Hazan Lydie, Berg Jeffrey E, Bowman James P, Murray John V, Ryan William G
AXIS Clinical Trials, Los Angeles, California, USA.
Pediatr Dermatol. 2013 May-Jun;30(3):323-8. doi: 10.1111/pde.12033. Epub 2012 Nov 7.
The safety of a novel 0.5% ivermectin lotion (IVL) and potential for ivermectin absorption after application was investigated in an open-label study in young children, and a human repeat insult patch test (HRIPT) and cumulative irritation test (CIT) assessed any potential for cumulative dermal irritation and contact sensitization. In the pharmacokinetic and safety study, 30 head louse-infested children ages 6 months to 3 years received a 10-minute application of IVL on day 1. Blood was collected before application; 0.5, 1, and 6 hours after rinsing; and on days 2 and 8. Samples from 20 subjects were assayed for ivermectin (test sensitivity 0.05 ng/mL). Liver panel and complete blood counts were completed for all subjects. For the HRIPT/CIT, occlusive patches containing IVL or vehicle control lotion (CL) were repeatedly applied to 220 healthy adult subjects to assess contact sensitization; for cumulative dermal irritation testing, additional patches with normal saline and sodium dodecyl sulfate (SDS) were applied to 36 subjects. In the open-label study, all detected ivermectin plasma concentrations were <1 ng/mL. No safety signals emerged, and treatment was well tolerated. In the HRIPT/CIT, IVL was significantly less irritating than normal saline and SDS, with no evidence of dermal irritation or sensitization in human skin. IVL was safe when applied topically, absorption was de minimus, there was no evidence of irritation or sensitization from repeated exposures, and results support the safety of topical IVL use in children as young as 6 months.
在一项针对幼儿的开放标签研究中,对新型0.5%伊维菌素洗剂(IVL)的安全性及用药后伊维菌素的吸收潜力进行了研究,并通过人体重复刺激斑贴试验(HRIPT)和累积刺激试验(CIT)评估了累积皮肤刺激和接触致敏的可能性。在药代动力学和安全性研究中,30名6个月至3岁的头虱感染儿童在第1天接受了10分钟的IVL涂抹。在用药前、冲洗后0.5、1和6小时以及第2天和第8天采集血液。对20名受试者的样本进行伊维菌素检测(检测灵敏度为0.05 ng/mL)。对所有受试者进行肝功能检查和全血细胞计数。对于HRIPT/CIT,将含有IVL或赋形剂对照洗剂(CL)的封闭性斑贴反复应用于220名健康成人受试者以评估接触致敏情况;对于累积皮肤刺激试验,将含有生理盐水和十二烷基硫酸钠(SDS)的额外斑贴应用于36名受试者。在开放标签研究中,所有检测到的伊维菌素血浆浓度均<1 ng/mL。未出现安全信号,治疗耐受性良好。在HRIPT/CIT中,IVL的刺激性明显低于生理盐水和SDS,在人体皮肤中没有皮肤刺激或致敏的证据。局部应用IVL是安全的,吸收极少,反复接触没有刺激或致敏的证据,结果支持在6个月大的儿童中局部使用IVL的安全性。