Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02904798
Recruitment Status : Unknown
Verified September 2016 by Iltefat Hamzavi, Henry Ford Health System.
Recruitment status was:  Recruiting
First Posted : September 19, 2016
Last Update Posted : September 19, 2016
Sponsor:
Information provided by (Responsible Party):
Iltefat Hamzavi, Henry Ford Health System

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Photodermatoses Drug: Polypodium Leucotomos Not Applicable

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 22 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Study Start Date : July 2015
Estimated Primary Completion Date : February 2017
Estimated Study Completion Date : April 2017

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 Name: Helicocare




Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02904798


Contacts
Layout table for location contacts
Contact: Indermeet Kohli, Ph.D 313-916-6964 ikohli1@hfhs.org
Contact: Angela Parks-Miller 313-916-6964 aparks1@hfhs.org

Locations
Layout table for location information
United States, Michigan
Henry Ford Hospital Recruiting
Detroit, Michigan, United States, 48202
Contact: Indermeet Kohli, Ph.D.    313-916-6964    ikohli1@hfhs.org   
Contact: Angela Parks-Miller    313-916-6964    aparks1@hfhs.org   
Principal Investigator: Iltefat Hamzavi, M.D.         
Sponsors and Collaborators
Henry Ford Health System
Investigators
Layout table for investigator information
Principal Investigator: Iltefat H Hamzavi, MD Henry Ford Hospital
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Iltefat Hamzavi, Principle Investigator, Henry Ford Health System
ClinicalTrials.gov Identifier: NCT02904798    
Other Study ID Numbers: IRB#8385
First Posted: September 19, 2016    Key Record Dates
Last Update Posted: September 19, 2016
Last Verified: September 2016
Keywords provided by Iltefat Hamzavi, Henry Ford Health System:
sunscreen
photoprotection
visible light