Clinical trial NCT00520910: Efficacy of Polypodium Leucotomos Extract Decreasing UVA Premutagenic and Photoaging Markers
Official title: Single-Blind Study Determining the Efficacy of Polypodium Leucotomos Extract Supplement in Decreasing UVA Premutagenic and Photoaging Markers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Aging
Skin Abnormalities
Keywords: Polypodium leucotomos, Ultraviolet Rays, Heliocare, calaguala, anapsos
Skin Aging and Damage
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2007-08-27
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: With this study, the investigators 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.


Eligibility 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

Primary outcomes:
measure: Change in Common Deletion (CD) Value in DNA of Skin Biopsy Sample
timeFrame: baseline, 24 hours
measure: 8-oxo-7,8-dihydro-2'-Deoxyguanosine (8-oxo-dG) Quantification in Skin Biopsy Sample Taken From Final Visit
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami Skin Research Group Office
state: Florida
Study officials:
affiliation: University of Miami, Department of Dermatology and Cutaneous Surgery
name: Brian Berman, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1016/s0923-1811(03)00042-2.
citation: 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. doi: 10.1016/j.tiv.2005.09.008. Epub 2005 Nov 2.
citation: 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. doi: 10.1016/s1011-1344(03)00051-4.
citation: 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. doi: 10.1016/s0190-9622(03)02732-4.
citation: 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.
citation: 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. doi: 10.1073/pnas.0401141101. Epub 2004 Mar 23.
citation: 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. doi: 10.1111/j.1751-1097.1997.tb08654.x.