Comparative Efficacy of Three Oral Itraconazole Formulations in Superficial Dermatophytosis.

IF 3.1 2区医学 Q1 DERMATOLOGY

Mycoses Pub Date : 2025-06-01 DOI:10.1111/myc.70080

Harsh Tyagi, Shitij Goel, Aneesha Puri, Isha Singla, Anmol Rathore

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引用次数: 0

Abstract

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.

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三种口服伊曲康唑制剂治疗浅表性皮肤癣的疗效比较。

在印度，皮肤真菌病是一种慢性公共卫生问题，通常需要全身抗真菌药物。伊曲康唑（Itraconazole， ITZ）是常用的，但传统形式的吸收变化较大。超生物可利用伊曲康唑（SUBA-ITZ）提供了改善的药代动力学，尽管临床比较有限。目的：比较常规ITZ 100 mg （C-ITZ）、SUBA-ITZ 65 mg、SUBA-ITZ 50 mg三种口服ITZ制剂治疗浅表性皮肤癣的疗效、安全性、复发率和复发率。方法：在一所三级医院进行的这项开放标签随机研究中，150名确诊为体癣、皮疹或面部癣的患者被平均分配到：a组：C- itz 100 mg BID B组：SUBA-ITZ 65 mg BID C组：SUBA-ITZ 50 mg BID治疗持续6周，不使用局部抗真菌药物。在第3周和第6周进行评估；在3个月和6个月时电话监测复发和复发情况。结果：6周时各组临床反应相似（BSA、PGA、KOH阴性），差异无统计学意义。3个月时，C组的复发和复发率（10.2%）明显低于B组（31.1%,28.9%）和A组（23.9%,26.1%）。(p)结论：三种伊曲康唑制剂治疗浅表性皮肤癣的短期疗效相当。这些发现强调需要更大规模的长期随机对照试验来优化伊曲康唑的给药策略。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Mycoses 医学-皮肤病学

CiteScore

10.00

自引率

8.20%

发文量

143

审稿时长

6-12 weeks

期刊介绍： The journal Mycoses provides an international forum for original papers in English on the pathogenesis, diagnosis, therapy, prophylaxis, and epidemiology of fungal infectious diseases in humans as well as on the biology of pathogenic fungi. Medical mycology as part of medical microbiology is advancing rapidly. Effective therapeutic strategies are already available in chemotherapy and are being further developed. Their application requires reliable laboratory diagnostic techniques, which, in turn, result from mycological basic research. Opportunistic mycoses vary greatly in their clinical and pathological symptoms, because the underlying disease of a patient at risk decisively determines their symptomatology and progress. The journal Mycoses is therefore of interest to scientists in fundamental mycological research, mycological laboratory diagnosticians and clinicians interested in fungal infections.