Efficacy of Polypodium Leucotomos Extract Decreasing UVA Premutagenic and Photoaging Markers
Phase 2
Completed
- Conditions
- Skin AbnormalitiesAging
- Interventions
- Drug: Polypodium leucotomos
- Registration Number
- NCT00520910
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 10
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Polypodium leucotomos extract Polypodium leucotomos Subject is given a 7.5 mg/kg dose of Polypodium leucotomos.
- Primary Outcome Measures
Name Time Method Change in Common Deletion (CD) Value in DNA of Skin Biopsy Sample baseline, 24 hours 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 24 hours
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University of Miami Skin Research Group Office
🇺🇸Miami, Florida, United States