Non-melanomatous Skin Cancer Clinical Trial
Official title:
A Randomized, Double-Blind, Placebo-Controlled Phase II Clinical Trial of Polyphenon E Against Various Endpoints of Actinic Keratosis Pathobiology
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.
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.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT00423397 -
Gefitinib and PEG-Interferon Alfa-2a in Treating Patients With Unresectable or Metastatic Skin Cancer
|
Phase 1/Phase 2 | |
| Completed |
NCT00103246 -
Photodynamic Therapy Using Silicon Phthalocyanine 4 in Treating Patients With Actinic Keratosis, Bowen's Disease, Skin Cancer, or Stage I or Stage II Mycosis Fungoides
|
Phase 1 | |
| Active, not recruiting |
NCT00391300 -
Bioelectric Field Imaging in Diagnosing Melanoma and Other Skin Cancers in Patients With Skin Lesions
|
Phase 1 | |
| Completed |
NCT00066872 -
Topical Imiquimod Compared With Surgery in Treating Patients With Basal Cell Skin Cancer
|
Phase 3 | |
| Completed |
NCT00002963 -
Photodynamic Therapy in Treating Patients With Skin Cancer
|
Phase 2 | |
| Completed |
NCT00021294 -
Eflornithine With or Without Triamcinolone in Preventing Nonmelanoma Skin Cancer in Patients With Actinic Keratosis
|
Phase 2 | |
| Completed |
NCT00003611 -
Acitretin in Preventing Skin Cancers in Patients With Previously Treated Skin Cancers Who Have Undergone Organ Transplantation
|
N/A | |
| Terminated |
NCT00663910 -
Topical Aminolevulinic Acid in Patients With Nonmelanoma Skin Cancer
|
Phase 0 | |
| Recruiting |
NCT00295906 -
Computer-Based Continuing Education for Doctors in Examination and Counseling of Patients on Skin Cancer or Weight Control
|
N/A | |
| Completed |
NCT00025012 -
Isotretinoin in Preventing Skin Cancer
|
N/A | |
| Completed |
NCT00021125 -
Radiation Therapy in Treating Patients With Head and Neck Cancer
|
Phase 3 | |
| Completed |
NCT00601640 -
Eflornithine and/or Diclofenac in Treating Patients With Sun-Damaged Skin
|
Phase 2 | |
| Completed |
NCT00079300 -
Imiquimod Cream in Treating Patients With Basal Cell Skin Cancer
|
Phase 1 | |
| Completed |
NCT00017485 -
Photodynamic Therapy in Treating Patients With Basal Cell Skin Cancer
|
Phase 1 | |
| Recruiting |
NCT00747903 -
Photodynamic Therapy Using Aminolevulinic Acid in Treating Patients With Skin Cancer
|
Phase 2 | |
| Terminated |
NCT00899132 -
Studying a Tumor Marker for Testicular Cancer, Skin Cancer, Small Intestine Cancer, and Pancreatic Cancer
|
N/A | |
| Completed |
NCT00099112 -
Effect of Solar-Simulated Ultraviolet Radiation on Gene Expression in Unprotected and Sunscreen-Protected Skin of Healthy Adults With Fitzpatrick Skin Type II
|
N/A | |
| Completed |
NCT00644384 -
Acitretin in Preventing Skin Cancer in Patients at High Risk for Skin Cancer
|
N/A | |
| Completed |
NCT00023621 -
Celecoxib in Preventing Basal Cell Carcinoma in Patients With Basal Cell Nevus Syndrome
|
Phase 2 | |
| Completed |
NCT00002975 -
Photodynamic Therapy in Treating Patients With Skin Cancer
|
Phase 2 |