CTRI/2021/03/032171已完成不适用
Evaluation of Skin Safety of 1 test product (Luliconazole & Salicylic Acid & Zinc Pyrithione Shampoo) 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 skin irritation reactions using Draize scale
研究概览
简要总结
The test product,
• Luliconazole, Salicylic Acid & ZincPyrithione Shampoo - B No.: L20LZ001
was dermatologically tested and found to be“Non-Irritant†based on IS 4011:2018, Methods of Test for safety evaluation ofcosmetics - Third Revision.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- 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
- •Photo type III to V 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 skin irritation 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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