Hebert Adelaide A, Albareda Nuria, Rosen Theodore, Torrelo Antonio, Grimalt Ramon, Rosenberg Noah, Zsolt Ilonka, Masramon Xavier
J Drugs Dermatol. 2018 Oct 1;17(10):1051-1057.
Ozenoxacin is a novel topical antibacterial agent with potent bactericidal activity against Gram-positive bacteria that has been developed as a 1% cream for treatment of impetigo. This article presents pooled results of pivotal clinical trials of ozenoxacin with the objective of evaluating the efficacy, safety, and tolerability of ozenoxacin 1% cream after twice-daily topical treatment for 5 days in patients with impetigo. A pooled analysis was performed of individual patient data from two multicenter, randomized, double-blind, vehicle-controlled phase 3 registration studies conducted in patients with impetigo. Both clinical trials followed a similar methodology. Patients were randomized 1:1 to ozenoxacin or vehicle. One trial included retapamulin as an internal control. Efficacy was measured using the Skin Infection Rating Scale and microbiological culture. Safety and tolerability were evaluated. Ozenoxacin demonstrated superior clinical success versus vehicle after 5 days of therapy, superior microbiological success versus vehicle after 2 days of therapy, and was safe and well-tolerated. Ozenoxacin showed superior clinical and microbiological response versus vehicle in children as young as 2 months of age, and adults, with impetigo. Clinical Trial Registration: ClinicalTrials.gov identifier: NCT01397461 and NCT02090764; European Clinical Trials Database Number: 2011-003032-31 and 2014-000228-52. J Drugs Dermatol. 2018;17(10):1051-1057.
奥昔沙星是一种新型外用抗菌剂，对革兰氏阳性菌具有强大的杀菌活性，已开发出1%乳膏用于治疗脓疱病。本文介绍了奥昔沙星关键临床试验的汇总结果，目的是评估1%奥昔沙星乳膏在脓疱病患者中每日两次局部治疗5天后的疗效、安全性和耐受性。对两项在脓疱病患者中进行的多中心、随机、双盲、赋形剂对照3期注册研究的个体患者数据进行了汇总分析。两项临床试验均采用类似方法。患者按1:1随机分为奥昔沙星组或赋形剂组。一项试验将瑞他帕林作为内部对照。使用皮肤感染评定量表和微生物培养来测量疗效。评估安全性和耐受性。治疗5天后，奥昔沙星在临床疗效上优于赋形剂，治疗2天后，在微生物学疗效上优于赋形剂，且安全、耐受性良好。奥昔沙星在2个月大的儿童和患有脓疱病的成人中，在临床和微生物学反应方面均优于赋形剂。临床试验注册：ClinicalTrials.gov标识符：NCT01397461和NCT02090764；欧洲临床试验数据库编号：2011-003032-31和2014-000228-52。《皮肤药物学杂志》。2018年；17(10):1051-1057。
