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

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

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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment
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:	168
Study Start Date:	May 2003
Estimated Study Completion Date:	June 2011
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 0.5-1.5 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 0.5-1.5 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.
Subjects who are unable to get an erythemic response (i.e., a sunburn).

Contacts and Locations

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

Locations

United States, New Jersey
UMDNJ Division of Clinical Pharmacology
New Brunswick, New Jersey, United States, 08901

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

No publications provided

Responsible Party:	Melissa Magliocco, MD, UMDNJ-RWJMS
ClinicalTrials.gov Identifier:	NCT00134381 History of Changes
Other Study ID Numbers:	3808
Study First Received:	August 22, 2005
Last Updated:	January 28, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Medicine and Dentistry New Jersey:

Normal volunteer study

ClinicalTrials.gov processed this record on February 09, 2012