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Green Tea and Ultraviolet Light-induced Skin Damage

Rutgers The State University of New Jersey logo

Rutgers The State University of New Jersey

Status and phase

Terminated
Phase 2

Conditions

Healthy

Treatments

Drug: Placebo
Drug: Green Tea

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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).

Full 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.

Enrollment

68 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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).

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

68 participants in 2 patient groups, including a placebo group

active drug
Active Comparator group
Description:
bilateral comparison of green tea constituent
Treatment:
Drug: Green Tea
placebo
Placebo Comparator group
Description:
bilateral comparison of placebo vehicle
Treatment:
Drug: Placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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