NCT03474874已完成不适用
Human Repeated Insult Patch Test
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 68
- 试验地点
- 2
- 主要终点
- Erythema at the Patch Test Site is Evaluated for Each Participant
研究概览
简要总结
Repeated insult patch test on healthy males and females to determine potential contact irritation or contact allergy in the skin
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects must understand and execute an Informed Consent Form that includes a HIPAA statement;
- •Subjects must be considered dependable and able to follow directions
排除标准
- •Subjects who are in ill health;
- •Subjects who are taking medications other than birth control;
- •Female subjects who are pregnant (return positive urine pregnancy test), planning to become pregnant or lactating during the course of the trial;
- •Subjects who have a history of adverse reactions to personal care products, or known sensitivity to the test materials or their constituents including patch materials;
- •Subjects with any active skin disease;
- •Subjects who have heavy alcohol consumption;
- •Subjects with current use or history of repeated use of street drugs;
- •Subjects with a significant past medical history to potentially effect results of study;
- •Subjects with immunization less than 10 days prior to the test patch application;
研究组 & 干预措施
Collagen Dressing and Comparator
Other
NeoMatriX Collagen Dressing and Comparators - positive control and normal saline will be applied to the absorbent pad portion of the exclusive dressing.
干预措施: NeoMatriX Collagen Dressing (Device)
结局指标
主要结局
Erythema at the Patch Test Site is Evaluated for Each Participant
时间窗: 3 weeks
Erythema Scoring Scale with 0 being no visible erythema and 5 being bullous reaction.
次要结局
- Sensitization Reactions(5 weeks)
研究者
研究点 (2)
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