Efficacy of Polypodium Leucotomos Extract Decreasing UVA Premutagenic and Photoaging Markers

Phase 2CompletedNCT00520910

University of Miami10 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

SINGLE

Enrollment

Conditions

Aging Skin Abnormalities

Interventions

Polypodium leucotomosDRUG

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.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

University of Miami Skin Research Group Office

Miami, Florida, United States

Outcomes

Primary Outcomes

Change in Common Deletion (CD) Value in DNA of Skin Biopsy Sample

CD is determined by semiquantitative real-time polymerase chain reaction.

Time frame: baseline, 24 hours

8-oxo-7,8-dihydro-2'-Deoxyguanosine (8-oxo-dG) Quantification in Skin Biopsy Sample Taken From Final Visit

Time frame: 24 hours

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.