The Effects of Visible Light on the Skin After Administration of Oral Polypodium Leucotomos
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|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
|Condition or disease||Intervention/treatment||Phase|
|Photodermatoses||Drug: Polypodium Leucotomos||Not Applicable|
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.
•Primary objective: Compare the effects of skin irradiated with visible light with and without oral polypodium leucotomos
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||22 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Study Start Date :||July 2015|
|Estimated Primary Completion Date :||February 2017|
|Estimated Study Completion Date :||April 2017|
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
- 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"
- Investigator Global Assessment Scoring
- Diffuse Reflectance Spectroscopy
- Biopsy with melanocyte and melanin stains among other tissue markers
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
|Contact: Indermeet Kohli, Ph.Demail@example.com|
|Contact: Angela Parks-Millerfirstname.lastname@example.org|
|Principal Investigator:||Iltefat H Hamzavi, MD||Henry Ford Hospital|