NCT00134381

Green Tea and Ultraviolet Light-induced Skin Damage

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 68 (actual)
• Sponsor: Rutgers, The State University of New Jersey · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

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).

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Green Tea	Green tea product (EGCG or caffeine) in vehicle will be applied immediately after and at sequential time points after exposure of a 5x5-cm area of skin to a dose of UVB that is 0.5-2 times the subject's minimal erythema dose (MED)
DRUG	Placebo	Placebo (vehicle alone) will be applied immediately after and at sequential time points after exposure of a 5x5-cm area of skin to a dose of UVB that is 0.5-2 times the subject's minimal erythema dose (MED)

Timeline

• Start date: 2003-05-01
• Primary completion: 2012-11-01
• Completion: 2012-11-01
• First posted: 2005-08-24
• Last updated: 2017-09-06
• Results posted: 2017-09-06

Locations

1 site across 1 country: United States