Aging Clinical Trial
Official title:
Single-Blind Study Determining the Efficacy of Polypodium Leucotomos Extract Supplement in Decreasing UVA Premutagenic and Photoaging Markers
NCT number | NCT00520910 |
Other study ID # | 20070203 |
Secondary ID | |
Status | Completed |
Phase | Phase 2 |
First received | |
Last updated | |
Start date | August 2007 |
Est. completion date | May 2009 |
Verified date | June 2019 |
Source | University of Miami |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 10 |
Est. completion date | May 2009 |
Est. primary completion date | May 2009 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Miami Skin Research Group Office | Miami | Florida |
Lead Sponsor | Collaborator |
---|---|
University of Miami |
United States,
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. — View Citation
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. — View 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. — View Citation
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. — View Citation
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. — View Citation
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. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Common Deletion (CD) Value in DNA of Skin Biopsy Sample | CD is determined by semiquantitative real-time polymerase chain reaction. | baseline, 24 hours | |
Primary | 8-oxo-7,8-dihydro-2'-Deoxyguanosine (8-oxo-dG) Quantification in Skin Biopsy Sample Taken From Final Visit | 24 hours |
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