Efficacy of Polypodium Leucotomos Extract Decreasing UVA Premutagenic and Photoaging Markers

NCT00520910 | Completed Phase 2 Results

• 1 other identifier: 20070203
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Aging; Skin Abnormalities

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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

• 8-oxo-7,8-dihydro-2'-Deoxyguanosine (8-oxo-dG) Quantification in Skin Biopsy Sample Taken From Final Visit

  24 hours

Study Arms (2)

Polypodium leucotomos extract

EXPERIMENTAL

Subject is given a 7.5 mg/kg dose of Polypodium leucotomos.

Drug: Polypodium leucotomos

No intervention

NO INTERVENTION

Subject is not given any treatment.

Interventions

Polypodium leucotomos DRUG

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.

Also known as: Heliocare

Polypodium leucotomos extract

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Miami: lead

Study Sites (1)

University of Miami Skin Research Group Office

Miami, Florida, 33136, United States

Location

Related Publications (7)

• 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.

  PMID: 12788523 BACKGROUND

• 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.

  PMID: 16263237 BACKGROUND

• 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.

  PMID: 12745244 BACKGROUND

• 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.

  PMID: 14699363 BACKGROUND

• 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.

  PMID: 15583582 BACKGROUND

• 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.

  PMID: 15041750 BACKGROUND

• 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.

  PMID: 9277148 BACKGROUND

Related Links

• Skin Research Group Website

MeSH Terms

Conditions

Skin Abnormalities

Condition Hierarchy (Ancestors)

Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Dr. Robert Kirsner
• Organization: University of Miami

RKirsner@med.miami.edu

305-243-4472

Study Officials

• Brian Berman, M.D., Ph.D.

  University of Miami, Department of Dermatology and Cutaneous Surgery

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 24, 2007
• First Posted: August 27, 2007
• Study Start: August 1, 2007
• Primary Completion: May 1, 2009
• Study Completion: May 1, 2009
• Last Updated: June 18, 2019
• Results First Posted: June 18, 2019

Record last verified: 2019-06

Locations

US (1)