Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design.
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