A study to determine the UVA Protection Factor of Test products in adult subjects.
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 UVA protection factor of the investigational
研究概览
简要总结
The test method is a laboratory method that utilizes a solar simulator of defined and known output to determine the protection provided by the sunscreen product on human skin.
On screening visit (within a week from the assessment day), the subjects will be enrolled into the study after obtaining their informed consent. Only subjects who qualify inclusion-exclusion criteria will be enrolled. As part of screening procedure, Spectrophotometer measurement will also be performed on the unexposed area and subject’s upper back (Test Area) to determine ITA° value (Individual Typology Angle) and their eligibility to participate in the study.
After determination of MPPDDU, the participants will be scheduled for the sunscreen test.
One of the randomized sites will be exposed to ultraviolet light (Total UV, calibrated with UV-Bio radiometer) without any protection, and the other randomized test sites will be exposed after the application of the test products and reference sunscreen formulation respectively. The following day, MPPDDU (Minimal Persistent pigment darkening dose - untreated site), MPPDDP (Minimal Persistent pigment darkening dose – study product site), MPPDDSTD (Minimal persistent pigment darkening dose – Standard) will be recorded 20 + 4 hours following the UV exposure.
The assessments must be performed at 20 + 4 hours post-exposure. The time between exposure and assessment must be similar for all test sites. These responses will be visually assessed* for the presence of persistent pigmentation (UVAPF), 20 + 4 hours after UV irradiation, by the investigator. Observations of protected (product) and unprotected test sites shall be conducted at the same relative time point after the end of the exposures (i.e. if at 4 h, it is 4 h after completion of exposures for the unprotected site and 4 h after completion of the protected site, not actually at the same time). Observations shall all be made on the same day.
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
- 18.00 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 18 – 55 years (both the ages inclusive).
- •Subjects with a colorimetric ITA value in the range of 20-41o, providing persistent pigmentation darkening to the UVA dose.
- •(Phototype of the subject will be recorded)
- •Subjects having a clear back with uniform colour and no sunburn (erythema), 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.
- •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.
- •Subject willing to avoid any exposure of the test area to artificial or natural Ultraviolet (UV) light throughout the course of the study.
- •Subjects willing to adhere to the study procedure, restrictions and visit the study site for follow up visits at the specified date and time.
- •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.
- •Subjects who have participated in a similar investigation in the past 8 weeks.
结局指标
主要结局
To evaluate the UVA protection factor of the investigational
时间窗: Approximately for 06 days for each subject.
product in adult subjects.
时间窗: Approximately for 06 days for each subject.
次要结局
未报告次要终点
研究者
Dr Mukta Sachdev
MS Clinical Research Pvt.Ltd