CTRI/2021/04/033202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.
Lupin Ltd1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2021年3月5日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 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
The test products,
- AB NEXT Gel - B No.:AB20003
- Epiduo Gel - B No.: GU26
- Deriva BPO Gel - B No.: 10200454
were dermatologically tested and found to be “Non-Irritant†based on IS 4011:2018Methods of Test for safety evaluation of cosmetics - Third Revision.
Basedon a* values,
Erythemadeveloped due to AB NEXT Gel was significantly lower as compared to erythema developeddue to Epiduo Gel and Deriva BPO Gel.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 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
Evaluation of erythema using spectrophotometer (a value)
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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