A study to determine the UVA and UVB Protection Factor of Test product in Indian adult trial participants.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- To evaluate the UVA 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 monocentric, randomized, double-blinded, and controlled study is designed to evaluate the UVA protection efficacy (UVAPF) of sunscreen products using a standardized laboratory method. A calibrated solar simulator will be used to assess the level of protection the sunscreen provides against UVA-induced pigmentation on human skin. During the screening visit, participants will provide written informed consent and will be assessed for eligibility based on inclusion and exclusion criteria. A spectrophotometer will be used to measure the ITA° (Individual Typology Angle) value on the upper back to confirm suitability for the study. The Minimal Persistent Pigment Darkening Dose (MPPDDU) will be determined by exposing the test site to a series of five incremental UVA doses, identifying the lowest dose that causes visible and persistent pigmentation 2 to 24 hours after exposure. Once the MPPDDU is established, participants will proceed to the sunscreen test. Randomized sites on the upper back will be exposed to UVA—one without protection and others after the application of the test product and standard sunscreen. Visual assessments will be conducted 20 ± 4 hours after exposure to evaluate pigment darkening at each site. The UVA protection factor (UVAPFi) will be calculated for each participant as the ratio of the MPPDD at the test product site (MPPDDP) to the MPPDD at the untreated site (MPPDDU), reflecting the level of UVA protection offered by the product.
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 the informed consent form indicating willingness to participate in the study
- •Trial participants of both genders in the age group 18 to 55 years inclusive
- •Trial participants with a colorimetric ITA value in the range of 18 to 43 degrees, providing persistent pigmentation darkening to the UVA dose.
- •Phototype of the trial participant will be recorded
- •Trial participants having a clear back with uniform color and no sunburn, tan, blemishes, cuts, wounds, injuries, allergies, or any skin condition on the test areas upper back region between scapula and waist that can hamper the assessment
- •Trial participants willing to discontinue the use of soaps and cosmetic products such as creams and moisturizers in the treatment areas throughout the course of the study
- •Trial participants 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 visiting the study site for follow-up visits at the specified date and time
- •Trial participants willing and capable of following the study rules and maintaining a fixed schedule
- •Trail 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, 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.
- •Trial participants using anti-inflammatory medication.
- •Trial participants with systemic dermatological conditions (including dysplastic nevi).
- •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 with a history of abnormal response to the sun or a history of skin cancer.
- •Trial participants participating in any other cosmetic or therapeutic study.
- •Trial participants presenting with existing sun damage in the test area.
- •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 participated in a similar investigation in the past 8 weeks.
- •Trial participants who are currently an employee of MSCR or the sponsor
- •Trial Participants who have used self-tanning/SPF products on the back area in the previous 2 month prior to screening.
结局指标
主要结局
To evaluate the UVA protection factor of the investigational products in reference to standard product in healthy adult trial participants.
时间窗: Day 1,Day 2,Day 3,Day 4,Day 5,Day 6
次要结局
未报告次要终点
研究者
Dr Mukta Sachdev
MS Clinical Research Pvt. Ltd