CTRI/2025/10/095750尚未招募不适用
An In Vivo Study to Determine the Sun Protection Factor (SPF) of Body Lotion.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Change in Individual Minimal Erythema Dose (iMED) Score
研究概览
简要总结
This is an in-vivo study designed to determine the Sun Protection Factor (SPF) of a topical formulation through a single assessment.
Potential participants will be screened based on inclusion and exclusion criteria, following the provision of written informed consent.
All eligible participants will undergo clinical evaluation by a Dermatologist following exposure to a solar simulator. Safety will be assessed throughout the study by monitoring adverse events (AEs).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Healthy adult males and non-pregnant/non-lactating females.
- •Participants with ITA° value of at least 28° using Chromameter and be untanned on the test area.
- •Participants with uniform skin color over the whole test area and with no variation in ITA° greater than 5° from each other or the MEDu test area.
- •Participants with test sites, free from pigmentation, nevi, sunburn and hair.
排除标准
- •Participants with a history of abnormal responses to the sun (e.g., phototoxic or photoallergic responses).
- •Participants having marks, blemishes or nevi in the test area.
- •Participants who had sun exposure on their back within the eight weeks leading up to the SPF testing.
- •Participants having skeletal protrusions and extreme areas of curvature in the test area.
结局指标
主要结局
Change in Individual Minimal Erythema Dose (iMED) Score
时间窗: Day 1
次要结局
- Delayed Erythema Response(Day 2)
研究者
Dr Parth Joshi
Cliantha Research
研究点 (1)
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