Clinical trial NCT00134381: Green Tea and Ultraviolet Light-induced Skin Damage
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Healthy
Keywords: Normal volunteer study
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
Collaborators: name: Rutgers University
First posted: 2005-08-24
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility 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).

Primary outcomes:
measure: Change in UVB-Induced Active Caspase-3-Positive Keratinocytes by Green Tea Compounds
timeFrame: 48 hrs
measure: Change in UVB-Induced Apoptotic "Sunburn" Cells by Green Tea Compounds
timeFrame: 48 hr
measure: Effect of Topical Applications of 4-6% Caffeine on UVB-Induced Increases in Apoptotic "Sunburn" Cells
timeFrame: 48 hr
measure: Effect of Topical Applications of 4-6% Caffeine on UVB-Induced Increases in Caspase-3-Positive Cells
timeFrame: 48 hr
measure: Effect of Topical Applications of 4-6% Caffeine on UVB-Induced Increases in Phospho-p53 (Ser15) Positive Cells
timeFrame: 48 hr
Secondary outcomes:
measure: Effect of Green Tea Compounds on UVB-Induced Erythema
timeFrame: 48 hrs
measure: Effect of 4-6% Caffeine on UVB-Induced Erythema
timeFrame: 24 hr
Other outcomes:
Locations:
city: New Brunswick
country: United States
facility: UMDNJ Division of Clinical Pharmacology
state: New Jersey
Study officials:
affiliation: Rutgers, The State University of New Jersey
name: Melissa Magliocco, MD
role: PRINCIPAL_INVESTIGATOR
References: