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Green Tea Constituents for UV-Induced Skin Damage

NCT00134381Phase 2

Key facts

Status: Terminated
Start: May 2003
Primary completion: Nov 2012
Countries: 1
Sponsor: Rutgers University
Modality: Classical Binding Small Molecules

Drugs: caffeineepigallocatechin gallate
Conditions: sunburn

Overview

Phase 2, randomised, double-blind trial of caffeine and epigallocatechin gallate in sunburn (2 arms), sponsored by Rutgers University. Primary endpoints: Change in UVB-Induced Active Caspase-3-Positive Keratinocytes by Green Tea Compounds at 48 hours, Change in UVB-Induced Apoptotic 'Sunburn' Cells by Green Tea Compounds at 48 hours and 3 more. Started May 2003; status: terminated.

Design

2 arms

Study design: RandomizedDouble-blind

Active Drug
Topical application of Green Tea constituents (Caffeine or EGCG)
Placebo
Topical application of vehicle

Who it enrols

Healthy adult volunteers aged 18-65 who are able to sunburn and do not consume excessive caffeine.

Endpoints

Primary

Change in UVB-Induced Active Caspase-3-Positive Keratinocytes by Green Tea Compounds48 hours
Change in UVB-Induced Apoptotic 'Sunburn' Cells by Green Tea Compounds48 hours
Effect of Topical Applications of 4-6% Caffeine on UVB-Induced Increases in Apoptotic 'Sunburn' Cells48 hours
Effect of Topical Applications of 4-6% Caffeine on UVB-Induced Increases in Caspase-3-Positive Cells48 hours
Effect of Topical Applications of 4-6% Caffeine on UVB-Induced Increases in Phospho-p53 (Ser15) Positive Cells48 hours

Secondary

Effect of Green Tea Compounds on UVB-Induced Erythema48 hours
Effect of 4-6% Caffeine on UVB-Induced Erythema24 hours

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