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

February 15, 2022 updated by: Iltefat Hamzavi, Henry Ford Health System
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Drug: Polypodium Leucotomos
- PL 240mg to be taken by the patient for 28 days prior to irradiation with visible light
Other Names:
  • Helicocare

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference in pigmentation pre and post administration of oral PLE
Time Frame: 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
42 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Henry Ford Health System

Investigators

  • Principal Investigator: Iltefat H Hamzavi, MD, Henry Ford Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2015

Primary Completion (Actual)

February 14, 2017

Study Completion (Actual)

April 23, 2017

Study Registration Dates

First Submitted

June 2, 2014

First Submitted That Met QC Criteria

September 13, 2016

First Posted (Estimate)

September 19, 2016

Study Record Updates

Last Update Posted (Actual)

March 3, 2022

Last Update Submitted That Met QC Criteria

February 15, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • IRB#8385

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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