Single-Blind Study Determining the Efficacy of Polypodium Leucotomos Extract Supplement in Decreasing Ultraviolet A (UVA) Premutagenic and Photoaging Markers (Heliocare)
![]() |
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. |
ClinicalTrials.gov Identifier: NCT00520910 |
Recruitment Status
: Unknown
Verified June 2008 by University of Miami.
Recruitment status was: Active, not recruiting
First Posted
: August 27, 2007
Last Update Posted
: October 19, 2010
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
With this study we 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. Ultraviolet light is a form of radiation which is not visible to the human eye. The sun produces different types of ultraviolet radiation, and UVA is one of them. More than 95% of the solar UV energy that reaches our skin is from the UVA type. UVA penetrates cloud cover and glass windows.
PL extract comes from a tropical fern plant grown in Central and South America, and it is a dietary supplement available in the US. No side effects have been reported with Polypodium leucotomos extract since becoming commercially available in 1982. Also, PL extract was approved for oral use by the Institutional Review Board of The Massachusetts General Hospital, Boston, for studies by Harvard Medical School faculty in human volunteers that were carried out for a period of two years, using artificial light and sunlight as ultraviolet sources.
This is an investigator-blinded study, which means that the doctor evaluating you will not know if you are receiving the study medication or not. Another doctor will be supplying you with the medication and discussing any problems that you may have with the medication.
You will be assigned to one of the two treatment groups. The group will be assigned by chance and you will have a one in two chances of receiving either the study medication or no treatment.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Aging Skin Abnormalities | Drug: Polypodium leucotomos Other: No Treatment | Phase 2 |

Study Type : | Interventional (Clinical Trial) |
Estimated 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 |
Study Start Date : | August 2007 |
Estimated Primary Completion Date : | May 2009 |
Estimated Study Completion Date : | May 2009 |

Arm | Intervention/treatment |
---|---|
Experimental: 1
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: 2
Subject is not given any treatment.
|
Other: No Treatment
Patient is not given any treatment.
|
- H&E study of skin biopsy sample taken from final visit [ Time Frame: 24 hours after Ultraviolet A treatment ]
- PCR determination of common deletion in DNA of skin biopsy sample taken from final visit [ Time Frame: 24 hours after Ultraviolet A treatment ]
- 8-oxo-7,8-dihydro-2'-deoxyguanosine (8-oxo-dG) quantification in skin biopsy sample taken from final visit [ Time Frame: 24 hours after Ultraviolet A treatment ]

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.
Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
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

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 ClinicalTrials.gov identifier (NCT number): NCT00520910
United States, Florida | |
University of Miami Skin Research Group Office | |
Miami, Florida, United States, 33136 |
Principal Investigator: | Brian Berman, M.D., Ph.D. | University of Miami, Department of Dermatology and Cutaneous Surgery |
Additional Information:
Publications:
Responsible Party: | Brian Berman, M.D., Ph.D., University of Miami Miller School of Medicine |
ClinicalTrials.gov Identifier: | NCT00520910 History of Changes |
Other Study ID Numbers: |
20070203 |
First Posted: | August 27, 2007 Key Record Dates |
Last Update Posted: | October 19, 2010 |
Last Verified: | June 2008 |
Keywords provided by University of Miami:
Polypodium leucotomos, Ultraviolet Rays, Heliocare, calaguala, anapsos Skin Aging and Damage |
Additional relevant MeSH terms:
Skin Abnormalities Congenital Abnormalities Skin Diseases |