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Green Tea Extract in Treating Patients With Actinic Keratosis
This study is ongoing, but not recruiting participants.
First Received: April 6, 2000   Last Updated: July 23, 2008   History of Changes
Sponsors and Collaborators: Chao Family Comprehensive Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00005097
  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 II

MedlinePlus related topics: Cancer Skin Cancer
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Randomized
Official Title: A Randomized, Double-Blind, Placebo-Controlled Phase II Clinical Trial of Polyphenon E Against Various Endpoints of Actinic Keratosis Pathobiology

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: March 2000
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
Chao Family Comprehensive Cancer Center
Investigators
Study Chair: Frank L. Meyskens, MD, FACP Chao Family Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000067798, UCIRVINE-N01-CN-85182, NCI-P00-0142
Study First Received: April 6, 2000
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00005097     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
squamous cell carcinoma of the skin

Study placed in the following topic categories:
Keratosis
Skin Diseases
Epidermoid Carcinoma
Squamous Cell Carcinoma
Skin Neoplasms
Carcinoma, Squamous Cell
Tylosis
Carcinoma

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Keratosis
Skin Diseases
Skin Neoplasms

ClinicalTrials.gov processed this record on May 07, 2009