NCT00453401已完成2 期
The Safety, Pharmacokinetics, and Efficacy of NB-001 (0.1%, 0.3%, 0.5%) in Subjects With Recurrent Herpes Labialis
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 1,000
- 试验地点
- 56
- 主要终点
- Time to healing as assessed by the subject.
研究概览
简要总结
Purpose of this study is to determine the safety and efficacy of topical applications of NB-001 as compared to placebo for the treatment of recurrent herpes labialis.
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
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18 to 80 years of age of either gender
- •Good general health
- •History of recurrent herpes labialis with at least 3 episodes per year
排除标准
- •Pregnant and/or nursing female
- •Lesions or irritation on or around the lips that would interfere with recognition of a herpes labialis attack
- •Treatment with topical steroids, antivirals, or new topical products on or around the lips in the week prior to the onset of an attack
- •Known allergies to topical creams, ointments or medications.
- •Other protocol-defined inclusion/exclusion criteria may apply
结局指标
主要结局
Time to healing as assessed by the subject.
次要结局
- Percent of subjects with healing by days 3, 4,and 5 as assessed by the subject.
研究者
研究点 (56)
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