The Effects of Visible Light on the Skin After Administration of Oral Polypodium Leucotomos
NCT ID: NCT02904798
Last Updated: 2022-03-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
22 participants
INTERVENTIONAL
2015-07-01
2017-04-23
Brief Summary
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Detailed Description
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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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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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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
Polypodium Leucotomos
\- PL 240mg to be taken by the patient for 28 days prior to irradiation with visible light
Interventions
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Polypodium Leucotomos
\- PL 240mg to be taken by the patient for 28 days prior to irradiation with visible light
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
100 Years
ALL
Yes
Sponsors
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Henry Ford Health System
OTHER
Responsible Party
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Iltefat Hamzavi
Principle Investigator
Principal Investigators
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Iltefat H Hamzavi, MD
Role: PRINCIPAL_INVESTIGATOR
Henry Ford Hospital
Locations
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Henry Ford Hospital
Detroit, Michigan, United States
Countries
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References
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Middelkamp-Hup MA, Bos JD, Rius-Diaz F, Gonzalez S, Westerhof W. Treatment of vitiligo vulgaris with narrow-band UVB and oral Polypodium leucotomos extract: a randomized double-blind placebo-controlled study. J Eur Acad Dermatol Venereol. 2007 Aug;21(7):942-50. doi: 10.1111/j.1468-3083.2006.02132.x.
Middelkamp-Hup MA, Pathak MA, Parrado C, Goukassian D, Rius-Diaz F, Mihm MC, Fitzpatrick TB, Gonzalez S. Oral Polypodium leucotomos extract decreases ultraviolet-induced damage of human skin. J Am Acad Dermatol. 2004 Dec;51(6):910-8. doi: 10.1016/j.jaad.2004.06.027.
Mahmoud BH, Hexsel CL, Hamzavi IH, Lim HW. Effects of visible light on the skin. Photochem Photobiol. 2008 Mar-Apr;84(2):450-62. doi: 10.1111/j.1751-1097.2007.00286.x. Epub 2008 Jan 29.
Kollias N, Baqer A. An experimental study of the changes in pigmentation in human skin in vivo with visible and near infrared light. Photochem Photobiol. 1984 May;39(5):651-9. doi: 10.1111/j.1751-1097.1984.tb03905.x. No abstract available.
Porges SB, Kaidbey KH, Grove GL. Quantification of visible light-induced melanogenesis in human skin. Photodermatol. 1988 Oct;5(5):197-200.
Mahmoud BH, Ruvolo E, Hexsel CL, Liu Y, Owen MR, Kollias N, Lim HW, Hamzavi IH. Impact of long-wavelength UVA and visible light on melanocompetent skin. J Invest Dermatol. 2010 Aug;130(8):2092-7. doi: 10.1038/jid.2010.95. Epub 2010 Apr 22.
Hamanaka H, Miyachi Y, Imamura S. Photoprotective effect of topically applied superoxide dismutase on sunburn reaction in comparison with sunscreen. J Dermatol. 1990 Oct;17(10):595-8. doi: 10.1111/j.1346-8138.1990.tb01702.x.
Mohammad TF, Kohli I, Nicholson CL, Treyger G, Chaowattanapanit S, Nahhas AF, Braunberger TL, Lim HW, Hamzavi IH. Oral Polypodium Leucotomos Extract and Its Impact on Visible Light-Induced Pigmentation in Human Subjects. J Drugs Dermatol. 2019 Dec 1;18(12):1198-1203.
Other Identifiers
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IRB#8385
Identifier Type: -
Identifier Source: org_study_id
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