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:||August 1999|
|Study Completion Date:||August 2002|
|Primary Completion Date:||August 2002 (Final data collection date for primary outcome measure)|
Experimental: Polyphenon E and Placebo
One arm will be assigned to be treated with topical Polyphenon E daily for 12 weeks and the other with placebo vehicle in a random, double blind manner daily for 12 weeks
Drug: Polyphenon E and Placebo
Areas of sun damaged skin with actinic keratoses to be treated will be mapped and photographed on patient's bilateral arms. One of the patient's arms will be assigned to be treated with topical Polyphenon E, the patient's other arm with placebo vehicle in a random, double blind manner. The patient's arm treatment areas will receive daily applications of a premeasured amount of drug or placebo. Patients will be seen every other week for 12 weeks to check for effects of the applications and monitor for compliance or possible side effects.
Other Name: 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00005097
|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|