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Green Tea and Ultraviolet Light-induced Skin Damage

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ClinicalTrials.gov Identifier: NCT00134381
Recruitment Status : Terminated (Principal Investigator left institution before study could complete.)
First Posted : August 24, 2005
Results First Posted : September 6, 2017
Last Update Posted : September 6, 2017
Sponsor:
Collaborator:
Rutgers University
Information provided by (Responsible Party):
Rutgers, The State University of New Jersey

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Healthy
Interventions Drug: Green Tea
Drug: Placebo
Enrollment 68
Recruitment Details  
Pre-assignment Details  
Arm/Group Title EGCG in Acetone Vehicle (L Side: Active; R Side: Placebo) EGCG in Acetone Vehicle (R Side: Active; L Side: Placebo) Caffeine in Acetone Vehicle (L Side: Active; R Side: Placebo) Caffeine in Acetone Vehicle (R Side: Active; L Side: Placebo) Caffeine in Cream Vehicle (L Side: Active; R Side: Placebo) Caffeine in Cream Vehicle (R Side: Active; L Side: Placebo)
Hide Arm/Group Description bilateral comparison Subjects randomized to this group received applications of EGCG to a test site on the left side of the body and placebo to a test site on the right side of the body. bilateral comparison Subjects randomized to this group received applications of EGCG to a test site on the right side of the body and placebo to a test site on the left side of the body. bilateral comparison Subjects randomized to this group received applications of caffeine to a test site on the left side of the body and placebo to a test site on the right side of the body. bilateral comparison Subjects randomized to this group received applications of caffeine to a test site on the right side of the body and placebo to a test site on the left side of the body. bilateral comparison Subjects randomized to this group received applications of caffeine to a test site on the left side of the body and placebo to a test site on the right side of the body. bilateral comparison Subjects randomized to this group received applications of caffeine to a test site on the right side of the body and placebo to a test site on the left side of the body.
Period Title: Overall Study
Started 1 2 1 2 31 31
Completed 1 2 1 2 31 29
Not Completed 0 0 0 0 0 2
Arm/Group Title Bilateral Comparison
Hide Arm/Group Description In this bilateral comparison study, subjects were randomized to receive applications of green tea product or placebo to test sites on the left and right sides of the body.
Overall Number of Baseline Participants 68
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 68 participants
<=18 years
0
   0.0%
Between 18 and 65 years
68
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 68 participants
Female
29
  42.6%
Male
39
  57.4%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 68 participants
Hispanic or Latino
11
  16.2%
Not Hispanic or Latino
57
  83.8%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 68 participants
American Indian or Alaska Native
0
   0.0%
Asian
1
   1.5%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
1
   1.5%
White
66
  97.1%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 68 participants
68
1.Primary Outcome
Title Change in UVB-Induced Active Caspase-3-Positive Keratinocytes by Green Tea Compounds
Hide Description The mean change in number of active caspase-3+ apoptotic keratinocytes between 0- and 48-hour time points was calculated for skin biopsy samples of subjects who had been exposed to UVB on symmetrical right and left test sites which were then randomized to receive active test substance (EGCG or caffeine) or placebo (vehicle) at sequential time points after UVB exposure.
Time Frame 48 hrs
Hide Outcome Measure Data
Hide Analysis Population Description
Six (6) subjects were randomized (split-body) to receive either EGCG (3 subjects) or caffeine (3 subjects) in acetone vehicle on a test site on one side of the body and placebo (acetone vehicle) on the test site on the other side of the body, after exposure to twice the individual subjects' minimal erythema dose (MED) of UVB.
Arm/Group Title EGCG in Acetone Vehicle Placebo (Acetone Vehicle in Subjects Who Received EGCG) Caffeine in Acetone Vehicle Placebo (Acetone Vehicle in Subjects Who Received Caffeine)
Hide Arm/Group Description:
bilateral comparison Subjects were randomized to receive applications of EGCG (28.3 mg/mL; active drug) on the test site on one side of the body after exposure to UVB that was twice their individual minimal erythema dose (MED).
bilateral comparison Subjects were randomized to receive applications of acetone vehicle (placebo) on the test site on one side of the body after exposure to UVB that was twice their individual minimal erythema dose (MED).
bilateral comparison Subjects were randomized to receive applications of caffeine (12 mg/mL; active drug) on the test site on one side of the body after exposure to UVB that was twice their individual minimal erythema dose (MED).
bilateral comparison Subjects were randomized to receive applications of acetone vehicle (placebo) on the test site on one side of the body after exposure to UVB that was twice their individual minimal erythema dose (MED).
