NCT00375570已完成3 期
An Open Label, Multi-Centre, Phase III, Subject Initiated Safety Study of ME-609 in Treatment of Recurrent Herpes Simplex Labialis in Adolescents
Medivir0 个研究点目标入组 254 人开始时间: 2006年10月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 254
- 主要终点
- Adverse Event
研究概览
简要总结
The Purpose of this study is to evaluate the safety of ME-609 for the treatment of recurrent herpes labialis in adolescents.
详细描述
The objective of the study was to evaluate the safety of ME-609 for the treatment of herpes labialis recurrences in immunocompetent adolescents, 12 - 17 years of age, following a 5-day treatment with 5-time daily topical administration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •General good health
- •History of recurrent herpes labialis with at two recurrences during the last twelve months
排除标准
- •Treatment with systemic or topical antiviral agents or steroids within two weeks prior to inclusion
- •Significant skin condition that occur in the area of herpes recurrences
- •Nursing or/and pregnancy
- •Immunosupressed state due to underlying disease (e.g. HIV infection or concomitant treatment (e.g. cancer chemotherapy)
研究组 & 干预措施
1
Experimental
ME-609
干预措施: ME-609 (Drug)
结局指标
主要结局
Adverse Event
时间窗: 3 weeks after last dose
次要结局
未报告次要终点
研究者
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