The Effects of Visible Light on the Skin After Administration of Oral Polypodium Leucotomos
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Difference in pigmentation pre and post administration of oral PLE
研究概览
简要总结
Polypodium Leucotomos Extract (PLE) is a tropical fern that has antioxidative, photoprotective, chemoprotective, anti-inflammatory, and immunomodulatory properties. The antioxidative effects of PL include inhibition and scavenging of free radicals, lipid peroxidation and reactive oxygen species (ROS) such hydrogen peroxide, superoxide anion, hydroxyl radical and singlet oxygen. Visible light (400-700 nm) causes pigmentation in melanocompetent individuals and induces DNA damage in the human skin through ROS production. The goal of this study is to determine whether the administration of oral PLE has an effect on the development of visible light induced pigmentation.
详细描述
Polypodium Leucotomos (PL), a tropical fern that is grown in Central America, has been found to contain active compounds that provide antioxidative, photoprotective, chemoprotective, anti-inflammatory, and immunomodulatory properties.The antioxidative effects of PL include inhibition and scavenging of free radicals, lipid peroxidation and reactive oxygen species (ROS) such hydrogen peroxide, superoxide anion, hydroxyl radical and singlet oxygen.Ultraviolet radiation (UVR) and visible light (400-700 nm) can induce DNA damage in the human skin through ROS production.
The visible spectrum is the part of the electromagnetic radiation that is visible to the human eye. While many of the photodermatology studies have focused mainly on the UV portion of the electromagnetic radiation spectrum, as of lately, there have been more studies on visible light. The visible light radiation can exert various biologic effects such as erythema, pigmentation, thermal damage and free radical production. Addtionally, visible light exposure can cause or exacerbate photodermatoses such as solar urticaria, chronic actinic dermatosis (CAD) and cutaneous porphyrias. Sunscreens are the mainstay treatment for these photodermatoses, but often sunscreens offer none to weak protection against visible light.
In the past, studies have studied the erythema development and pigmentary changes induced by visible light. A recent study by Mahmoud et al. reported that visible light induces dark and relatively sustained pigmentation, which has clinical relevance in the treatment of photodermatoses as well as the need for development of filters that protect against visible light.
PURPOSE: To study the effects of visible light on the skin after administration of oral Polypodium leucotomos.
SPECIFIC AIMS:
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 100 Years（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 III-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 photosensitivity disorders
- •A known history of melanoma or non-melanoma skin cancers
- •Those planning on going to the tanning parlors
- •Using any of the photosensitizing medication
- •A woman who is lactating, pregnant, or planning to become pregnant
- •Patient planning on exposing the irradiated or control areas to the sun
研究组 & 干预措施
Polypodium Leucotomos Extract (PLE)
Patient will serve as their own control and will be exposed to 4 doses of visible light on one side of their back prior to receiving PLE.
PLE 240mg will be dispensed to patient after evaluation of Pre-PLE visible light doses are evaluated to be taken by the patient for a total of 28 day followed by exposure of the opposite side of the back with the same 4 doses of visible light as above
干预措施: Polypodium Leucotomos (Drug)
结局指标
主要结局
Difference in pigmentation pre and post administration of oral PLE
时间窗: 42 days
Detect differences in visible light induced pigmentation pre and post PLE using the following" 1. Investigator Global Assessment Scoring 2. Diffuse Reflectance Spectroscopy 3. Colorimetry 4. Biopsy with melanocyte and melanin stains among other tissue markers 5. Photography
次要结局
未报告次要终点
研究者
Iltefat Hamzavi
Principle Investigator
Henry Ford Health System