INTRODUCTION Herpes simplex labialis (HSL) is a common infection that can cause painful lesions on the oral mucosa, commonly referred to as cold sores. Current biomedical treatments include topical aciclovir, which reduces the episode duration by an average of 0.5 days. This study will examine the efficacy and tolerability of an over-the-counter topical treatment, Dynamiclear in reducing duration and severity of HSL episodes. METHODS AND ANALYSIS This prospective, randomised, double-blind, placebo-controlled, multi-centre trial will recruit a minimum of 292 adult participants across Australia and New Zealand who present with a cold sore within 48 hours of onset. They will be randomly allocated in a 2:1 ratio to receive either topical Dynamiclear (active) or placebo. Dynamiclear's active ingredients are Hypericum perforatum, Calendula Officinalis and copper sulfate. A single topical treatment of active or placebo will be applied by a pharmacy-based investigator, and participants will be provided with a viral swab kit to confirm presence of herpes virus 1 or 2 from ulcerated lesions. Participants will receive reminders by email and/or SMS to complete an online daily diary assessing their cold sore lesion using a visual guide, and recording other symptoms on numeric scales until healed. The primary outcome variable is median duration of HSL episode in days (participant evaluated) from presentation to return to normal skin. Secondary outcomes include severity of lesion pain, itching, burning and tingling during the symptomatic phase and proportion of lesions progressing to ulceration. ETHICS AND DISSEMINATION Australian ethics approval from Western Sydney University Human Research Ethics Committee, ref: H12776. New Zealand Ethics approval from The Health and Disability Ethics Committees (HDEC) ref: 18/CEN/151. Results will be published in a peer-reviewed academic journal, presented at academic meetings and reported to participants TRIAL REGISTRATION NUMBERS: Australia and New Zealand Clinical Trials Registry (ACTRN12618000890235); Universal Trial Number (UTN) (U1111-1233-2426).

中文翻译：

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在社区环境中局部用草药和矿物质制剂（Dynamiclear）治疗单纯性唇疱疹的功效：一项随机，双盲安慰剂对照试验的研究方案。

简介单纯性唇疱疹（HSL）是一种常见的感染，可引起口腔粘膜上的疼痛性病变，通常称为唇疱疹。当前的生物医学治疗方法包括局部用药阿昔洛韦，平均可将发作持续时间缩短0.5天。这项研究将检查非处方局部治疗药Dynamiclear在减少HSL发作的持续时间和严重程度方面的功效和耐受性。方法与分析该前瞻性，随机，双盲，安慰剂对照，多中心试验将在澳大利亚和新西兰征集至少292名在发病48小时内出现唇疱疹的成人受试者。他们将以2：1的比例随机分配，以接受局部Dynamiclear（有效）或安慰剂。Dynamiclear的有效成分是贯叶连翘，金盏菊和硫酸铜。基于药房的研究人员将对活性剂或安慰剂进行单次局部治疗，并向参与者提供病毒拭子套件，以确认溃疡性病变中是否存在疱疹病毒1或2。参与者将通过电子邮件和/或SMS收到提醒，以完成在线每日日记，使用视觉指南评估他们的唇疱疹病变，并以数字量表记录其他症状直至until愈。主要的结果变量是从表现到恢复正常皮肤的天数（评估参与者）的HSL发作持续时间的中位数。次要结果包括症状期的病变疼痛，瘙痒，灼热和刺痛的严重程度，以及病变发展为溃疡的比例。道德与传播西悉尼大学人类研究伦理委员会批准了澳大利亚伦理，编号：H12776。健康与残疾伦理委员会（HDEC）的新西兰伦理批准，编号：18 / CEN / 151。研究结果将发表在同行评审的学术期刊上，并在学术会议上进行介绍并报告给参与者。试验注册号：澳大利亚和新西兰临床试验注册（ACTRN12618000890235）；通用试验编号（UTN）（U1111-1233-2426）。澳大利亚和新西兰临床试验注册处（ACTRN12618000890235）；通用试验编号（UTN）（U1111-1233-2426）。澳大利亚和新西兰临床试验注册处（ACTRN12618000890235）；通用试验编号（UTN）（U1111-1233-2426）。