NCT01355653已完成不适用
AN OPEN LABEL STUDY TO COMPARE THE EFFECTS OF AGE AND BODY FAT ON THE SAFETY OF TWO HEAT WRAP DEVICES IN HEALTHY SUBJECTS
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Percentage of subjects with any thermal-related skin events (defined as elevated skin response, erythema ≥ 2.0 [moderate], or pain upon touch plus non-zero erythema)
研究概览
简要总结
This study is designed to compare the safety, as measured by skin findings and adverse events, of two different heat devices in elderly, overweight, and elderly and overweight subjects.
详细描述
Safety measurements
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 84 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males or females in generally good health, and who are either 18-54 years of age with a body mass index of ≥ 30 kg/m2
- •or 55-84 years of age and with a body mass index ≥ 30 kg/m2 or < 30 kg/m2
- •Females who are not pregnant or breastfeeding
- •Subject is medically cleared for study participation
排除标准
- •No sensitivitiy or allergy to device components in contact with skin
- •Any active skin disease or tattoos at the test site that would affect participation
结局指标
主要结局
Percentage of subjects with any thermal-related skin events (defined as elevated skin response, erythema ≥ 2.0 [moderate], or pain upon touch plus non-zero erythema)
时间窗: morning after product wear through 15 days after last product application
次要结局
- Percentage of subjects with any adverse event(during and after wear for 28 days after last wear)
研究者
研究点 (2)
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