A Study to Evaluate the Cooling Sensation and Consumer Liking of a Skin Disinfectant Spray
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Participant-perceived Cooling Sensation at 5 Min
研究概览
简要总结
The objective of this randomised, examiner and subject blinded study is to evaluate and compare cooling performance and overall consumer liking of the prototype formulation with the currently marketed wound spray and negative control in subjects with experimental wounds. For each subject, three superficial wounds will be induced on two volar forearms, by sequential tape strippings until a glistening layer is visualized. After wounding, a randomised test product will be sprayed twice on test site, and the subject will be asked to complete a questionnaire evaluating product cooling performance and overall liking.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants in good health with healthy and intact skin on the test area
- •Age 18-60 years
排除标准
- •Pregnancy or breast-feeding
- •Allergy/Intolerance
- •Participants currently taking any topical or systemic treatments that may interfere with or mask the test results
- •Participants who have taken any topical anti-inflammation treatment in the application area in past 2 months
- •Participants who are vulnerable to any intervention
- •Damaged skin close to test site, active skin disorders, any visible skin disorder
结局指标
主要结局
Participant-perceived Cooling Sensation at 5 Min
时间窗: At 5 min after product application
The cooling sensation was assessed on VAS (0-100 mm, where 0= no cooling and 100= extreme cooling) at 5 min post study product application.
Participant-perceived Cooling Sensation at 15 Min
时间窗: At 15 min after product application
The cooling sensation was assessed on VAS (0-100 mm, where 0= no cooling and 100= extreme cooling) at 15 min post study product application.
Participant-perceived Cooling Sensation Immediately Post Product Application
时间窗: Immediately after product application
The cooling sensation was assessed immediately after the study product application on 100 millimeter (mm) Visual Analogue Scale (VAS) (0-100 mm, where 0= no cooling and 100= extreme cooling).
Participant-perceived Cooling Sensation at 3 Min
时间窗: At 3 min after product application
The cooling sensation was assessed on VAS (0-100 mm, where 0= no cooling and 100= extreme cooling) at 3 min post study product application.
次要结局
- Overall Sensory Liking of Study Products(Immediatey, 3 min, 5 min and 15 min after product application)