Single-Blind Study Determining the Efficacy of Polypodium Leucotomos Extract Supplement in Decreasing Ultraviolet A (UVA) Premutagenic and Photoaging Markers (Heliocare)

Study Description

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Brief Summary:

With this study we will like to determine if taking a dose of the study medication, called Polypodium leucotomos (PL), prevents some of the changes in the skin caused by the adverse effects of UVA, a type of ultraviolet light. Ultraviolet light is a form of radiation which is not visible to the human eye. The sun produces different types of ultraviolet radiation, and UVA is one of them. More than 95% of the solar UV energy that reaches our skin is from the UVA type. UVA penetrates cloud cover and glass windows.

PL extract comes from a tropical fern plant grown in Central and South America, and it is a dietary supplement available in the US. No side effects have been reported with Polypodium leucotomos extract since becoming commercially available in 1982. Also, PL extract was approved for oral use by the Institutional Review Board of The Massachusetts General Hospital, Boston, for studies by Harvard Medical School faculty in human volunteers that were carried out for a period of two years, using artificial light and sunlight as ultraviolet sources.

This is an investigator-blinded study, which means that the doctor evaluating you will not know if you are receiving the study medication or not. Another doctor will be supplying you with the medication and discussing any problems that you may have with the medication.

You will be assigned to one of the two treatment groups. The group will be assigned by chance and you will have a one in two chances of receiving either the study medication or no treatment.

Condition or disease	Intervention/treatment	Phase
Aging; Skin Abnormalities	Drug: Polypodium leucotomos; Other: No Treatment	Phase 2

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Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	10 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Single (Investigator)
Primary Purpose:	Basic Science
Official Title:	Single-Blind Study Determining the Efficacy of Polypodium Leucotomos Extract Supplement in Decreasing UVA Premutagenic and Photoaging Markers
Study Start Date :	August 2007
Estimated Primary Completion Date :	May 2009
Estimated Study Completion Date :	May 2009

Arms and Interventions

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Arm	Intervention/treatment
Experimental: 1; Subject is given a 7.5 mg/kg dose of Polypodium leucotomos.	Drug: Polypodium leucotomos; Subject is given a 7.5 mg/kg oral dose of Polypodium leucotomos during Baseline visit, and again at 8 hours and 2 hours before the Follow-up visit #2.; Other Name: Heliocare
No Intervention: 2; Subject is not given any treatment.	Other: No Treatment; Patient is not given any treatment.

Outcome Measures

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Primary Outcome Measures :

1. H&E study of skin biopsy sample taken from final visit [ Time Frame: 24 hours after Ultraviolet A treatment ]
2. PCR determination of common deletion in DNA of skin biopsy sample taken from final visit [ Time Frame: 24 hours after Ultraviolet A treatment ]
3. 8-oxo-7,8-dihydro-2'-deoxyguanosine (8-oxo-dG) quantification in skin biopsy sample taken from final visit [ Time Frame: 24 hours after Ultraviolet A treatment ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

• Healthy subjects,
• 18 years of age or older,
• with Fitzpatrick skin types II and III.

Exclusion Criteria:

• Pregnancy
• Personal history of skin cancer
• History of abnormal photosensitivity
• Smokers
• Patients with history or being exposed to other forms of radiation (other than sunlight)
• History or current exposure to asbestos
• Patients taking any drug that might alter the response of skin to UVR (including, but are not limited to, doxycycline, sulfas, psoralens, and amiodarone)
• Patients unable to undergo skin biopsies
• History of abnormal scarring
• History of adverse reaction to local anesthesia

Contacts and Locations

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Locations

United States, Florida
University of Miami Skin Research Group Office
Miami, Florida, United States, 33136

Sponsors and Collaborators

University of Miami

Investigators

Principal Investigator:	Brian Berman, M.D., Ph.D.	University of Miami, Department of Dermatology and Cutaneous Surgery

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

Skin Research Group Website 

Publications:

Philips N, Smith J, Keller T, Gonzalez S. Predominant effects of Polypodium leucotomos on membrane integrity, lipid peroxidation, and expression of elastin and matrixmetalloproteinase-1 in ultraviolet radiation exposed fibroblasts, and keratinocytes. J Dermatol Sci. 2003 Jun;32(1):1-9.

Gombau L, García F, Lahoz A, Fabre M, Roda-Navarro P, Majano P, Alonso-Lebrero JL, Pivel JP, Castell JV, Gómez-Lechon MJ, González S. Polypodium leucotomos extract: antioxidant activity and disposition. Toxicol In Vitro. 2006 Jun;20(4):464-71. Epub 2005 Nov 2.

Alonso-Lebrero JL, Domínguez-Jiménez C, Tejedor R, Brieva A, Pivel JP. Photoprotective properties of a hydrophilic extract of the fern Polypodium leucotomos on human skin cells. J Photochem Photobiol B. 2003 Apr;70(1):31-7.

Middelkamp-Hup MA, Pathak MA, Parrado C, Garcia-Caballero T, Rius-Díaz F, Fitzpatrick TB, González S. Orally administered Polypodium leucotomos extract decreases psoralen-UVA-induced phototoxicity, pigmentation, and damage of human skin. J Am Acad Dermatol. 2004 Jan;50(1):41-9.

Middelkamp-Hup MA, Pathak MA, Parrado C, Goukassian D, Rius-Díaz F, Mihm MC, Fitzpatrick TB, González S. Oral Polypodium leucotomos extract decreases ultraviolet-induced damage of human skin. J Am Acad Dermatol. 2004 Dec;51(6):910-8.

Agar NS, Halliday GM, Barnetson RS, Ananthaswamy HN, Wheeler M, Jones AM. The basal layer in human squamous tumors harbors more UVA than UVB fingerprint mutations: a role for UVA in human skin carcinogenesis. Proc Natl Acad Sci U S A. 2004 Apr 6;101(14):4954-9. Epub 2004 Mar 23.

Berneburg M, Gattermann N, Stege H, Grewe M, Vogelsang K, Ruzicka T, Krutmann J. Chronically ultraviolet-exposed human skin shows a higher mutation frequency of mitochondrial DNA as compared to unexposed skin and the hematopoietic system. Photochem Photobiol. 1997 Aug;66(2):271-5.

Responsible Party:	Brian Berman, M.D., Ph.D., University of Miami Miller School of Medicine
ClinicalTrials.gov Identifier:	NCT00520910 History of Changes
Other Study ID Numbers:	20070203
First Posted:	August 27, 2007
Last Update Posted:	October 19, 2010
Last Verified:	June 2008

Keywords provided by University of Miami:

Polypodium leucotomos, Ultraviolet Rays, Heliocare, calaguala, anapsos; Skin Aging and Damage

Additional relevant MeSH terms:

Skin Abnormalities; Congenital Abnormalities; Skin Diseases