Healthy subjects will first be exposed to UV light to determine the minimum dose of UV needed for sunburn ("minimal erythema dose", "MED"). Then, subjects will be exposed to UVB at 1.5x their individual MED (on 2 small areas). Placebo and green tea components will be randomly applied to the 2 sites. Five (5) biopsies will be required to determine the effect of drug on the skin.

Condition	Intervention	Phase
Normal volunteer study	Drug: Green Tea	Phase II

Further Study Details: 

Primary Outcomes: Enhancement of UV-induced p53 and markers of apoptosis by green tea compounds
Secondary Outcomes: Reduction of UV-induced erythema by green tea compounds.
Expected Total Enrollment:  128

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 1-1.5X 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, 8 hours, 24 hours, and 25 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.

Ages Eligible for Study:  18 Years   -   65 Years,  Genders Eligible for Study:  Both

Accepts Healthy Volunteers

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 will be excluded.

Please refer to this study by ClinicalTrials.gov identifier  NCT00134381

New Jersey
      UMDNJ Clinical Research Center, New Brunswick,  New Jersey,  08903,  United States; Recruiting

Study chairs or principal investigators

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

Study ID Numbers:  3808
Last Updated:  August 23, 2005
Record first received:  August 22, 2005
ClinicalTrials.gov Identifier:  NCT00134381
Health Authority: United States: Institutional Review Board
ClinicalTrials.gov processed this record on 2005-08-30