Green Tea Extract in Treating Patients With Actinic Keratosis
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|ClinicalTrials.gov Identifier: NCT00005097|
Recruitment Status : Terminated (terminated due to the low conditional power for a positive study)
First Posted : April 2, 2004
Last Update Posted : April 5, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Non-melanomatous Skin Cancer||Drug: Polyphenon E and Placebo||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||88 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||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.|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Randomized, Double-Blind, Placebo-Controlled Phase II Clinical Trial of Polyphenon E Against Various Endpoints of Actinic Keratosis Pathobiology|
|Study Start Date :||August 1999|
|Actual Primary Completion Date :||August 2002|
|Actual Study Completion Date :||August 2002|
Experimental: Polyphenon E & Placebo
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.
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 and placebo
- Clinical and histopathologic regression of actinic keratoses [ Time Frame: 12 weeks ]Measure efficacy of Polyphenon E in causing complete and clinical and histopathologic regression of actinic keratoses in comparison to placebo
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|