Department of Dermatology, Omega Hospital, Mangalore, Karnataka, India.
Department of Dermatology, Wizderm Specialty Skin and Hair Clinic, Kolkata, West Bengal, India.
Drug Des Devel Ther. 2023 Sep 21;17:2899-2908. doi: 10.2147/DDDT.S421583. eCollection 2023.
Itraconazole follows non-linear pharmacokinetics and hence is recommended once daily, but in real-world practice, is commonly prescribed as twice daily. Hence, this study aimed to evaluate the efficacy and safety of super-bioavailable-itraconazole-130 mg (SB-130) and conventional-itraconazole-200 mg (CITZ-200) once daily compared with conventional-itraconazole-100 mg (CITZ-100) twice daily in glabrous tinea.
A total of 261 eligible patients were enrolled in this prospective, randomized, clinical study from December-2021 to August-2022 at seven centers in India. Efficacy and safety assessments were done at week-3 and 6, with follow-up at week-10 for relapse. The primary objective was to assess the proportion of patients who achieved complete cure at week-6 following treatment in all itraconazole groups. The secondary outcomes were safety and clinical and mycological cure rates.
Of 261 patients, 240 were included in the analysis. At week-6, 140 patients were completely cured; thus, overall cure rate was 58.33%. Fifty-five patients (69%) in SB-130 while 47/77 (61%) and 38/83 (46%) patients were completely cured in CITZ-200 and CITZ-100 groups respectively (p<0.05; SB-130: CITZ-100, p=0.32; SB-130: CITZ-200, p=0.058; CITZ-200: CITZ-100). There was no statistical difference in the mycological cure rate and area clearance rate between any of the groups (p=0.14); however, a statistically significant difference was noted for OD dosing over BD dosing in achieving clinical cure rates (p<0.05). A total of 13/140 patients (9%) relapsed following complete cure, with no statistically significant difference between any of the groups (p=0.50). All treatments were safe and well-tolerated, with no discontinuation.
In this clinical study, moderate efficacy with all doses of ITZ was reported but was better with OD dosing. Although there was no statistical difference between SB-130 and CITZ-200, SB-130 may be preferred over CITZ-200 owing to the advantage of SB over the conventional ITZ.
伊曲康唑遵循非线性药代动力学，因此建议每日一次给药，但在实际临床实践中，通常每日两次给药。因此，本研究旨在评估每日一次使用高生物利用度伊曲康唑 130 毫克（SB-130）和每日两次使用常规伊曲康唑 200 毫克（CITZ-200）与每日两次使用常规伊曲康唑 100 毫克（CITZ-100）治疗无毛癣的疗效和安全性。
2021 年 12 月至 2022 年 8 月，在印度的 7 个中心共招募了 261 名符合条件的患者参与这项前瞻性、随机、临床研究。在第 3 周和第 6 周进行疗效和安全性评估，并在第 10 周进行随访以评估复发情况。主要目标是评估所有伊曲康唑组患者在治疗后第 6 周时完全治愈的比例。次要结局包括安全性和临床及真菌学治愈率。
在 261 名患者中，有 240 名患者纳入分析。在第 6 周时，有 140 名患者完全治愈，因此总治愈率为 58.33%。在 SB-130 组中，有 55 名患者（69%）完全治愈，而在 CITZ-200 组和 CITZ-100 组中，分别有 47/77（61%）和 38/83（46%）名患者完全治愈（p<0.05；SB-130：CITZ-100，p=0.32；SB-130：CITZ-200，p=0.058；CITZ-200：CITZ-100）。各组之间的真菌学治愈率和区域清除率无统计学差异（p=0.14）；然而，在实现临床治愈率方面，OD 剂量给药与 BD 剂量给药有统计学显著差异（p<0.05）。在完全治愈后，共有 13/140 名患者（9%）复发，各组之间无统计学差异（p=0.50）。所有治疗均安全且耐受良好，无停药。
在这项临床研究中，报告了所有伊曲康唑剂量的中等疗效，但 OD 剂量给药的疗效更好。虽然 SB-130 与 CITZ-200 之间没有统计学差异，但由于 SB 相对于常规 ITZ 的优势，SB-130 可能优于 CITZ-200。
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