Back to resultsEfficacy of Polypodium Leucotomos Extract Decreasing UVA Premutagenic and Photoaging Markers
Primary Purpose
Aging, Skin Abnormalities
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Polypodium leucotomos
Sponsored by
About this trial
This is an interventional basic science trial for Aging focused on measuring Polypodium leucotomos, Ultraviolet Rays, Heliocare, calaguala, anapsos, Skin Aging and Damage
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
Sites / Locations
- University of Miami Skin Research Group Office
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Polypodium leucotomos extract
No intervention
Arm Description
Subject is given a 7.5 mg/kg dose of Polypodium leucotomos.
Subject is not given any treatment.
Outcomes
Primary Outcome Measures
Change in Common Deletion (CD) Value in DNA of Skin Biopsy Sample
CD is determined by semiquantitative real-time polymerase chain reaction.
8-oxo-7,8-dihydro-2'-Deoxyguanosine (8-oxo-dG) Quantification in Skin Biopsy Sample Taken From Final Visit
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00520910
Brief Title
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
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
August 2007 (Actual)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
May 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aging, Skin Abnormalities
Keywords
Polypodium leucotomos, Ultraviolet Rays, Heliocare, calaguala, anapsos, Skin Aging and Damage
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Polypodium leucotomos extract
Arm Type
Experimental
Arm Description
Subject is given a 7.5 mg/kg dose of Polypodium leucotomos.
Arm Title
No intervention
Arm Type
No Intervention
Arm Description
Subject is not given any treatment.
Intervention Type
Drug
Intervention Name(s)
Polypodium leucotomos
Other Intervention Name(s)
Heliocare
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Common Deletion (CD) Value in DNA of Skin Biopsy Sample
Description
CD is determined by semiquantitative real-time polymerase chain reaction.
Time Frame
baseline, 24 hours
Title
8-oxo-7,8-dihydro-2'-Deoxyguanosine (8-oxo-dG) Quantification in Skin Biopsy Sample Taken From Final Visit
Time Frame
24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian Berman, M.D., Ph.D.
Organizational Affiliation
University of Miami, Department of Dermatology and Cutaneous Surgery
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Miami Skin Research Group Office
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
12788523
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.
Results Reference
background
PubMed Identifier
16263237
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.
Results Reference
background
PubMed Identifier
12745244
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.
Results Reference
background
PubMed Identifier
14699363
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.
Results Reference
background
PubMed Identifier
15583582
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.
Results Reference
background
PubMed Identifier
15041750
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.
Results Reference
background
PubMed Identifier
9277148
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.
Results Reference
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Links:
URL
http://www.skininvestigation.com
Description
Skin Research Group Website
Learn more about this trial
Efficacy of Polypodium Leucotomos Extract Decreasing UVA Premutagenic and Photoaging Markers
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