Tomić Ivona, Miočić Sandra, Pepić Ivan, Šimić Dubravka, Filipović-Grčić Jelena
Faculty of Pharmacy, University of Mostar, Matice hrvatske bb, 88000 Mostar, Bosnia and Herzegovina.
R&D, PLIVA Croatia Ltd., TEVA Group Member, Prilaz baruna Filipovića 25, 10000 Zagreb, Croatia.
Pharmaceutics. 2021 Apr 16;13(4):567. doi: 10.3390/pharmaceutics13040567.
Acne vulgaris is a common, multifactorial, inflammatory skin disease affecting the pilosebaceous unit. Topical therapy is the first choice in the treatment of mild to moderate acne, and azelaic acid (AZA) is one of the most commonly used drugs. The aim of this study was to evaluate the safety and efficacy of a low-dose azelaic acid nanocrystal (AZA-NC) hydrogel in the treatment of mild to moderate facial acne. The study was designed as a double-blind, randomized controlled trial. Patients were randomized to treatment with AZA-NC hydrogel, 10%, or AZA cream, 20%, administered in quantities of approximately 1 g twice daily for 8 weeks. Efficacy of therapy was measured by the number of lesions and safety by the frequency and severity of adverse events. At week 8, the success rate of treatment with AZA-NC hydrogel, 10%, was 36.51% ( < 0.001) versus 30.37% ( < 0.001) with AZA cream. At week 8, treatment with AZA-NC hydrogel, 10%, resulted in a significant reduction in total inflammatory lesions from baseline of 39.15% ( < 0.001) versus 33.76% ( < 0.001) with AZA cream, and a reduction in non-inflammatory lesions from baseline of 34.58% ( < 0.001) versus 27.96% ( < 0.001) with AZA cream, respectively. The adverse event rate was low and mostly mild.
寻常痤疮是一种常见的、多因素的炎症性皮肤病，累及毛囊皮脂腺单位。局部治疗是轻至中度痤疮治疗的首选，壬二酸（AZA）是最常用的药物之一。本研究的目的是评估低剂量壬二酸纳米晶体（AZA-NC）水凝胶治疗轻至中度面部痤疮的安全性和有效性。该研究设计为双盲、随机对照试验。患者被随机分为两组，分别接受10%的AZA-NC水凝胶或20%的AZA乳膏治疗，每天两次，每次约1 g，持续8周。通过皮损数量评估治疗效果，通过不良事件的频率和严重程度评估安全性。在第8周时，10%的AZA-NC水凝胶治疗成功率为36.51%（<0.001），而AZA乳膏为30.37%（<0.001）。在第8周时，10%的AZA-NC水凝胶治疗使总炎症性皮损较基线显著减少39.15%（<0.001），而AZA乳膏为33.76%（<0.001）；非炎症性皮损较基线分别减少34.58%（<0.001）和27.96%（<0.001）。不良事件发生率低，且大多为轻度。
