A study to determine the Sun Protection Factor of Test product in Indian adult trial participants
试验速览
- 阶段
- 1/2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- the sun protection factor of the investigational products in reference to standard product in healthy adult trial participants.
研究概览
简要总结
This is a monocentric, randomized, double-blinded, controlled study designed to evaluate the sun protection efficacy (SPF) of a sunscreen product using a solar simulator. Eligible trial participants will provide informed consent and undergo screening, including ITA° value determination via spectrophotometry on the upper back. Based on the ITA°, a provisional MED (Minimal Erythema Dose – untreated) will be estimated using standardized UV dose increments. Test sites on the upper back will be marked and exposed to UV radiation with and without sunscreen products. Each test site includes six sub-sites, five of which receive UV exposure in 25% incremental doses, and one serves as a control. MEDu, MEDP, and MEDSTD values will be visually assessed 20 ± 4 hours post-exposure under controlled temperature conditions. The SPF will be determined based on erythema response at each site.
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
- •Trial participant able to read, understand and sign on informed consent form indicating willingness to participate in the study.
- •Trial participants of both genders in age group 18 – 55 years (both the ages inclusive).
- •Participants selected for the SPF test must have an Individual Typology Angle (ITA) value of at least 28 degrees as measured by colorimetric methods and should have untanned skin on the test area (i.e., back)
- •The average ITA value of participants in the test panel must fall between 41 and 55 degrees.
- •If possible, participants should be selected from all three ITA bands: 28 to 40 degrees, 41 to 55 degrees, and greater than 56 degrees.
- •If not feasible, there must be at least three participants from any two of these three bands
- •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
- •Trial 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.
- •Trial participant willing to avoid any exposure of the test area to artificial or natural Ultraviolet (UV) light throughout the course of the study.
- •Trial participants willing to adhere to the study procedure, restrictions and vising the study site for follow up visits at the specified date and time.
- •Trial participants willing and capable to follow the study rules and a fixed schedule.
- •Trial participant in Good physical and mental health with, in the opinion of the investigator or medically qualified person.
排除标准
- •Trial participants with sun tan, blemishes, photo-toxicity reactions, cuts, marks abrasions, wounds, injuries, allergic reactions (in the tested area).
- •Trial participants allergic to cosmetic products such as moisturizers, creams and body lotion or anything else.
- •Skin allergy antecedents or atopic trial participants.
- •Trial participants having history of or having active photo dermatitis.
- •Trial participants on any known medication for photosensitization.
- •oral diabetic medications, Sulphur drugs, cancer chemotherapy)
- •Trial participants with cutaneous disease which may influence the study result.
- •Trial participants on oral corticosteroid in last 2 months.
- •Trial participants using anti-inflammatory medication
- •Trial participants with systemic dermatological conditions (including dysplas-tic nevi);
- •Trial participants with a history of abnormal response to the sun
- •Trial participants presenting with existing sun damage in the test area
- •Trial participants participating in any other cosmetic or therapeutic study.
- •Trial participants who are pregnant or lactating (self-declared)
- •Trial participants with any history of underlying uncontrolled medical illness including diabetes, liver disease or history of alcoholism, HIV or any other serious medical illness.
- •Trial Participants who have used self-tanning products on the back area in the previous 1 month prior to screening.
结局指标
主要结局
the sun protection factor of the investigational products in reference to standard product in healthy adult trial participants.
时间窗: UV exposure Day | Assessment day (+24 hours) | UV exposure Day | Assessment day (+24 hours)
次要结局
未报告次要终点
研究者
Dr Mukta Sachdev
MS Clinical Research Pvt. Ltd