Green Tea and Ultraviolet Light-Induced Skin Damage - Full Text View

Purpose

The purpose of this study is to investigate whether topically applied constituents of green tea [caffeine or (-)-epigallocatechin gallate; EGCG] have a protective effect on skin exposed to ultraviolet light (UV).

Condition	Intervention	Phase
Healthy	Drug: Green Tea	Phase II

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study

Official Title:	The Effects of Topically Applied Constituents of Green Tea on UV Induced Increase in p53 and Apoptotic Markers in the Skin of Human Volunteers

Further study details as provided by University of Medicine and Dentistry New Jersey:

Primary Outcome Measures:

Enhancement of UV-induced p53 and markers of apoptosis by green tea compounds [ Time Frame: 48 hrs ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Reduction of UV-induced erythema by green tea compounds [ Time Frame: 48 hrs ] [ Designated as safety issue: No ]

Estimated Enrollment:	128
Study Start Date:	May 2003
Estimated Study Completion Date:	May 2007
Estimated Primary Completion Date:	June 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1 bilateral comparison of green tea constituent vs. placebo	Drug: Green Tea green tea product and placebo will be applied in cream formulation immediately after and at 1/2 hour, 1 hour, 2 hours, 4 hours, 6 hours, 8 hours, 24 hours, 25 hours, and 27 hours after exposure to a 1-1.5 MED dose of UV light

Detailed Description:

The purpose of this study is to investigate if topically applied constituents of green tea [caffeine or (-) - epigallocatechin gallate; EGCG] have a protective effect on skin exposed to ultraviolet light (UV). In the double-blinded study all subjects will receive 311 nanometer UVB light at a dose that is 0.5-1.5X their individual minimal erythema dose (MED). One part of the experiment will involve applying a topical natural product (caffeine or EGCG) and placebo to bilateral symmetric sites. The natural product and the placebo will be applied immediately after and at 1/2 hour, 1 hour, 2 hours, 4 hours, 6 hours, 8 hours, 24 hours, 25 hours, and 27 hours after exposure to a 1-1.5 MED dose of UV light. Another part of the study involves performing skin biopsies. One will be done prior to UVB exposure, 2 will be done at 24 hours and 2 more will be done at 48 hours.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

The subjects will be normal adult volunteers who are 18 to 65 years of age.

Exclusion Criteria:

Subjects who drink more than two cups of coffee, tea, or caffeinated soda/beverages per day.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00134381

Locations


United States, New Jersey
	UMDNJ Division of Clinical Pharmacology	Recruiting
	New Brunswick, New Jersey, United States, 08901
	Contact: Patricia Hanas 732-235-8063 hanaspw@umdnj.edu

Sponsors and Collaborators

University of Medicine and Dentistry New Jersey

Rutgers University

Investigators


Principal Investigator:	Melissa Magliocco, MD	University of Medicine and Dentistry New Jersey

More Information

Responsible Party:	UMDNJ-RWJMS ( Melissa Magliocco, MD )
Study ID Numbers:	3808
First Received:	August 22, 2005
Last Updated:	February 13, 2008
ClinicalTrials.gov Identifier:	NCT00134381
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Medicine and Dentistry New Jersey:

Normal volunteer study

Study placed in the following topic categories:

Healthy

ClinicalTrials.gov processed this record on October 17, 2008

Sponsors and Collaborators:	University of Medicine and Dentistry New Jersey Rutgers University
Information provided by:	University of Medicine and Dentistry New Jersey
ClinicalTrials.gov Identifier:	NCT00134381