Neoplasms

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Skin and Connective Tissue Diseases

Carcinoma

Skin Neoplasms

Carcinoma, Squamous Cell

Keratosis, Actinic

Keratosis

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Herbal and Botanical

All Drugs and Chemicals

Each subject will receive both the Polyphenon E and placebo, one on each arm.

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.

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.

Polyphenon E and Placebo

Frank L. Meyskens, MD, FACP

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.

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.

Subjects will have actinic keratosis on both arms and apply Polyphenon E topical ointment on one arm and placebo ointment to apply to the other arm. Subjects will serve as their own control by being unaware of which arm will have the active study drug.

Green Tea Extract in Treating Patients With Actinic Keratosis

A Randomized, Double-Blind, Placebo-Controlled Phase II Clinical Trial of Polyphenon E Against Various Endpoints of Actinic Keratosis Pathobiology

Measure efficacy of Polyphenon E in causing complete and clinical and histopathologic regression of actinic keratoses in comparison to placebo

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Green Tea Extract in Treating Patients With Actinic Keratosis	NCT00005097	Non-melanomatou...	Polyphenon E an...	18 Years -	University of California, Irvine
Green Tea Extract in Treating Patients With Actinic Keratosis	NCT00005097	Non-melanomatou...	Polyphenon E an...	18 Years -	University of California, Irvine

Spots Global Cancer Trial Database for polyphenon e and placebo