NCT01257074已完成3 期
A Randomized, Double-Blind, to Compare Non-inferiority Efficacy and Safety of Penciclovir 10mg/g to Acyclovir 50mg/g in the Treatment of Recurrent Herpes Labialis.
EMS1 个研究点 分布在 1 个国家目标入组 76 人开始时间: 2012年2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
- 76
- 试验地点
- 1
- 主要终点
- Efficacy will be evaluated by the proportion of subjects with non herpes labialis manifestation
研究概览
简要总结
Herpes labialis is the most common recurrent manifestation of herpes simplex. The purpose of this study is to check the non-inferiority efficacy and safety of penciclovir 10mg/g as treatment for Herpes Labialis in comparison to acyclovir 50mg/g.
详细描述
Study design:
• Double blinded non-inferiority prospective parallel-group, intend to treat trial.
Study design:
- Experiment duration: 10 days
- 3 visits (days 1,5 and 10)
- Erythema, papule, vesicle, ulcer, crust and healed skin evaluation
- Adverse events evaluation
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
- Triple (Participant, Care Provider, 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
- •Patients must be able to understand the study procedures agree to participate and give written consent.
- •Patients with clinical diagnosis of recurrent herpes labialis and are in the prodromal period (stinging, itching, burning and erythema) at the onset of signs / symptoms in the last 12-24 hours;
- •No history of reaction to topical products;
排除标准
- •Pregnancy or risk of pregnancy.
- •Use of anti-inflammatory or immunosuppressive drugs (last 30 days prior to the study.)
- •Sunlight over exposure in the last 15 days.
- •Any pathology or past medical condition that can interfere with this protocol.
- •AINH use, hormonal anti-inflammatory, analgesic and immunosuppressive drugs (in the last 30 days and during the study);
- •Patients with immunodeficiency and/or immunosuppressive disease;
- •Sunlight exposure in the last 15 days;
- •Hypersensitivity to components of the formula;
- •Other conditions deemed reasonable by the medical investigator as to the disqualification of the individual from study participation.
研究组 & 干预措施
Drug 1
Experimental
Penciclovir 10mg/g
干预措施: Penciclovir 10mg/g (Drug)
Drug 2
Active Comparator
Acyclovir 50mg/g
干预措施: Acyclovir 50mg/g (Drug)
结局指标
主要结局
Efficacy will be evaluated by the proportion of subjects with non herpes labialis manifestation
时间窗: Day 10
Symptoms evaluated: erythema, papule, vesicle, ulcer, crust, or healed skin.
次要结局
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability(Day 10)
研究者
研究点 (1)
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