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

Sponsored by:	University of Miami
Information provided by:	University of Miami
ClinicalTrials.gov Identifier:	NCT00520910

Purpose

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	Intervention	Phase
Aging Skin Abnormalities	Drug: Polypodium leucotomos Other: No Treatment	Phase II

MedlinePlus related topics: Dietary Supplements

Drug Information available for: BaseLine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Basic Science, Randomized, Single Blind (Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Single-Blind Study Determining the Efficacy of Polypodium Leucotomos Extract Supplement in Decreasing UVA Premutagenic and Photoaging Markers

Further study details as provided by University of Miami:

Primary Outcome Measures:

H&E study of skin biopsy sample taken from final visit [ Time Frame: 24 hours after Ultraviolet A treatment ] [ Designated as safety issue: Yes ]
PCR determination of common deletion in DNA of skin biopsy sample taken from final visit [ Time Frame: 24 hours after Ultraviolet A treatment ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]

Estimated Enrollment:	10
Study Start Date:	August 2007
Estimated Study Completion Date:	May 2009
Estimated Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 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.
2: No Intervention Subject is not given any treatment.	Other: No Treatment Patient is not given any treatment.

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Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00520910

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

Skin Research Group Website This link exits the ClinicalTrials.gov site

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

Alonso-Lebrero JL, Dominguez-Jimenez 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-Diaz F, Fitzpatrick TB, Gonzalez 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-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.

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:	University of Miami Miller School of Medicine ( Brian Berman, M.D., Ph.D. )
Study ID Numbers:	20070203
Study First Received:	August 24, 2007
Last Updated:	June 4, 2008
ClinicalTrials.gov Identifier:	NCT00520910
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Miami:

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

Study placed in the following topic categories:

Skin Diseases
Skin Abnormalities
Congenital Abnormalities

ClinicalTrials.gov processed this record on January 16, 2009