Evaluation of Cold Sore Treatments on UV Induced Cold Sores
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 303
- 试验地点
- 2
- 主要终点
- Number of Participants for Whom a Recurrent Oral Herpes Episode Initiated With Prodromal Symptoms Were Aborted Before Progressing to a Lesion as Assessed by a Trained Evaluator
研究概览
简要总结
The purpose of this study is to determine if a new drug treatment is effective to block the development of a cold sore lesion following Ultra Violet (UV) exposure.
详细描述
This was a multi-center, randomized, evaluator and subject-blind, placebo controlled study design
The objective of this study was to evaluate the ability of the test articles to block the development of a cold sore lesion from progressing beyond the prodromal stage following a UV-induced process.
The primary efficacy endpoint of this study was to determine if a recurrent oral herpes episode initiated with prodromal symptoms was aborted before progressing to a lesion (vesicle) via assessing lesion stages by a trained evaluator.
The secondary efficacy endpoints included: a) subject self-assessments and b) test article weights and diaries to track treatment compliance.
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, Investigator, Outcomes Assessor)
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
- •Clinical history of recurrent cold sores averaging 2 or more episodes per year
- •UV exposure is known to cause a cold sore outbreak
排除标准
- •History of abnormal reactions to sunlight
- •Used antiviral therapy directly prior to entering study
- •Any other condition which in the opinion of the Investigator may affect the results or place the subject at undue risk.
研究组 & 干预措施
Matching Placebo
Matching Placebo
干预措施: Matching Placebo (Drug)
BTL-TML-HSV
Experimental Product
干预措施: BTL-TML-HSV (Drug)
结局指标
主要结局
Number of Participants for Whom a Recurrent Oral Herpes Episode Initiated With Prodromal Symptoms Were Aborted Before Progressing to a Lesion as Assessed by a Trained Evaluator
时间窗: Day 0- Day 7
The primary efficacy endpoint of this study is to determine if a recurrent oral herpes episode initiated with prodromal symptoms is aborted before progressing to a lesion (vesicle stage) via assessing lesion stages by the trained evaluator. Any episode of oral herpes that did not reach a vesicle stage or higher by Day 7 (based on evaluator and self-assessments of legion stage) was considered "aborted" or "blocked". Any episode of oral herpes that reached a vesicle stage or higher by Day 7 was considered a treatment failure.
次要结局
- Number of Participants for Whom a Recurrent Oral Herpes Episode Initiated With Prodromal Symptoms Were Aborted Before Progressing to a Lesion as Assessed by the Participant(0 -7 days)