Green Tea Extract in Treating Patients With Actinic Keratosis

NCT00005097 | Terminated Phase 2 DMC

• 5 other identifiers: UCI 98-31 / CDR0000067798UCIRVINE-N01-CN-85182NCI-P00-0142UCI 98-311998-420
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-melanomatous Skin Cancer

Keywords

squamous cell carcinoma of the skin

Outcome Measures

Primary Outcomes (1)

• Clinical and histopathologic regression of actinic keratoses

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

  12 weeks

Study Arms (1)

Polyphenon E & Placebo

EXPERIMENTAL

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

Interventions

Polyphenon E and Placebo DRUG

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.

Also known as: kunecatechins ointment and placebo

Polyphenon E & Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.
• Not requiring use of topical medications in areas being studied.
• 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 \[Karnofsky scale 70 - 80\]).
• Signed informed consent approved by the local Human Subjects Committee (Institutional Review Board).

You may not qualify if:

• 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).
• Any medical condition which , in the opinion of the investigator, could preclude study participation
• Use of any investigational drug in the previous 30 days.
• Any history of keloid formation.
• Pregnant or nursing patients.
• 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

Sponsors & Collaborators

• Frank Meyskens: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Chao Family Comprehensive Cancer Center

Orange, California, 92868, United States

Location

Related Publications (2)

• Carpenter PM, Linden KG, McLaren CE, Li KT, Arain S, Barr RJ, Hite P, Sun JD, Meyskens FL Jr. Nuclear morphometry and molecular biomarkers of actinic keratosis, sun-damaged, and nonexposed skin. Cancer Epidemiol Biomarkers Prev. 2004 Dec;13(12):1996-2002.

  PMID: 15598753 RESULT

• Linden KG, Carpenter PM, McLaren CE, Barr RJ, Hite P, Sun JD, Li KT, Viner JL, Meyskens FL. Chemoprevention of nonmelanoma skin cancer: experience with a polyphenol from green tea. Recent Results Cancer Res. 2003;163:165-71; discussion 264-6. doi: 10.1007/978-3-642-55647-0_15.

  PMID: 12903852 RESULT

MeSH Terms

Interventions

polyphenon E

Study Officials

• Frank L. Meyskens, MD, FACP

  Chao Family Comprehensive Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Cancer Center

Model Details: 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.

Study Record Dates

• First Submitted: April 6, 2000
• First Posted: April 2, 2004
• Study Start: August 1, 1999
• Primary Completion: August 1, 2002
• Study Completion: August 1, 2002
• Last Updated: April 5, 2018

Record last verified: 2018-04

Locations

US (1)