Efficacy of Polypodium Leucotomos Extract Decreasing UVA Premutagenic and Photoaging Markers

Aging Clinical Trial

Official title:

Single-Blind Study Determining the Efficacy of Polypodium Leucotomos Extract Supplement in Decreasing UVA Premutagenic and Photoaging Markers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00520910
• Other study ID #: 20070203
• Status: Completed
• Phase: Phase 2
• Start date: August 2007
• Est. completion date: May 2009

Study information

• Verified date: June 2019
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Aging
• Skin Abnormalities

Intervention

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.

Locations

Country	Name	City	State
United States	University of Miami Skin Research Group Office	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Miami

Country where clinical trial is conducted

United States, 

References & Publications (7)

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

Outcome

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

External Links

•   Skin Research Group Website