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Efficacy of Polypodium Leucotomos Extract Decreasing UVA Premutagenic and Photoaging Markers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00520910
Recruitment Status : Completed
First Posted : August 27, 2007
Results First Posted : June 18, 2019
Last Update Posted : June 18, 2019
Information provided by (Responsible Party):
Robert S. Kirsner, University of Miami

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.

Condition or disease Intervention/treatment Phase
Aging Skin Abnormalities Drug: Polypodium leucotomos Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Basic Science
Official Title: Single-Blind Study Determining the Efficacy of Polypodium Leucotomos Extract Supplement in Decreasing UVA Premutagenic and Photoaging Markers
Actual Study Start Date : August 2007
Actual Primary Completion Date : May 2009
Actual Study Completion Date : May 2009

Arm Intervention/treatment
Experimental: Polypodium leucotomos extract
Subject is given a 7.5 mg/kg dose of Polypodium leucotomos.
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.
Other Name: Heliocare

No Intervention: No intervention
Subject is not given any treatment.

Primary Outcome Measures :
  1. Change in Common Deletion (CD) Value in DNA of Skin Biopsy Sample [ Time Frame: baseline, 24 hours ]
    CD is determined by semiquantitative real-time polymerase chain reaction.

  2. 8-oxo-7,8-dihydro-2'-Deoxyguanosine (8-oxo-dG) Quantification in Skin Biopsy Sample Taken From Final Visit [ Time Frame: 24 hours ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00520910

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United States, Florida
University of Miami Skin Research Group Office
Miami, Florida, United States, 33136
Sponsors and Collaborators
University of Miami
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Principal Investigator: Brian Berman, M.D., Ph.D. University of Miami, Department of Dermatology and Cutaneous Surgery
Additional Information:

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Responsible Party: Robert S. Kirsner, Professor, University of Miami Identifier: NCT00520910    
Other Study ID Numbers: 20070203
First Posted: August 27, 2007    Key Record Dates
Results First Posted: June 18, 2019
Last Update Posted: June 18, 2019
Last Verified: June 2019
Keywords provided by Robert S. Kirsner, University of Miami:
Polypodium leucotomos, Ultraviolet Rays, Heliocare, calaguala, anapsos
Skin Aging and Damage
Additional relevant MeSH terms:
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Skin Abnormalities
Congenital Abnormalities
Skin Diseases