背景:全球,大约90%的人感染了单纯疱疹病毒,30%的人会经历复发性单纯唇疱疹,通常被称为“冷疮”,可以持续10天。最常见的治疗是阿昔洛韦乳膏,与没有特殊治疗相比,它可以减少半天的愈合时间。这是一项随机对照试验(RCT)的协议,以确定医学级Kanuka蜂蜜为基础的局部治疗(Honevo)在减少唇疱疹的愈合时间和疼痛方面的疗效。与局部阿昔洛韦治疗(维拉班)相比。
方法:这个开放标签,平行组,主动比较优势RCT将在新西兰60个地点的药学研究网络中,比较医用级卡努卡蜂蜜与5%阿昔洛韦乳膏治疗唇疱疹的疗效。出现感冒疮的成年人(N=950)将由基于药房的研究人员随机分配。以药房为基础的研究人员将研究产品分配给随机参与者,两个研究组每天进行五次治疗,直到他们的皮肤恢复正常或持续14天。以先发生者为准。响应每日SMS消息,参与者完成了对感冒疮愈合的评估,参考视觉指南,并通过智能手机eDiary将其实时传输给调查人员。主要结果变量是从随机化到恢复正常皮肤的时间(以天为单位)。次要终点包括治疗开始时按病变阶段分层的总愈合时间。最高的疼痛严重程度和疼痛解决时间。
背景:新西兰伦理注册15/NTB/93。结果将发表在同行评审的医学杂志上,在学术会议上介绍并向与会者报告。
背景:澳大利亚新西兰临床试验注册:ACTRN12615000648527,预结果。SCOTT注册:15/SCOTT/14协议版本:4.0(2017年6月12日)。
BACKGROUND: Worldwide, about 90% of people are infected with the herpes simplex virus, 30% of whom will experience recurrent herpes simplex labialis, commonly referred to as \'cold sores\', which can last up to 10 days. The most common treatment is
aciclovir cream which reduces healing time by just half a day compared with no specific treatment. This is a protocol for a randomised controlled
trial (RCT) to determine the efficacy of medical grade kanuka honey-based topical treatment (Honevo) in reducing the healing time and pain of cold sores, compared with topical
aciclovir treatment (Viraban).
METHODS: This open-label, parallel-group, active comparator superiority RCT will compare the efficacy of medical grade kanuka honey with 5%
aciclovir cream in the treatment of cold sores in the setting of a pharmacy research network of 60 sites throughout New Zealand. Adults presenting with a cold sore (N=950) will be randomised by pharmacy-based investigators. The pharmacy-based investigators will dispense the investigational product to randomised participants and both
study groups apply the treatment five times daily until their skin returns to normal or for 14 days, whichever occurs first. In response to a daily SMS message, participants complete an assessment of their cold sore healing, with reference to a visual guide, and transmit it to the investigators by a smartphone eDiary in real time. The primary outcome variable is time (in days) from randomisation to return to normal skin. Secondary endpoints include total healing time stratified by stage of the lesion at onset of treatment, highest pain severity and time to pain resolution.
BACKGROUND: New Zealand Ethics Registration 15/NTB/93. Results will be published in a peer-reviewed medical journal, presented at academic meetings and reported to participants.
BACKGROUND: Australia New Zealand Clinical Trials Registry: ACTRN12615000648527, pre-results.SCOTT Registration: 15/SCOTT/14 PROTOCOL VERSION: 4.0 (12 June 2017).