CTRI/2024/06/068883尚未招募2/3 期
A randomized study to evaluate the Sun Protection Factor and water resistance properties of a test product.
Transformative Learning Solution Pvt. Ltd.1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2024年6月17日最近更新:
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- 1.To evaluate the sun protection factor of the test product in reference to standard product in healthy adult subjects.
研究概览
简要总结
This study aims to assess the sun protection factor (SPF) and water resistance of a specific sunscreen product. By evaluating SPF efficacy and water immersion performance, of the product in comparison with standard reference.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- All
入选标准
- •Subject able to read, understand and sign on informed consent form indicating willingness to participate in the study.
- •Subjects of both genders in the age group of 18 to 55 years (both the ages inclusive).
- •Test subjects shall have an ITA degree value of at least 28 degree by colorimetric methods and be untanned on the test area that is back area.
- •The average of the subjects making up a test panel shall have an ITA degree between 41 and
- •[When possible, there should be subjects with ITA degrees in each of the three ITA degree bands, 28 degree to 40degree, 41degree to 55 degree, and more than 56°.
- •Where this is not possible, there shall be at least three individuals in each of two of the three ITA degree bands described in the previous sentence].
- •The test sites intended for UV exposure shall be free from blemishes and hair, and have an even colour tone with no variation in ITA degree greater than 5 degree from each other or the MEDu test area.
- •Subjects willing to undergo water immersion testing, ensuring that the upper body or test sites remain submerged during a simulated swim test device.
- •Subjects willing to discontinue the use of soaps and cosmetic product (e.g. creams, moisturizers) in the test areas throughout the course of the study.
- •Subject willing to avoid any exposure of the test area to artificial or natural Ultraviolet (UV) light throughout the course of the study.
- •Subjects willing to adhere to the study procedure, restrictions and visiting the study site for follow up visits at the specified date and time.
- •Subjects with no known abnormal response to sunlight.
- •Subjects willing and capable to follow the study rules and a fixed schedule.
排除标准
- •Subjects with suntan, blemishes, photo-toxicity reactions, cuts, abrasions, wounds, injuries, allergic reactions (in the test area).
- •Subjects allergic to cosmetic product such as moisturizers, creams and body lotion or anything else.
- •Skin allergy antecedents or atopic subjects.
- •Subjects having history of or having active photo dermatitis.
- •Subjects on any known medication for photosensitization.
- •(e.g. oral diabetic medications, Sulphur drugs, cancer chemotherapy)
- •Subjects with cutaneous disease which may influence the study result.
- •Subjects on oral corticosteroid in last 2 months.
- •Subjects participating in any other cosmetic or therapeutic study.
- •Subjects who are pregnant or lactating (self-declared)
- •Subjects with any history of underlying uncontrolled medical illness including diabetes, liver disease or history of alcoholism, HIV or any other serious medical illness.
- •Subjects who have participated in a similar investigation in the past 8 weeks.
- •Subjects who are currently an employee of MSCR or the sponsor.
结局指标
主要结局
1.To evaluate the sun protection factor of the test product in reference to standard product in healthy adult subjects.
2.To evaluate water resistance properties of the test product.
1.To evaluate the sun protection factor of the test product in reference to standard product in healthy adult subjects.
时间窗: N/A
2.To evaluate water resistance properties of the test product.
时间窗: N/A
次要结局
- N/A(N/A)
研究者
Dr Sukrutha S D
MS Clinical Research Pvt. Ltd
研究点 (1)
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