Human Repeat Insult Patch Test (HRIPT)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Evaluation of cutaneous tolerance by dermatological scoring
研究概览
简要总结
HRIPT was conductedfor 10 Products. The following products
· TheMoms Co. Natural Soothing Relief Lotion - Batch No.: R107290618
· TheMoms Co. Natural Soothing Relief Wash - Batch No.: R108290618
· TheMoms Co. Natural Baby Cream - BatchNo.: R109290618
· TheMoms Co. Natural Tummy Relief Oil - Batch No.: KR-MC-P38
· TheMoms Co. Natural Foaming Hand Wash - Batch No.: R11290618
· **TheMoms Co. Natural Water Wipes -**Batch No.: 8318
· TheMoms Co. Mineral Based Sunscreen - Batch No.: R106290618
· The Moms Co. Alcohol Free Hand Sanitizer - Batch No.: KR-MC-P39
were found to be Non-Irritant and likely to be hypoallergenic.
The following products
· TheMoms Co. Natural Mosquito Repellent - Batch No.: KR-MC-P47
· TheMoms Co. Natural Baby Bottom Wash - Batch No.: R110290618
were found to be Non-Irritant but likely to be allergenic.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Having apparently healthy skin on studied area.
- •For whom the Investigator considers that the compliance will be correct.
- •Willingness to avoid water contact or activity which cause sweating, during the course of the study.
排除标准
- •People who have a job involving water contact or a job which causes perspiration.
- •Pregnancy and lactating women.
- •Hypersensitivity allergy antecedent to any cosmetic product in general or raw material by history.
- •Participants with any skin condition that may cause interference with interpretation of the reactions or participants with past or present history of a photosensitive dermatosis.
结局指标
主要结局
Evaluation of cutaneous tolerance by dermatological scoring
时间窗: Induction Phase: Visit 3, Visit 5, Visit 7, Visit 9, Visit 11, Visit 13, Visit 15, Visit 17, Visit 19. | Challenge Phase: Visit 22, Visit 23 and Visit 24
次要结局
未报告次要终点