CTRI/2021/04/033206已完成不适用
Evaluation of Skin Safety of 3 test products for Primary Skin Irritation Using Skin Irritation Test (Patch Test in Humans)IS 4011:2018 Guidelines.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Evaluation of cutaneous tolerance by dermatological scoring of skin reactions using Draize scale
研究概览
简要总结
VISIT 1: Patch application
VISIT 2 (24 hrs): Patches was removed.
VISIT 3 (48 hrs): Clinical examination and scoring of test area using Draize scale.
VISIT 4 (1 week): If reactions are observed, participants will be called 1 week thereafter.
The Test Products were found to be "Non Irritant" based on IS 4011:2018, Methods of test for safety evaluation of Cosmetics- Third Revision.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Fitzpatrick skin type III to IV.
- •Having apparently healthy skin on test area.
- •Willingness to avoid intense UV exposure on test site (sun or artificial UV), during the course of the study.
排除标准
- •Pregnancy (by history) and lactating women.
- •Scars, excessive terminal hair or tattoo on the studied area.
- •Hypersensitivity, allergy antecedent (to any cosmetic product, raw material, hair dye).
结局指标
主要结局
Evaluation of cutaneous tolerance by dermatological scoring of skin reactions using Draize scale
时间窗: 48 hours
次要结局
未报告次要终点
研究者
研究点 (1)
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