Green Tea Extract in Treating Patients With Actinic Keratosis
RATIONALE: Green tea extract contains ingredients that may inhibit the growth of actinic keratosis.
PURPOSE: Randomized phase II trial to determine the effectiveness of green tea extract in treating patients who have actinic keratosis.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
|Official Title:||A Randomized, Double-Blind, Placebo-Controlled Phase II Clinical Trial of Polyphenon E Against Various Endpoints of Actinic Keratosis Pathobiology|
- Clinical and histopathologic regression of actinic keratoses [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||March 2000|
|Primary Completion Date:||April 2010 (Final data collection date for primary outcome measure)|
Drug: kunecatechins ointment
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.
|United States, California|
|Chao Family Comprehensive Cancer Center|
|Orange, California, United States, 92868|
|Study Chair:||Frank L. Meyskens, MD, FACP||Chao Family Comprehensive Cancer Center|