A Randomized, Double-Blind, Placebo-Controlled Phase II Clinical Trial of Polyphenon E Against Various Endpoints of Actinic Keratosis Pathobiology
OBJECTIVES: I. Determine the efficacy of the green tea extract epigallocatechin gallate
(Polyphenon E topical ointment) in causing complete clinical and histopathologic regression
in patients with actinic keratoses. II. Determine duration of treatment with Polyphenon E
necessary to cause regression in these patients. III. Describe pathophysiologic and
molecular alterations in actinic keratoses and sun damaged skin that are not present in skin
that is not sun damaged in these patients. IV. Determine the effects of this treatment on
biomarkers for skin cancer in these patients.
OUTLINE: This is a randomized, double blind, placebo controlled study. One of the patient's
arms is randomized to receive topical epigallocatechin gallate (Polyphenon E), the other arm
to receive a placebo. Patients receive topical applications daily for 12 weeks, or until
resolution of all actinic keratoses within the treatment field.
PROJECTED ACCRUAL: A minimum of 60 patients will be accrued for this study over 10 months.
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
Clinical and histopathologic regression of actinic keratoses
Frank L. Meyskens, MD, FACP
Chao Family Comprehensive Cancer Center
United States: Federal Government
|Chao Family Comprehensive Cancer Center||Orange, California 92868|