Phase 2
N=10
Efficacy of Polypodium Leucotomos Extract Decreasing UVA Premutagenic and Photoaging Markers
Aging · Skin Abnormalities
Bottom Line
View on ClinicalTrials.gov: NCT00520910 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Jun 2019
Primary outcome: Primary: Change in Common Deletion (CD) Value in DNA of Skin Biopsy Sample — -84; 217 percent change
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Polypodium leucotomos (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Miami
- Primary completion
- May 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Common Deletion (CD) Value in DNA of Skin Biopsy Sample |
-84; 217 | — |
| PRIMARY 8-oxo-7,8-dihydro-2'-Deoxyguanosine (8-oxo-dG) Quantification in Skin Biopsy Sample Taken From Final Visit |
— | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT00520910). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.