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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
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Frank Meyskens, University of California, Irvine

Brief Summary:

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

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 88 participants
Allocation: Randomized
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)
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
Study Start Date : August 1999
Actual Primary Completion Date : August 2002
Actual Study Completion Date : August 2002

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. participants multiple sites of actinic keratosis identified by clinical examination and the histologic confirmation of one lesion (Grade 1-3 as defined previously in "Clinical Grading") are eligible.
  2. No history of invasive cancer within 5 years (though non-melanoma skin cancer, stage I cervical cancer, or chronic lymphocytic leukemia (CLL) stage 0 will not be reason to exclude a patient); no severe metabolic disorders or other life-threatening acute or chronic disease; no additional x-ray or chemotherapy anticipated.
  3. Not requiring use of topical medications in areas being studied.
  4. Subjects must meet the Southwest Oncology Group performance status criteria of 0 - 1 (0= fully active, able to carry on all pre-disease activities without restriction [Karnofsky scale 90 - 100]; 1 = restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature, i.e. light housework or office work [Karnofsky scale 70 - 80]).
  5. Signed informed consent approved by the local Human Subjects Committee (Institutional Review Board).

Exclusion Criteria:

  1. Use of the following systemic or local therapies for the periods specified, prior to entry into the study:

    Within 2 weeks: topical medications, e.g. corticosteroids, alpha-hydroxyacids (glycolic acid, lactic acid) or retinoids (Retin-A) to the target lesions Within 4 weeks: systemic steroid therapy. Within 2 months: cryotherapy to the target lesions, laser resurfacing, chemical peels, topical application of 5-fluorouracil (5-FU) or masoprocol (Actinex) for treatment of actinic keratoses. Systemic treatment with chemotherapeutic agents, psoralens, immunotherapy, retinoids (Tegison, Accutane).

  2. Any medical condition which , in the opinion of the investigator, could preclude study participation
  3. Active infectious diseases such as tuberculosis (TB) or HIV that may affect the patient systemically and may also affect the immune system. Localized, minor infections such as sinusitis, uncomplicated urinary tract infection, otitis media, etc. will not be criteria for exclusion from the study.
  4. Use of any investigational drug in the previous 30 days.
  5. Any history of keloid formation.
  6. Pregnant or nursing patients.
  7. Participants who may be unreliable for the study, including those engaging in excessive alcohol intake or drug abuse, or participants who are unable to return for scheduled follow-up visits

Information from the National Library of Medicine

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


Locations
United States, California
Chao Family Comprehensive Cancer Center
Orange, California, United States, 92868
Sponsors and Collaborators
Frank Meyskens
National Cancer Institute (NCI)
Investigators
Study Chair: Frank L. Meyskens, MD, FACP Chao Family Comprehensive Cancer Center

Publications of Results:
Responsible Party: Frank Meyskens, Cancer Center, University of California, Irvine
ClinicalTrials.gov Identifier: NCT00005097     History of Changes
Other Study ID Numbers: UCI 98-31 / CDR0000067798
UCIRVINE-N01-CN-85182 ( Other Identifier: UC Irvine )
NCI-P00-0142 ( Registry Identifier: National Cancer Insitute )
UCI 98-31 ( Other Identifier: University of California, Irvine )
1998-420 ( Other Identifier: University of California, Irvine )
First Posted: April 2, 2004    Key Record Dates
Last Update Posted: April 5, 2018
Last Verified: April 2018

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

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