Overview

This trial is active, not recruiting.

Conditions aging, skin abnormalities
Treatments polypodium leucotomos, no treatment
Phase phase 2
Sponsor University of Miami
Start date August 2007
End date May 2009
Trial size 10 participants
Trial identifier NCT00520910, 20070203

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (investigator)
Primary purpose basic science
Arm
(Experimental)
Subject is given a 7.5 mg/kg dose of Polypodium leucotomos.
polypodium leucotomos Heliocare
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.
(No Intervention)
Subject is not given any treatment.
no treatment
Patient is not given any treatment.

Primary Outcomes

Measure
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

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Single-Blind Study Determining the Efficacy of Polypodium Leucotomos Extract Supplement in Decreasing UVA Premutagenic and Photoaging Markers
Principal investigator Brian Berman, M.D., Ph.D.
Description Screening Visit: You will read and be explained the informed consent. If you agree to participate you will sign the informed consent and a copy will be given to you. Your medical history and the exclusion/inclusion criteria will be reviewed. Pictures are going to be taken from both forearms with a Nikon camera in each visit . If you are a woman in childbearing age you will be asked to take a urine pregnancy test at the research office at baseline (day 0) and final visit. If you qualify you will be given an appointment for baseline visit (day 0). Baseline visit (day 0): You will be randomly (by chance) assigned to either PL supplement or no treatment. You will be instructed not to change any of your practices towards the sun during the duration of the study, including time spent outdoors each weekday and weekend day, with special attention between the hours of 10 AM to 4PM. You will also be asked about sunscreen use and the parts of your body where you apply it. You may not apply sunscreen to the anterior aspect of your forearms (the part of your forearm that continues with your palm) during the length of you participation in our study. As a procedure during this visit, previous local anesthesia, a 3 mm skin biopsy from your right forearm will be taken. Then, 4 different small square areas or your left forearm (18mm each) will be exposed to a source of UVA for a few seconds. Supplies and wound care instructions for the biopsied site will be given to you, as well as an appointment to return in 24 hours. Follow up visit 1: You will be asked about adverse events since your last visit. The study doctor will examine your left arm and determine the amount of redness present. You will be given an appointment to return for follow up. Follow up visit 2: You will be asked about adverse events since your last visit. If you were assigned to take the study medication, PL, you will have to take one dose 8 hours and another dose 2 hours prior to beginning of visit 2. Three different small square areas (18mm each) of your right forearm will be exposed to different doses of UVA for a few seconds. You should return any unused medication. You will be given an appointment to return in 24 hours. Final visit: You will be asked about adverse events since your last visit. Three 3 mm skin biopsies will be taken from within the previously irradiated squares. Supplies and wound care instructions for the biopsied site will be given to you. If you are a woman in childbearing age you will be asked to take a urine pregnancy test. You will be paid. Note: The skin around the areas to be tested during this study will be protected with a UVA opaque material. If you experience redness with burning and tenderness, you will be allowed to use twice a day hydrocortisone 1%, over the counter cream, to treat the affected area. You may contact research personnel for wound care follow-up up to one month beyond the final visit, if necessary. During the course of the study, pictures of the forearms will be taken on each visit.
Trial information was received from ClinicalTrials.gov and was last updated in October 2010.
Information provided to ClinicalTrials.gov by University of Miami.