CTRI/2024/11/076308已完成不适用
A study to determine the Sun Protection Factor and Water Resistance ability of Test Sunscreen products in adult subjects.
ITC Life Sciences & Technology Centre1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2024年11月8日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- To evaluate the sun protection factor and water resistance of test sunscreen products in adult subjects.
研究概览
简要总结
The study employs a solar simulator to assess the protective efficacy of sunscreen on human skin. Participants undergo screening to determine eligibility, including ITA° value measurement. A provisional MEDu is established to set UV exposure ranges for untreated and treated sites. During the sunscreen test, one site is exposed to UV without protection, while others receive test and reference products. Erythema is evaluated 20±4 hours post-exposure. Water resistance is assessed through controlled immersion cycles, followed by air drying, before additional UV exposure to measure SPFiwr, adhering to ISO guidelines.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 19.00 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 age group 19 – 55 years (both the ages inclusive).
- •Test subjects shall have an ITA value of at least 28 by colorimetric methods and be untanned on the test area (i.e., back)
- •The average of the subjects making up a test panel shall have an ITA between 41 and
- •[When possible, there should be subjects with ITAs in each of the three ITA bands, 28 to 40, 41 to 55, and more than
- •Where this is not possible, there shall be at least three individuals in at least two of the three ITA 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 greater than 5 from each other or the MEDu test area
- •Subjects willing to discontinue the use of soaps and cosmetic products (e.g. creams, moisturizers) in the treatment areas throughout the course of the study.
- •Subjects willing to undergo water immersion testing, ensuring that the upper body or test sites remain submerged during a simulated swim test device.
- •Subject willing to avoid any exposure of the test area to artificial or natural Ultraviolet (UV) light throughout the course of the study.
- •Subjects with no known abnormal response to sunlight.
排除标准
- •Subjects with sun tan, blemishes, photo-toxicity reactions, cuts, abrasions, wounds, injuries, allergic reactions (in the tested area).
- •Subjects allergic to cosmetic products 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.
- •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
- •Subjects with any history of underlying uncontrolled medical illness including diabetes, liver disease or history of alcoholism, HIV or any other serious medical illness.
- •People suffering from CVD or hypertension or hypotension or are prone to develop hypothermia and subjects suffering from arthritis (all conditions are self-declared).
- •Subjects who have participated in a similar investigation in the past 8 weeks.
结局指标
主要结局
To evaluate the sun protection factor and water resistance of test sunscreen products in adult subjects.
时间窗: Approximately 6 days for each subject
次要结局
- NA(NA)
研究者
Dr Mukta Sachdev
MS Clinical Research Pvt. Ltd
研究点 (1)
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