CTRI/2023/02/049856已完成不适用
A randomized study to determine the Sun Protection Factor of Test product in healthy adult participants
Unilever Industries Pvt Ltd1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2023年2月22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 of the investigational product in reference to standard product in healthy adult participants.
研究概览
简要总结
This is a single centre, double blinded, randomised and controlled study. The study will be conducted for a total of 4 visits for each participant at the study site. Once the subject is enrolled the test product will be applied on the back and then UV exposure will be performed. Post exposure , the assessment will be performed at 24 hrs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 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
- •Participant able to read, understand and sign on informed consent form indicating willingness to participate in the study.
- •Participants of either male or female gender in age group 18 – 55 years (both the ages inclusive).
- •Test participants 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 participants making up a test panel shall have an ITA° between 41° and 55°.
- •[When possible, there should be participants with ITA°s in each of the three ITA° bands, 28° to 40°, 41° to 55°, and >56°.
- •Where this is not possible, there shall be at least three individuals in each of 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
- •Participants willing to discontinue the use of soaps and cosmetic products (e.g. creams, moisturizers) in the treatment areas throughout the course of the study.
- •Participant willing to avoid any exposure of the test area to artificial or natural Ultraviolet (UV) light throughout the course of the study.
- •Participants willing to adhere and comply to the study protocol, procedure, restrictions and vising the study site for follow up visits at the specified date and time.
- •Participants with no known abnormal response to sunlight.
- •Participants willing and capable to follow the study rules and a fixed schedule.
排除标准
- •â€¢Participants showing COVID symptoms (cold, cough, fever, fatigue, headache, diarrhea, difficulty in breathing) •Participants who do not qualify on the thermal screening (body temperature higher than 37.5oC) or report to the study site without appropriate mask.
- •â€¢If any household member is positive (self-reported by the participants) within the 10 days prior to screening or during the study, then the participant will be withdrawn from the study.
- •â€¢Participants who disagree to follow the COVID safety protocol during the study.
- •â€¢Participants who have travelled outside the state (current interstate travel regulation) in the last 10 days and do not have negative RT-PCR report issued in last 72 hours
- •Participants with sun tan, blemishes, photo-toxicity reactions, cuts, abrasions, wounds, injuries, allergic reactions (in the tested area).
- •Participants allergic to cosmetic products such as moisturizers, creams and body lotion or anything else.
- •Skin allergy antecedents or atopic participants.
- •Participants having history of or having active photo dermatitis.
- •Participants on any known medication for photosensitization.
- •Participants with cutaneous disease which may influence the study result.
- •Participants on oral corticosteroid in last 2 months.
- •Participants participating in any other cosmetic or therapeutic study.
- •Participants who are pregnant or lactating
- •Participants who have participated in a similar investigation in the past 8 weeks.
- •Participants who are currently an employee of MSCR or Unilever.
结局指标
主要结局
To evaluate the sun protection factor of the investigational product in reference to standard product in healthy adult participants.
时间窗: 24 hours
次要结局
未报告次要终点
研究者
研究点 (1)
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