A Randomized, Double-Blind, Active Controlled, Vehicle-Controlled, Subject Initiated Study Comparing Efficacy and Safety of ME-609 Versus Acyclovir Cream for Treatment of Recurrent Herpes Simplex Labialis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,443
- 试验地点
- 1
- 主要终点
- Proportion of subjects with non-ulcerative recurrences measured as the proportion of subjects in whom the study recurrence did not progress beyond the papule stage.
研究概览
简要总结
The purpose of this study is to determine whether ME-609 is more efficient than acyclovir and placebo for the treatment of recurrent herpes labialis.
详细描述
This was a randomized, double-blind, active- and vehicle-controlled study comparing the effects of ME-609, acyclovir in ME-609 vehicle, and vehicle alone. Treatment was subject-initiated within 1 hour of experiencing the first signs or symptoms of a herpes recurrence. The subject visited a study clinic as soon as possible after treatment initiation, but no later than midnight of the following day, for evaluation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •Generally good health
- •History of recurrent herpes labialis with at last three episodes during the prior 12 months
排除标准
- •Treatment with antivirals or immunosuppressive agents within 2 weeks prior to randomization
- •Pregnant and/or nursing women
- •Continuous daily treatment with pain medication
- •Significant skin condition that occur in the area of herpes recurrences
研究组 & 干预措施
2
Acyclovir in ME-609 vehicle
干预措施: acyclovir in ME-609 vehicle (Drug)
1
ME-609
干预措施: ME-609 (Drug)
3
Vehicle
干预措施: Vehicle (Drug)
结局指标
主要结局
Proportion of subjects with non-ulcerative recurrences measured as the proportion of subjects in whom the study recurrence did not progress beyond the papule stage.
时间窗: 5 days
次要结局
- Episode duration(until healing)