Green Tea Extract in Treating Patients With Actinic Keratosis

This study has been terminated.
(terminated due to the low conditional power for a positive study)
Sponsor:
Collaborators:
Chao Family Comprehensive Cancer Center
Information provided by:
University of California, Irvine
ClinicalTrials.gov Identifier:
NCT00005097
First received: April 6, 2000
Last updated: October 11, 2010
Last verified: October 2010
  Purpose

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 Intervention Phase
Non-melanomatous Skin Cancer
Drug: kunecatechins ointment
Phase 2

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by University of California, Irvine:

Primary Outcome Measures:
  • Clinical and histopathologic regression of actinic keratoses [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: March 2000
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: kunecatechins ointment
    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.
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS: Clinically and histologically confirmed grade 1-3 actinic keratoses At least 2 actinic keratoses on each arm

PATIENT CHARACTERISTICS: Age: Over 18 Performance status: SWOG 0-1 Karnofsky 70-100% Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: No prior invasive malignancy within past 5 years except nonmelanomatous skin cancer, stage I carcinoma in situ of the cervix, or stage 0 chronic lymphocytic leukemia No severe metabolic disorder No life threatening acute or chronic disease No medical condition that would preclude study No active systemic infectious disease that may affect immune system No prior keloid formation Not pregnant or nursing Negative pregnancy test

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 2 months since prior immunotherapy Chemotherapy: At least 2 months since prior topical application of fluorouracil or masoprocol for actinic keratoses At least 2 months since prior systemic chemotherapy No further anticipated chemotherapy Endocrine therapy: At least 2 weeks since prior topical corticosteroids to target lesions At least 4 weeks since prior systemic steroid therapy Radiotherapy: No anticipated radiotherapy Surgery: Not specified Other: At least 2 weeks since prior other topical medications (e.g., retinoids or alpha hydroxyacids such as glycolic acid or lactic acid) At least 2 months since prior cryotherapy to target lesions At least 2 months since prior systemic psoralens or retinoids At least 2 months since prior laser resurfacing or chemical peels At least 30 days since prior other investigational drug No other concurrent topical medication to areas being studied

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00005097

Locations
United States, California
Chao Family Comprehensive Cancer Center
Orange, California, United States, 92868
Sponsors and Collaborators
University of California, Irvine
Chao Family Comprehensive Cancer Center
Investigators
Study Chair: Frank L. Meyskens, MD, FACP Chao Family Comprehensive Cancer Center
  More Information

No publications provided

Responsible Party: Frank L. Meyskens, Jr, University of California, Irvine
ClinicalTrials.gov Identifier: NCT00005097     History of Changes
Other Study ID Numbers: CDR0000067798, UCIRVINE-N01-CN-85182, NCI-P00-0142
Study First Received: April 6, 2000
Last Updated: October 11, 2010
Health Authority: United States: Federal Government

Keywords provided by University of California, Irvine:
squamous cell carcinoma of the skin

Additional relevant MeSH terms:
Skin Neoplasms
Keratosis
Keratosis, Actinic
Neoplasms by Site
Neoplasms
Skin Diseases
Precancerous Conditions

ClinicalTrials.gov processed this record on April 15, 2014