|
Green Tea Extract in Treating Patients With Actinic Keratosis Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified health advice, travels to or treatment by using a genuine physician. We are not physicians. Always consult your dr. on Green Tea Extract in Treating Patients With Actinic Keratosis conditions. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. Green Tea Extract in Treating Patients With Actinic Keratosis Clinical research trials and Green Tea Extract in Treating Patients With Actinic Keratosis health trials occur in hundreds of cities throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectivity of new drugs. The propose of the studies / undertakings is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector companies to locate treatments for all sorts of conditions, including Green Tea Extract in Treating Patients With Actinic Keratosis. Green Tea Extract in Treating Patients With Actinic Keratosis Clinical Trials and other clinical trials permit volunteers to acquire medical treatment choices before they are available to the masses. Some times the test subjects obtain professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Green Tea Extract in Treating Patients With Actinic Keratosis clinical trial. Participants oftentimes recieve the most expert healthcare available for their Green Tea Extract in Treating Patients With Actinic Keratosis condition. Hazards are a reality, however, and can include extra or frequent physician visits, health risks (potentially life-endangering), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
|
|
|
|
|
|
|
Home > "G" Clinical Trials Conditions > Green Tea Extract in Treating Patients With Actinic Keratosis  Green Tea Extract in Treating Patients With Actinic Keratosis
Green Tea Extract in Treating Patients With Actinic Keratosis
For Condition: prevention of skin cancer,basal cell carcinoma of the skin,squamous cell carcinoma of the skin,actinic keratosis
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Chao Family Comprehensive Cancer Center
Synopsis: 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.
Details: 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. PROTOCOL 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:
Study Type: Interventional, Prevention
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Clinically and histologically confirmed grade 1-3 actinic keratoses; At least 2 actinic keratoses on each arm --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 --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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
FrankMeyskens, Study Chair, Chao Family Comprehensive Cancer Center
Chao Family Comprehensive Cancer Center
Orange, California, 92868
United States
Additional Information:
Study ID Numbers: CDR0000067798; UCIRVINE-N01-CN-85182,NCI-P00-0142
Study Start Date: March 2000
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005097
Other Prevention Of Skin Cancer Studies:
1. Acitretin in Treating Patients With Skin Disease or Skin Cancer
2. Green Tea Extract in Treating Patients With Actinic Keratosis
3. Celecoxib in Preventing Skin Cancer
4. Topical Imiquimod Compared With Surgery in Treating Patients With Basal Cell Skin Cancer
5. Photodynamic Therapy in Treating Patients With Basal Cell Skin Cancer
Related Studies:
Other prevention of skin cancer Clinical Trials
Other California Clinical Trials
Other Orange Clinical Trials
Green Tea Extract in Treating Patients With Actinic Keratosis
|
|
|
|
|
|
|
|
