CTRI/2024/06/068883
尚未招募
2 期
A randomized study to evaluate the Sun Protection Factor and water resistance properties of a test product. - NI
Transformative Learning Solution Pvt. Ltd.0 个研究点目标入组 0 人待定
概览
- 阶段
- 2 期
- 干预措施
- 未指定
- 疾病 / 适应症
- 未指定
- 发起方
- Transformative Learning Solution Pvt. Ltd.
- 状态
- 尚未招募
- 最后更新
- 去年
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- •1\.Subject able to read, understand and sign on informed consent form indicating willingness to participate in the study.
- •2\.Subjects of both genders in the age group of 18 to 55 years (both the ages inclusive).
- •3\.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.
- •4\.The average of the subjects making up a test panel shall have an ITA degree between 41 and 55\. \[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].
- •5\.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.
- •6\.Subjects willing to undergo water immersion testing, ensuring that the upper body or test sites remain submerged during a simulated swim test device.
- •7\.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.
- •8\.Subject willing to avoid any exposure of the test area to artificial or natural Ultraviolet (UV) light throughout the course of the study.
- •9\.Subjects willing to adhere to the study procedure, restrictions and visiting the study site for follow up visits at the specified date and time.
- •10\.Subjects with no known abnormal response to sunlight.
排除标准
- •Subjects with suntan, blemishes, photo\-toxicity reactions, cuts, abrasions, wounds, injuries, allergic reactions (in the test area).
- •2\.Subjects allergic to cosmetic product such as moisturizers, creams and body lotion or anything else.
- •3\.Skin allergy antecedents or atopic subjects.
- •4\.Subjects having history of or having active photo dermatitis.
- •5\.Subjects on any known medication for photosensitization. (e.g. oral diabetic
- •medications, Sulphur drugs, cancer chemotherapy)
- •6\.Subjects with cutaneous disease which may influence the study result.
- •7\.Subjects on oral corticosteroid in last 2 months.
- •8\.Subjects participating in any other cosmetic or therapeutic study.
- •9\.Subjects who are pregnant or lactating (self\-declared)
结局指标
主要结局
未指定
相似试验
尚未招募
不适用
In this study the Sun Protection Factor of SPF will be determined.CTRI/2019/01/017283Sami Labs Limited
已完成
不适用
A study to check the sun protection benefitsCTRI/2023/02/049856nilever Industries Pvt Ltd10
已完成
2 期
A study to determine the protection factor of a test product against sun rays.CTRI/2021/04/032696ITC Life Sciences Technology Centre20
尚未招募
4 期
To asses Sun Protection Factor of N G Sunscreen Sample- FND29768CTRI/2024/04/066576G Electro Product Pvt Ltd
招募中
4 期
Determine the sun protection factor of the Dry touch Sunscreen gelCTRI/2023/10/058989G Electro Product Private Limited