Overall Number of Participants Analyzed 3 3 3 3
Mean (Standard Error)
Unit of Measure: cells/mm
28.34  (18.51) 13.05  (9.98) 10.68  (3.61) 32.60  (28.14)
2.Primary Outcome
Title Change in UVB-Induced Apoptotic "Sunburn" Cells by Green Tea Compounds
Hide Description The mean change in number of apoptotic "sunburn" cells between 0- and 48-hour time points was calculated for skin biopsy samples of subjects who had been exposed to UVB on symmetrical right and left test sites which were then randomized to receive active test substance (EGCG or caffeine) or placebo (vehicle) at sequential time points after UVB exposure.
Time Frame 48 hr
Hide Outcome Measure Data
Hide Analysis Population Description
Six (6) subjects were randomized (split-body) to receive either EGCG (3 subjects) or caffeine (3 subjects) in acetone vehicle on a test site on one side of the body and placebo (acetone vehicle) on the test site on the other side of the body, after exposure to twice the individual subjects' minimal erythema dose (MED) of UVB.
Arm/Group Title EGCG in Acetone Vehicle Placebo (Acetone Vehicle in Subjects Who Received EGCG) Caffeine in Acetone Vehicle Placebo (Acetone Vehicle in Subjects Who Received Caffeine)
Hide Arm/Group Description:
bilateral comparison Subjects were randomized to receive applications of EGCG (28.3 mg/mL; active drug) on the test site on one side of the body after exposure to UVB that was twice their individual minimal erythema dose (MED).
bilateral comparison Subjects were randomized to receive applications of acetone vehicle (placebo) on the test site on one side of the body after exposure to UVB that was twice their individual minimal erythema dose (MED).
bilateral comparison Subjects were randomized to receive applications of caffeine (12 mg/mL; active drug) on the test site on one side of the body after exposure to UVB that was twice their individual minimal erythema dose (MED).
bilateral comparison Subjects were randomized to receive applications of acetone vehicle (placebo) on the test site on one side of the body after exposure to UVB that was twice their individual minimal erythema dose (MED).
Overall Number of Participants Analyzed 3 3 3 3
Mean (Standard Error)
Unit of Measure: cells/mm
18.94  (8.18) 14.79  (7.43) 28.86  (8.00) 43.62  (29.22)
3.Primary Outcome
Title Effect of Topical Applications of 4-6% Caffeine on UVB-Induced Increases in Apoptotic "Sunburn" Cells
Hide Description The percentage of apoptotic "sunburn" cells was identified in the 48-hr time point skin biopsy samples of subjects who had been exposed to UVB on symmetrical right and left test sites which were then randomized to receive 4-6% caffeine in cream vehicle or placebo (cream vehicle) at sequential time points after UVB exposure.
Time Frame 48 hr
Hide Outcome Measure Data
Hide Analysis Population Description
Twenty (20) subjects received caffeine on one test site and placebo on the other site after exposure to individual subjects' minimal erythema dose (MED) of UVB.Twenty-six (26) subjects received caffeine on one test site and placebo on the other site after exposure to UVB that was 1.5 times subjects' individual minimal erythema dose (MED).
Arm/Group Title Caffeine in Vehicle Cream (1.0 MED Group) Placebo Cream (1.0 MED Group) Caffeine in Vehicle Cream (1.5 MED Group) Placebo Cream (1.5 MED Group)
Hide Arm/Group Description:
bilateral comparison Subjects were randomized to receive applications of 6% caffeine (active drug) on the test site on one side of the body after exposure to UVB at the subjects' individual minimal erythema dose (MED).
bilateral comparison Subjects were randomized to receive applications of cream vehicle (placebo) on the test site on one side of the body after exposure to UVB at the subjects' individual minimal erythema dose (MED).
bilateral comparison Subjects were randomized to receive applications of 4-6% caffeine (active drug) on the test site on one side of the body after exposure to UVB that was 1.5 times subjects' individual minimal erythema dose (MED).
bilateral comparison Subjects were randomized to receive applications of cream vehicle (placebo) on the test site on one side of the body after exposure to UVB that was 1.5 times subjects' individual minimal erythema dose (MED).
