Repeat Insult Patch Testing (RIPT) APPENDIX I to HRL Standard Protocol #100
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 121
- 试验地点
- 1
- 主要终点
- Number of Participants That Did Not Have Test Material Induced Clinically Significant Dermal Irritation
研究概览
简要总结
Patch Testing for device cream on human subjects
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or Female
- •18+ years
- •Good health
- •Signed and datad Informed Consent
- •Signed and dated HIPAA
排除标准
- •On test at any other research lab or clinic
- •Known allergy or sensitivity to cosmetics or toiletries
- •Pre-existing other medical conditions
- •Treatment with antibiotics, antihistamines, or corticosteroids within 2 weeks of the test
- •Chronic medication which could affect the outcome of the study
- •Known pregnant or nursing women
- •Cancer diagnosis within the past 5 years
研究组 & 干预措施
Test Panel
Light Therapy Mask Cream
干预措施: Light Therapy Mask Cream (Device)
结局指标
主要结局
Number of Participants That Did Not Have Test Material Induced Clinically Significant Dermal Irritation
时间窗: approximately 6 weeks
"Clinically Significant Dermal Irritation" refers to an overall outcome measure in which, after 6 weeks of the test (patching the skin (3 weeks) \& then challenging the skin (at week 6)), the test product caused a clinically significant dermal reaction (scores of 2 or greater). Participant scores less than 2 are not considered to be Clinically significant. Scoring System: 0 = No visible reaction ± = Faint, minimal erythema 1. = Erythema 2. = Intense erythema 3. = Intense erythema, induration, vesicles 4. = Severe reaction with erythema, induration, vesicles, pustules (may be weeping) E = Edema DR = Dryness P = Peeling S = Staining * = Hyperpigmentation / Hypopigmentation C = Change of test site N9R = No 9th reading * = No patch application and / or reading TR = Tape Reaction
次要结局
未报告次要终点