The Effect of Topical Sunscreen Plus Antioxidant Against the Visible Light Biological Effects
2022年2月15日 更新者：Iltefat Hamzavi、Henry Ford Health System
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.
研究概览
研究类型
介入性
注册 (实际的)
32
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
Michigan
-
Detroit、Michigan、美国、48202
- Henry Ford Hospital
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Sunscreen application
All subjects will undergo topical application of 3 products and an additional site will serve as a control
|
topical application sunscreen containing topical antioxidants and sunscreen filters
topical application of product A without topical antioxidants
Topical application of antioxidants only
No product applied
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
diffuse reflectance spectroscopy
大体时间：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
|
Baseline- immediately after irradiation to assess immediate pigment darkening
|
|
photography
大体时间：Baseline-immediately after irradiation to assess immediate pigment darkening
|
Cross polarized photography is used to document pigmentation non-invasively and reduce surface glare of the skin.
|
Baseline-immediately after irradiation to assess immediate pigment darkening
|
|
investigator's global assessment score
大体时间：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.
|
Baseline- Immediately after irradiation to assess immediate pigment darkening
|
|
Diffuse reflectance spectroscopy
大体时间：24 hours after irradiation to assess persistent pigment darkening
|
Diffuse reflectance spectroscopy is a non-invasive objective measure of pigmentation based on reflectance patterns of the irradiated skin
|
24 hours after irradiation to assess persistent pigment darkening
|
|
photography
大体时间：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.
|
24 hours after irradiation to assess persistent pigment darkening
|
|
Investigator's global assessment score
大体时间：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.
|
24 hours after irradiation to assess persistent pigment darkening
|
|
Diffuse reflectance spectroscopy
大体时间：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
|
7 days after irradiation to assess delayed tanning
|
|
Photography
大体时间：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.
|
7 days after irradiation to assess delayed tanning
|
|
Investigator global assessment score
大体时间：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.
|
7 days after irradiation to assess delayed tanning
|
|
Biological effects
大体时间：24 hours after irradiation
|
biopsy with melanocyte and melanin stains to assess pigmentation
|
24 hours after irradiation
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Mahmoud BH, Ruvolo E, Hexsel CL, Liu Y, Owen MR, Kollias N, Lim HW, Hamzavi IH. Impact of long-wavelength UVA and visible light on melanocompetent skin. J Invest Dermatol. 2010 Aug;130(8):2092-7. doi: 10.1038/jid.2010.95. Epub 2010 Apr 22.
- Porges SB, Kaidbey KH, Grove GL. Quantification of visible light-induced melanogenesis in human skin. Photodermatol. 1988 Oct;5(5):197-200.
- Mahmoud BH, Hexsel CL, Hamzavi IH, Lim HW. Effects of visible light on the skin. Photochem Photobiol. 2008 Mar-Apr;84(2):450-62. doi: 10.1111/j.1751-1097.2007.00286.x. Epub 2008 Jan 29.
- Kollias N, Baqer A. An experimental study of the changes in pigmentation in human skin in vivo with visible and near infrared light. Photochem Photobiol. 1984 May;39(5):651-9. doi: 10.1111/j.1751-1097.1984.tb03905.x. No abstract available.
- Duteil L, Cardot-Leccia N, Queille-Roussel C, Maubert Y, Harmelin Y, Boukari F, Ambrosetti D, Lacour JP, Passeron T. Differences in visible light-induced pigmentation according to wavelengths: a clinical and histological study in comparison with UVB exposure. Pigment Cell Melanoma Res. 2014 Sep;27(5):822-6. doi: 10.1111/pcmr.12273. Epub 2014 Jul 25.
- Yakes FM, Van Houten B. Mitochondrial DNA damage is more extensive and persists longer than nuclear DNA damage in human cells following oxidative stress. Proc Natl Acad Sci U S A. 1997 Jan 21;94(2):514-9. doi: 10.1073/pnas.94.2.514.
- Boukari F, Jourdan E, Fontas E, Montaudie H, Castela E, Lacour JP, Passeron T. Prevention of melasma relapses with sunscreen combining protection against UV and short wavelengths of visible light: a prospective randomized comparative trial. J Am Acad Dermatol. 2015 Jan;72(1):189-90.e1. doi: 10.1016/j.jaad.2014.08.023. Epub 2014 Oct 22. No abstract available.
- Wang SQ, Osterwalder U, Jung K. Ex vivo evaluation of radical sun protection factor in popular sunscreens with antioxidants. J Am Acad Dermatol. 2011 Sep;65(3):525-530. doi: 10.1016/j.jaad.2010.07.009. Epub 2011 May 31.
- Kunisada M, Sakumi K, Tominaga Y, Budiyanto A, Ueda M, Ichihashi M, Nakabeppu Y, Nishigori C. 8-Oxoguanine formation induced by chronic UVB exposure makes Ogg1 knockout mice susceptible to skin carcinogenesis. Cancer Res. 2005 Jul 15;65(14):6006-10. doi: 10.1158/0008-5472.CAN-05-0724.
- Herrling T, Jung K, Fuchs J. Measurements of UV-generated free radicals/reactive oxygen species (ROS) in skin. Spectrochim Acta A Mol Biomol Spectrosc. 2006 Mar 13;63(4):840-5. doi: 10.1016/j.saa.2005.10.013.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2018年3月13日
初级完成 (实际的)
2018年9月15日
研究完成 (实际的)
2019年4月22日
研究注册日期
首次提交
2017年1月30日
首先提交符合 QC 标准的
2017年2月22日
首次发布 (实际的)
2017年2月28日
研究记录更新
最后更新发布 (实际的)
2022年3月2日
上次提交的符合 QC 标准的更新
2022年2月15日
最后验证
2022年2月1日
更多信息
与本研究相关的术语
其他研究编号
- IRB # 9695
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
IPD 计划说明
No individual participant data will be available to other researchers.
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
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