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| Tracking Information | |||||
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| First Received Date ICMJE | April 6, 2000 | ||||
| Last Updated Date | July 23, 2008 | ||||
| Start Date ICMJE | March 2000 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE | |||||
| Original Primary Outcome Measures ICMJE | |||||
| Change History | Complete list of historical versions of study NCT00005097 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Green Tea Extract in Treating Patients With Actinic Keratosis | ||||
| Official Title ICMJE | A Randomized, Double-Blind, Placebo-Controlled Phase II Clinical Trial of Polyphenon E Against Various Endpoints of Actinic Keratosis Pathobiology | ||||
| 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. |
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| 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. |
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| Study Phase | Phase II | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Prevention, Randomized | ||||
| Condition ICMJE | Non-Melanomatous Skin Cancer | ||||
| Intervention ICMJE | Drug: kunecatechins ointment | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Enrollment ICMJE | |||||
| Completion Date | |||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | 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 |
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00005097 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | CDR0000067798, UCIRVINE-N01-CN-85182, NCI-P00-0142 | ||||
| Study Sponsor ICMJE | Chao Family Comprehensive Cancer Center | ||||
| Collaborators ICMJE | National Cancer Institute (NCI) | ||||
| Investigators ICMJE |
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| Information Provided By | National Cancer Institute (NCI) | ||||
| Verification Date | June 2007 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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