The Effects of Visible Light on the Skin After Administration of Oral Polypodium Leucotomos

Study Overview
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Brief Summary
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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.

Detailed Description
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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: •Primary objective: Compare the effects of skin irradiated with visible light with and without oral polypodium leucotomos

Conditions
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Photodermatoses

Intervention / Treatment
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* Drug: Polypodium Leucotomos


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Polypodium Leucotomos Extract (PLE)<br>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 | Drug: Polypodium Leucotomos<br>* - PL 240mg to be taken by the patient for 28 days prior to irradiation with visible light<br>* Other names: Helicocare;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in pigmentation pre and post administration of oral PLE | Detect differences in visible light induced pigmentation pre and post PLE using the following Investigator Global Assessment Scoring Diffuse Reflectance Spectroscopy Colorimetry Biopsy with melanocyte and melanin stains among other tissue markers Photography | 42 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sunscreen, photoprotection, visible light