CTRI/2025/04/084328尚未招募不适用
An In- Vivo Study to determine the Sun Protection factor of WeDerm Aqualogica Bright plus Tone up Sunscreen (AS5B038)on healthy human volunteers
We Derm Pvt Ltd1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2025年4月15日最近更新:
试验速览
- 阶段
- 不适用
- 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
This is the Invivo SPF test done as per ISO 24444 to determine the Sun Protection Factor
Test Product:
- Bright plus Tone up Sunscreen (AS5B038)
Done on 10 human volunteers. Duration: 3 Days
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Individual should have ITA angle in the range of 18 t0 40, 41 to 55, and greater than 56
- •Individuals free of any dermatological or systemic disorder which would interfere with the results, at the discretion of the investigator.
- •Individuals who have completed a preliminary medical history evaluation.
- •Individuals who have read, understood and signed an informed consent document relating to the specific study to which they are subscribing.
- •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: Day1, Day2
次要结局
- Not Applicable(Not Applicable)
研究者
研究点 (1)
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