Comparative Efficacy and Safety of Super Bioavailable Itraconazole versus Conventional Itraconazole in the Treatment of Cutaneous Fungal Infections: A Study in A Tertiary Care Hospital, Cumilla, Bangladesh

Open Access

Abstract

Background: Itraconazole is a widely used triazole antifungal agent for the treatment of superficial and systemic fungal infections. However, conventional itraconazole (C-ITZ) exhibits variable and often unpredictable oral bioavailability due to its dependence on gastric acidity, food intake and formulation characteristics. These limitations may result in subtherapeutic drug levels and treatment failure. SUBA-itraconazole (Super BioAvailable itraconazole; S-ITZ) is a novel formulation developed to enhance absorption and achieve more consistent plasma concentrations, independent of gastric pH. Objective: To compare the clinical efficacy, mycological cure rates, safety and tolerability of SUBA-itraconazole with conventional itraconazole in routine clinical practice. Methods & Materials: This prospective, open-label, comparative study was conducted in the Department of Dermatology and Venereology at Cumilla Medical College Hospital, Cumilla, Bangladesh, over a 12-month period from January 2024 to December 2024. A total of 100 adult patients with clinically and mycologically confirmed fungal infections were enrolled. Patients were equally divided into two groups: Group A received SUBA-itraconazole 65 mg twice daily, while Group B received conventional itraconazole 100 mg twice daily. Patients were evaluated at baseline and followed up at 4, 6, and 8 weeks. Clinical cure, mycological cure, time to symptom resolution, adverse events and liver and renal function parameters were assessed at each follow-up visit. Results: The SUBA-itraconazole group demonstrated a significantly higher complete clinical cure rate (88% vs. 68%) and mycological cure (86% vs. 66%). Patients treated with SUBA-itraconazole experienced faster symptom resolution (12.4 ± 3.1 days) compared to conventional itraconazole (18.7 ± 4.6 days). Adverse events were mild and comparable between groups. Conclusion: SUBA-itraconazole demonstrated superior clinical and mycological efficacy with faster symptom relief and a safety profile comparable to conventional itraconazole. Its improved and predictable bioavailability makes it a preferable therapeutic option for the management of fungal infections in routine clinical practice.