A Randomized, Double-blind, Parallel, Placebo-controlled Study for the Assessment of the Safety and Efficacy of BTL-TML-HSV for the Treatment of Recurrent Symptomatic Oral Herpes Virus Infection
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 171
- 试验地点
- 4
- 主要终点
- Proportion of Subjects Who Experience a New Cold Sore Outbreak That Proceeds to the Lesion Stage. Of Those Subjects That Take Study Medication (Experience a New Emerging Cold Sore) Those That Proceed to Lesion Stage (Cold Sore Stage - 3 Vesicle or Above).
研究概览
简要总结
The purpose of this study is to determine if a new treatment is effective for the treatment of recurrent symptomatic oral herpes virus infections.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical history of recurrent cold sores averaging 2 or more episodes per year
- •Experiences prodromal symptoms (tingling, burning, itching) of cold sores
- •Herpes Simplex Virus seropositive (by blood test)
排除标准
- •Immuno-suppressed or taking immunosuppressant medication
- •Use of antiviral therapy directly prior and during the study
研究组 & 干预措施
BTL TML HSV
干预措施: BTL TML HSV (Drug)
Matching Placebo
干预措施: Matching placebo (Drug)
结局指标
主要结局
Proportion of Subjects Who Experience a New Cold Sore Outbreak That Proceeds to the Lesion Stage. Of Those Subjects That Take Study Medication (Experience a New Emerging Cold Sore) Those That Proceed to Lesion Stage (Cold Sore Stage - 3 Vesicle or Above).
时间窗: 7-14 days (depending on time of lesion outbreak - subjects had 7 days to experience a new emerging cold sore)
Subjects start a daily diary based on start of symptoms of a new emerging cold sore and start taking study medication. Subjects note the start time of study medication along with cold sore stage(s)for at least 7 days and up to 14 days. Subjects take study medication for 7 days. Cold Sore stages are 0=Dormant, 1=Prodrome, 2=Inflammation, 3=Vesicle, 4=Ulcer, 5=Crust, 6=Healed. If subjects do not experience a new cold sore outbreak within 7 days, they do not take study medication and are completed with the study.
次要结局
未报告次要终点