The Effect of Topical Sunscreen Plus Antioxidant Against the Visible Light Biological Effects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- diffuse reflectance spectroscopy
研究概览
简要总结
Visible light is known to induce pigmentation in darker skin types. The investigators aim to study the effects of visible light on the skin after topical application of sunscreen plus antioxidant.
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 IV-VI
- •Patient able to understand requirements of the study and risks involved
- •Patient able to sign a consent form
排除标准
- •A recent history of vitiligo, melasma, and other disorders of pigmentation with the exception of post inflammatory hyperpigmentation
- •A known history of photodermatoses
- •A known history of melanoma or non-melanoma skin cancers
- •Those planning on going to the tanning parlors
- •Using any of the photosensitizing medication within the visible light range or additional medications at the discretion of the investigator (examples include (but not limited to) thiazide diuretics, regular use of NSAIDs, hydroxychloroquine, or voriconazole)
- •A woman who is lactating, pregnant, or planning to become pregnant
- •Patient planning on exposing the irradiated or control areas to the sun
- •known allergy to anesthetics (lidocaine or epinephrine)
结局指标
主要结局
diffuse reflectance spectroscopy
时间窗: Baseline- immediately after irradiation to assess immediate pigment darkening
Diffuse reflectance spectroscopy is a non-invasive objective measure of pigmentation based on reflectance patterns of the irradiated skin
investigator's global assessment score
时间窗: Baseline- Immediately after irradiation to assess immediate pigment darkening
The investigator's global assessment score is a non-invasive subjective measure of pigmentation in which investigators assign a value ranging between 0, corresponding with no hyperpigmentation, to 5, or severe or dark hyperpigmentation.
photography
时间窗: 24 hours after irradiation to assess persistent pigment darkening
Cross polarized photography is used to document pigmentation non-invasively and reduce surface glare of the skin.
Diffuse reflectance spectroscopy
时间窗: 7 days after irradiation to assess delayed tanning
Diffuse reflectance spectroscopy is a non-invasive objective measure of pigmentation based on reflectance patterns of the irradiated skin
Investigator's global assessment score
时间窗: 24 hours after irradiation to assess persistent pigment darkening
The investigator's global assessment score is a non-invasive subjective measure of pigmentation in which investigators assign a value ranging between 0, corresponding with no hyperpigmentation, to 5, or severe or dark hyperpigmentation.
Photography
时间窗: 7 days after irradiation to assess delayed tanning
Cross polarized photography is used to document pigmentation non-invasively and reduce surface glare of the skin.
Biological effects
时间窗: 24 hours after irradiation
biopsy with melanocyte and melanin stains to assess pigmentation
Investigator global assessment score
时间窗: 7 days after irradiation to assess delayed tanning
The investigator's global assessment score is a non-invasive subjective measure of pigmentation in which investigators assign a value ranging between 0, corresponding with no hyperpigmentation, to 5, or severe or dark hyperpigmentation.
次要结局
未报告次要终点
研究者
Iltefat Hamzavi
Principal Investigator
Henry Ford Health System