A Randomised, Double-blind, Vehicle Controlled, Single Center, Parallel Group, Comparative Study of the Efficacy of Penciclovir 10mg/g (1%) Cream in Preventing the Appearance of Classical Lesion in Recurrent Cold Sore Sufferers
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 126
- 试验地点
- 1
- 主要终点
- Clinical Assessment Performed by the Investigator and Skin Temperature at the Cold Sore.
研究概览
简要总结
Comparison of the efficacy of penciclovir 10 mg/g (1%) cream with that of vehicle at 72 hours in preventing the appearance of classical lesions following prodromal symptoms (tingling or burning sensation) based on thermographic assessment among recurrent cold sore sufferers.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be known to be a cold sore sufferer and presenting a prodromal stage with pain
- •Sign the written informed consent form prior to enrolment in the trial;
- •Be aged 18 to 75 years;
排除标准
- •If female, are pregnant, planning pregnancy or lactating;
- •Have a known hypersensitivity to penciclovir or any ingredients of the vehicle;
- •Have already ongoing classical cold sore lesions at the baseline visit;
- •Have taken any cold sore product, analgesic or NSAID in the 24 hours before the baseline visit;
- •Have applied a cosmetic lip balm on their lips in the 12 hours before the baseline thermographic assessment;
- •Are known to be immunosuppressed (acquired, congenital or therapeutic);
- •Have been involved in any investigational protocol within the 30 days prior to the trial;
- •Have evidence or history of drug or alcohol abuse;
研究组 & 干预措施
Penciclovir
Penciclovir
干预措施: Penciclovir (Drug)
Placebo
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Clinical Assessment Performed by the Investigator and Skin Temperature at the Cold Sore.
时间窗: 72 hours
Number of participants where the classical cold sore lesion was prevented at 72 hours after first treatment application.Lesion defined as having been prevented if clinical assessment is prodrome, macule or healed and skin temperature of the cold sore is negative (temperature difference of less than 0.5°C between initial site of cold sore and opposite side).
次要结局
- Size of the Cold Sore(72 hours)