An Exploratory Study to Investigate the Inflammatory Response During a Cold Sore Episode
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Mean Change From Baseline in Blood Flow
研究概览
简要总结
This study will treat approximately 24 participants who experience cold sores. Patches will be applied to the cold sore for up to ten days, and the symptoms will be measured during daily clinic visits using non-invasive measurement techniques.
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
- 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
- 是
入选标准
- •Participants who are susceptible to cold sores that reactivate when exposed to ultraviolet (UV) light
排除标准
- 未提供
研究组 & 干预措施
Test patch
Patch containing acyclovir applied to cold sore
干预措施: Acyclovir patch (Device)
Placebo patch
Patch without acyclovir applied to cold sore
干预措施: Placebo patch (Device)
结局指标
主要结局
Mean Change From Baseline in Blood Flow
时间窗: Baseline to Day 10
Measurement of blood flow was performed using Field Laser Perfusion Imaging (FLPI) technique. Total episode value (TEV) was calculated as the summation of (test region response minus control region response) across all days. Maximum episode value (MEV) was calculated as the maximum of (test region response minus control region response) across all days.
Mean Change From Baseline in Temperature
时间窗: Baseline to Day 10
Lesion thermographic parameters for TEV and MEV were analysed.
Mean Change From Baseline in Color Intensity of Lesions
时间窗: Baseline to Day 10
The redness of the cold sores to be measured and quantified using sophisticated, standardized and reproducible color photography. Parameter represents distance between test and control values according to a\* axis and b\* axis colour intensity values. The values on the scale ranged from -100 (green, lowest intensity) to +100 (red, highest intensity).
次要结局
- Participant Assessment of Patch Comfort and Noticeability at Day 5(Day 5)
- Participant Assessment of Patch Comfort and Noticeability at Day 10(Day 10)
- Participant Assessment of Symptom Intensity at Day 5(Day 5)
- Participant Assessment of Symptom Intensity at Day 10(Day 10)