Green Tea and Ultraviolet Light-induced Skin Damage

Healthy Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00134381
• Other study ID #: 3808
• Status: Terminated
• Phase: Phase 2
• First received: August 22, 2005
• Last updated: February 2, 2015
• Start date: May 2003
• Est. completion date: November 2012

Study information

• Verified date: February 2015
• Source: Rutgers, The State University of New Jersey
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 80
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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).

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy

Intervention

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

Locations

Country	Name	City	State
United States	UMDNJ Division of Clinical Pharmacology	New Brunswick	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
Rutgers, The State University of New Jersey	Rutgers University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Enhancement of UV-induced p53 and markers of apoptosis by green tea compounds		48 hrs	No
Secondary	Reduction of UV-induced erythema by green tea compounds		48 hrs	No