Ignite Creation Date:
2024-05-05 @ 10:05 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00005097
Status:
TERMINATED
Last Update Posted:
2018-04-05
First Post:
2000-04-06
Brief Title:
Green Tea Extract in Treating Patients With Actinic Keratosis
Sponsor:
Frank Meyskens
Organization:
University of California Irvine
Study Overview
Official Title:
A Randomized Double-Blind Placebo-Controlled Phase II Clinical Trial of Polyphenon E Against Various Endpoints of Actinic Keratosis Pathobiology
Status:
TERMINATED
Status Verified Date:
2018-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
terminated due to the low conditional power for a positive study
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
PURPOSE Randomized phase II trial to determine the effectiveness of green tea extract in treating patients who have actinic keratosis
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 patients 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
OUTLINE This is a randomized double blind placebo controlled study One of the patients 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1998-420 | OTHER | University of California Irvine | None |
| UCIRVINE-N01-CN-85182 | OTHER | None | None |
| NCI-P00-0142 | REGISTRY | None | None |
| UCI 98-31 | OTHER | None | None |