Mycoses · 2025
Comparative Efficacy of Three Oral Itraconazole Formulations in Superficial Dermatophytosis.
СтатьяРандомизированное исследованиеСравнительное исследованиеНазвание и аннотация: Перевод в очереди
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Tyagi Harsh, Goel Shitij, Puri Aneesha, Singla Isha, Rathore Anmol
Аннотация
INTRODUCTION: Dermatophytosis is a chronic public health issue in India, often requiring systemic antifungals. Itraconazole (ITZ) is commonly used, but conventional forms show variable absorption. Super-bioavailable itraconazole (SUBA-ITZ) offers improved pharmacokinetics, though clinical comparisons are limited.
OBJECTIVE: To compare the efficacy, safety, relapse, and recurrence rates of three oral ITZ formulations-Conventional ITZ 100 mg (C-ITZ), SUBA-ITZ 65 mg, and SUBA-ITZ 50 mg-in superficial dermatophytosis.
METHODS: In this open-label, randomised study at a tertiary hospital, 150 patients with confirmed tinea corporis, cruris, or faciei were equally assigned to: Group A: C-ITZ 100 mg BID Group B: SUBA-ITZ 65 mg BID Group C: SUBA-ITZ 50 mg BID Treatment lasted 6 weeks without topical antifungals. Assessments were done at 3 and 6 weeks; relapse and recurrence were monitored telephonically at 3 and 6 months.
RESULTS: All groups showed similar clinical response at 6 weeks (BSA, PGA, KOH negativity), with no significant differences. At 3 months, Group C had significantly lower relapse and recurrence (10.2%) than Group B (31.1%, 28.9%) and Group A (23.9%, 26.1%) (p < 0.05). By 6 months, differences were not significant.
CONCLUSION: All three itraconazole formulations demonstrated comparable short-term efficacy in treating superficial dermatophytosis. These findings underscore the need for larger, long-term randomised controlled trials to optimise itraconazole dosing strategies.
OBJECTIVE: To compare the efficacy, safety, relapse, and recurrence rates of three oral ITZ formulations-Conventional ITZ 100 mg (C-ITZ), SUBA-ITZ 65 mg, and SUBA-ITZ 50 mg-in superficial dermatophytosis.
METHODS: In this open-label, randomised study at a tertiary hospital, 150 patients with confirmed tinea corporis, cruris, or faciei were equally assigned to: Group A: C-ITZ 100 mg BID Group B: SUBA-ITZ 65 mg BID Group C: SUBA-ITZ 50 mg BID Treatment lasted 6 weeks without topical antifungals. Assessments were done at 3 and 6 weeks; relapse and recurrence were monitored telephonically at 3 and 6 months.
RESULTS: All groups showed similar clinical response at 6 weeks (BSA, PGA, KOH negativity), with no significant differences. At 3 months, Group C had significantly lower relapse and recurrence (10.2%) than Group B (31.1%, 28.9%) and Group A (23.9%, 26.1%) (p < 0.05). By 6 months, differences were not significant.
CONCLUSION: All three itraconazole formulations demonstrated comparable short-term efficacy in treating superficial dermatophytosis. These findings underscore the need for larger, long-term randomised controlled trials to optimise itraconazole dosing strategies.