CTRI/2024/04/066480尚未招募Unknown
An in-Vivo Study to Determine the Sun Protection Factor of NG Sunscreen 001ADEÂ
NG Electro Product Pvt Ltd1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2024年5月10日最近更新:
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Change in Individual MED (iMED) score
研究概览
简要总结
The below products would be tested as per the guidelineInternational Standard ISO 24444 and ISO 16217Product Name Sunscreen 001ADE
The study would be to estimate the SPF- sun protection factor
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Age 18-70 years.
- •2.Individual should have ITA angle in the range of 28-40, 41-55 and more than
- •3.Individuals free of any dermatological or systemic disorder which would interfere with the results, at the discretion of the investigator.
- •4.Individuals who have completed a preliminary medical history evaluation.
- •5.Individuals who have read, understood and signed an informed consent document relating to the specific study to which they are subscribing.
- •6.Individuals with no known abnormal response to sunlight.
排除标准
- •1.Individuals taking medication which in the opinion of the investigator would mask or interfere with the results.
- •2.Individuals with chronic skin allergies.
- •3.Individuals with suntan or sunburn.
- •4.Individuals with abnormal reaction to the sun.
- •5.Pregnant or lactating females.
- •6.Subjects accustomed to using sun beds.
- •7.Subjects who have participated in an SPF study within the last two months.
结局指标
主要结局
Change in Individual MED (iMED) score
时间窗: Day 1 and Day 2
次要结局
- Change in the redness of skin(Delayed Erythema Response)
研究者
Dr Robin Chugh
CCFT Laboratories
研究点 (1)
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