A Randomized, Double-blind, Placebo-controlled, Multi-Center Trial of Zinc for the Treatment of Herpes Simplex Labialis (HSL)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 157
- 试验地点
- 3
- 主要终点
- Zicam Was Compared to Placebo as a Treatment of Recurrent HSL From the Date and Time of the Initiation of Therapy Until the Date and Time of Resolution of the Lesion or After 14 Days of Treatment, Whichever Comes First.
研究概览
简要总结
Evaluate the effectiveness of a topical preparation of zinc to treat cold sores.
详细描述
Zinc salts irreversibly inhibit herpes virus replication in vitro and are effective in treating herpes infections in vivo and have been shown in a clinical trial to be a effective topical treatment for HSL. Zinc salt solutions applied to herpetic lesions decrease viral load and markedly improve healing rates, relieving the symptoms of herpes as healing occurs. Zinc swabs contain 33 mmol/l of ionic Zinc in an emulsification of Benzalkonium chloride, glycerin, hydroxyethylcellulose, sodium chloride, and sodium hydroxide (ph 7.2). Zinc gluconate is monographed in the Homeopathic Pharmacopoeia of the United States (HPUS) and one of OTC indications for Zinc and its salts is for the treatment of cold sores.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with a history of HSL with at least 2 episodes/year for the past two years that have proceeded beyond the prodromal (initial) stage
- •Male or female subjects between 18 and 65 years of age
- •Symptoms or signs of HSL for less than one day (max. 36 hours from onset of symptoms to first visit)
- •Confirmation of HSL by a clinician at the study site
- •Willing to comply with study instructions and sign an informed consent
排除标准
- •HSL symptoms or signs for more than one day
- •Cold sore outbreak within the past 2 weeks
- •Previous participation in this clinical trial
- •Topical or oral antiviral drug use in the past 1 week
- •Immune deficiency (HIV positive), chronic steroid therapy, present anti-neoplastic or radiation therapy, Hodgkin's disease, splenectomy, leukemia, myeloma, lymphoma, or another condition/drug per judgment of attending health care professional) or currently taking immune suppressive drugs. Previous organ or bone marrow transplant.
- •Pregnancy or lactation
- •Unable to travel to the clinic area for the required visits
- •Apparent inability to understand or follow the instructions associated with the clinical study
- •History of adverse events to the study material or facial cosmetics
研究组 & 干预措施
Zinc gluconate
Oral swabs containing homeopathic Zinc gluconate
干预措施: Zicam (Ionic zinc) (Drug)
Placebo
placebo
干预措施: placebo (Drug)
结局指标
主要结局
Zicam Was Compared to Placebo as a Treatment of Recurrent HSL From the Date and Time of the Initiation of Therapy Until the Date and Time of Resolution of the Lesion or After 14 Days of Treatment, Whichever Comes First.
时间窗: 14 days
Zinc gluconate swabs were compared as a treatment of recurrent HSL compared to placebo from the date and time of the initiation of therapy until the date and time of resolution of the lesion or after 14 days of treatment, whichever comes first.
次要结局
- Compare Zicam to Placebo on the Incidence of, Speed of, and the Rate of Healing for Aborted Cold Sore Lesions.(14 days)