Overall Number of Participants Analyzed 20 20 26 26
Mean (Standard Error)
Unit of Measure: percentage of "sunburn" cells
7.50  (2.06) 4.93  (1.54) 5.10  (0.80) 4.63  (0.60)
4.Primary Outcome
Title Effect of Topical Applications of 4-6% Caffeine on UVB-Induced Increases in Caspase-3-Positive Cells
Hide Description The percentage of caspase-3-positive cells was identified in the 48-hr time point skin biopsy samples of subjects who had been exposed to UVB on symmetrical right and left test sites which were then randomized to receive 4-6% caffeine in cream vehicle or placebo (cream vehicle) at sequential time points after UVB exposure.
Time Frame 48 hr
Hide Outcome Measure Data
Hide Analysis Population Description
Twenty (20) subjects received caffeine on one test site and placebo on the other site after exposure to individual subjects' minimal erythema dose (MED) of UVB.Twenty-six (26) subjects received caffeine on one test site and placebo on the other site after exposure to UVB that was 1.5 times subjects' individual minimal erythema dose (MED).
Arm/Group Title Caffeine in Vehicle Cream (1.0 MED Group) Placebo Cream (1.0 MED Group) Caffeine in Vehicle Cream (1.5 MED Group) Placebo Cream (1.5 MED Group)
Hide Arm/Group Description:
bilateral comparison Subjects were randomized to receive applications of 6% caffeine (active drug) on the test site on one side of the body after exposure to UVB at the subjects' individual minimal erythema dose (MED).
bilateral comparison Subjects were randomized to receive applications of cream vehicle (placebo) on the test site on one side of the body after exposure to UVB at the subjects' individual minimal erythema dose (MED).
bilateral comparison Subjects were randomized to receive applications of 4-6% caffeine (active drug) on the test site on one side of the body after exposure to UVB that was 1.5 times subjects' individual minimal erythema dose (MED).
bilateral comparison Subjects were randomized to receive applications of cream vehicle (placebo) on the test site on one side of the body after exposure to UVB that was 1.5 times subjects' individual minimal erythema dose (MED).
Overall Number of Participants Analyzed 20 20 26 26
Mean (Standard Error)
Unit of Measure: percentage of caspase-3-positive cells
6.54  (1.85) 4.53  (1.16) 4.38  (0.92) 3.15  (0.46)
5.Primary Outcome
Title Effect of Topical Applications of 4-6% Caffeine on UVB-Induced Increases in Phospho-p53 (Ser15) Positive Cells
Hide Description The percentage of phospho-p53 (Ser15) positive cells was identified in the 48-hr time point skin biopsy samples of subjects who had been exposed to UVB on symmetrical right and left test sites which were then randomized to receive 4-6% caffeine in cream vehicle or placebo (cream vehicle) at sequential time points after UVB exposure.
Time Frame 48 hr
Hide Outcome Measure Data
Hide Analysis Population Description
Twenty (20) subjects received caffeine on one test site and placebo on the other site after exposure to individual subjects' minimal erythema dose (MED) of UVB.Twenty-six (26) subjects received caffeine on one test site and placebo on the other site after exposure to UVB that was 1.5 times subjects' individual minimal erythema dose (MED).
Arm/Group Title Caffeine in Vehicle Cream (1.0 MED Group) Placebo Cream (1.0 MED Group) Caffeine in Vehicle Cream (1.5 MED Group) Placebo Cream (1.5 MED Group)
Hide Arm/Group Description:
bilateral comparison Subjects were randomized to receive applications of 6% caffeine (active drug) on the test site on one side of the body after exposure to UVB at the subjects' individual minimal erythema dose (MED).
bilateral comparison Subjects were randomized to receive applications of cream vehicle (placebo) on the test site on one side of the body after exposure to UVB at the subjects' individual minimal erythema dose (MED).
bilateral comparison Subjects were randomized to receive applications of 4-6% caffeine (active drug) on the test site on one side of the body after exposure to UVB that was 1.5 times subjects' individual minimal erythema dose (MED).
bilateral comparison Subjects were randomized to receive applications of cream vehicle (placebo) on the test site on one side of the body after exposure to UVB that was 1.5 times subjects' individual minimal erythema dose (MED).
