Efficacy Evaluation of Products Against Long Wavelength Ultraviolet A1 and Visible Light Induced Biological Effects
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Change in Diffuse Reflectance Spectroscopy
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of topical products in providing protection against the visible light and ultraviolet A1 (UVA1) part of sunlight. Ultraviolet radiation and visible light are both components of sunlight that reach the earth. It is important to test these topical products against visible light and UVA1 because our current sunscreens may not protect against these very well.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient age 18 and older
- •Patients Fitzpatrick skin phototype (SPT) III-IV with normal skin health
- •Patient able to understand requirements of the study and risks involved
排除标准
- •A recent history of vitiligo, melasma, and other disorders of pigmentation with the exception of post inflammatory hyperpigmentation
- •A history of a relevant skin condition on any part of the patient's body (e.g. atopic dermatitis, eczema, vitiligo, sun burn, etc.
- •A known history of photodermatoses
- •A known history of photosensitivity disorders
- •A known history of melanoma or non-melanoma skin cancers
研究组 & 干预措施
Topical products and Untreated areas
The subject will serve as their own control. Four different products will be tested.
干预措施: Sunscreening Agents (Drug)
结局指标
主要结局
Change in Diffuse Reflectance Spectroscopy
时间窗: through study completion, an average of 1 week
Measures erythema and pigmentation
Change in Investigator's Global Assessment (IGA)
时间窗: through study completion, an average of 1 week
Assesses erythema and pigmentation
Change in Colorimetry
时间窗: through study completion, an average of 1 week
Measures erythema and pigmentation
次要结局
未报告次要终点
研究者
Iltefat Hamzavi
Senior Staff Physician, Director of Investigator-Initiated Trials
Henry Ford Health System