50 Human Subject Repeat Insult Patch Test Skin Irritation/Sensitization Evaluation (Occlusive Patch)
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
- Erythema
研究概览
简要总结
Consumer products or raw materials designed for consistent reapplication to areas of the skin may, under proper conditions, prove to be contact sensitizers or irritants in certain individuals. It is the intention of a Repeat Insult Patch Test (RIPT) to provide a basis for evaluation of this irritation/sensitization potential if such exists.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 67 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Individuals who are not currently under a doctor's care
- •Individuals free of any dermatological or systemic disorder which would interfere with the results, at the discretion of the Investigator.
- •Individuals free of any acute or chronic disease that might interfere with or increase the risk of study participation.
- •Individuals who will complete a preliminary medical history form mandated by AMA Laboratories, Inc. and are in general good health.
- •Individuals, who will read, understand and sign an informed consent document relating to the specific type of study they are subscribing. Consent forms are kept on file and are available for examination on the premises of AMA Laboratories, Inc. only.
- •Individuals able to cooperate with the Investigator and research staff, willing to have test materials applied according to the protocol, and complete the full course of the study.
排除标准
- •Individuals under 18 years of age.
- •Individuals who are currently under a doctor's care.
- •Individuals who are currently taking any medication (topical or systemic) that may mask or interfere with the test results.
- •Subjects with a history of any acute or chronic disease that might interfere with or increase the risk associated with study participation.
- •Individuals diagnosed with chronic skin allergies.
- •Female volunteers who indicate that they are pregnant or lactating.
研究组 & 干预措施
Test product
干预措施: CB-0002B (Other)
结局指标
主要结局
Erythema
时间窗: 21 days
Erythema rated on a numeric scale from 0 - 4. (0: None; 1: Minimal; 2: Mild; 3: Marked and 4: Severe erythema)
Sensitisation
时间窗: 48 hours
After a 10-14 day rest period, a challenge test was given at a different skin site to look for signals of a sensitization response measured by rating erythema on a scale from 0 - 4
Sensitisation
时间窗: 24 hours
After a 10-14 day rest period, a challenge test was given at a different skin site to look for signals of a sensitization response measured by rating erythema on a scale from 0 - 4
次要结局
未报告次要终点