A prospective, randomized, open label, comparative study of efficacy and tolerability of oral itraconazole versus combination therapy with oral itraconazole and oral terbinafine in treatment of dermatophytosis

Vollständiger Abstract

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Background: Superficial dermatophytosis, caused by fungi like Trichophyton and Microsporum, affects skin, hair and nails, presenting as round, red, scaly patches with itching. Generally, topical antifungals are common preferred treatment, while extensive infections and immunocompromised patients often require systemic oral treatments due to frequent relapses and resistance to topical terbinafine. This study compares itraconazole monotherapy with combination therapy of itraconazole and terbinafine to optimize treatment. Methods: The study was conducted at Kempe Gowda Institute of Medical Sciences Hospital & Research Centre, Bengaluru, the study included 152 clinical and 10% KOH smear confirmed superficial dermatophytosis patients. Participants were randomly assigned to Group A (77 received oral itraconazole 100 mg twice daily for 3 weeks) and Group B (75 received oral itraconazole 100 mg twice daily plus oral terbinafine 250 mg once daily for 3 weeks). Participants were followed -ups at 3, 6 and 9 weeks for symptoms, KOH smear test results, clinical response and rescue medication use. Results: Group B had a higher proportion of complete recoveries without relapse (p value 0.00775). No significant differences were found between the groups in terms of symptom severity, KOH test results, clinical response or rescue medication use, indicating comparable effectiveness. Conclusions: Combination therapy with itraconazole and terbinafine was more effective than itraconazole alone in achieving relapse-free recovery in dermatophytosis patients. Both regimens were well-tolerated, suggesting combination therapy as a potentially better approach for fungal infections. This study supports combination therapy as a cost-effective treatment for tinea infections.