A Randomized, Double-Blind, Placebo-Controlled Phase II Clinical Trial of Polyphenon E Against Various Endpoints of Actinic Keratosis Pathobiology

Study start date: August 1, 1999

Inclusion Criteria: 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). Exclusion Criteria: 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 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. 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