Overall Number of Participants Analyzed 20 20 26 26
Mean (Standard Error)
Unit of Measure: percentage of p-p53 (Ser15) pos. cells
13.03  (2.40) 13.46  (2.47) 15.98  (2.17) 15.15  (2.57)
6.Secondary Outcome
Title Effect of Green Tea Compounds on UVB-Induced Erythema
Hide Description Erythema of the right and left test sites was scored on a scale of 0-3 (0 = no evidence [no erythema]; 1 = mild [pink or light red color]; 2 = moderate [red color]; 3 = severe [very red or dark color]) including half-integer grading. Scoring was performed immediately after UVB exposure and at sequential time points thereafter. The mean scores at 48 hr were calculated.
Time Frame 48 hrs
Hide Outcome Measure Data
Hide Analysis Population Description
Six (6) subjects were randomized (split-body) to receive either EGCG (3 subjects) or caffeine (3 subjects) in acetone vehicle on a test site on one side of the body and placebo (acetone vehicle) on the test site on the other side of the body, after exposure to twice the individual subjects' minimal erythema dose (MED) of UVB.
Arm/Group Title EGCG in Acetone Vehicle Placebo (Acetone Vehicle in Subjects Who Received EGCG) Caffeine in Acetone Vehicle Placebo (Acetone Vehicle in Subjects Who Received Caffeine)
Hide Arm/Group Description:
bilateral comparison Subjects were randomized to receive applications of EGCG (28.3 mg/mL; active drug) on the test site on one side of the body after exposure to UVB that was twice their individual minimal erythema dose (MED).
bilateral comparison Subjects were randomized to receive applications of acetone vehicle (placebo) on the test site on one side of the body after exposure to UVB that was twice their individual minimal erythema dose (MED).
bilateral comparison Subjects were randomized to receive applications of caffeine (12 mg/mL; active drug) on the test site on one side of the body after exposure to UVB that was twice their individual minimal erythema dose (MED).
bilateral comparison Subjects were randomized to receive applications of acetone vehicle (placebo) on the test site on one side of the body after exposure to UVB that was twice their individual minimal erythema dose (MED).
Overall Number of Participants Analyzed 3 3 3 3
Mean (Standard Error)
Unit of Measure: units on a scale
1.33  (0.44) 1  (0) 1.17  (0.17) 1.33  (0.44)
7.Secondary Outcome
Title Effect of 4-6% Caffeine on UVB-Induced Erythema
Hide Description Erythema of the right and left test sites was scored on a scale of 0-3 (0 = no evidence [no erythema]; 1 = mild [pink or light red color]; 2 = moderate [red color]; 3 = severe [very red or dark color]) including half-integer grading. Scoring was performed immediately after UVB exposure and at sequential time points thereafter. The erythema scores at 6, 8, and 24 hr post-UVB were averaged.
Time Frame 24 hr
Hide Outcome Measure Data
Hide Analysis Population Description
Sixty-two (62) subjects received caffeine on one test site and placebo on the other site after exposure to 0.5-1.5 times individual subjects' minimal erythema dose (MED) of UVB.
Arm/Group Title Caffeine in Vehicle Cream (0.5 MED Group) Placebo Cream (0.5 MED Group) Caffeine in Vehicle Cream (1.0 MED Group) Placebo Cream (1.0 MED Group) Caffeine in Vehicle Cream (1.5 MED Group) Placebo Cream (1.5 MED Group)
Hide Arm/Group Description:
bilateral comparison Subjects were randomized to receive applications of 6% caffeine (active drug) on the test site on one side of the body after exposure to UVB at 0.5 times the subjects' individual minimal erythema dose (MED).
bilateral comparison Subjects were randomized to receive applications of cream vehicle (placebo) on the test site on one side of the body after exposure to UVB at 0.5 times the subjects' individual minimal erythema dose (MED).
bilateral comparison Subjects were randomized to receive applications of 6% caffeine (active drug) on the test site on one side of the body after exposure to UVB at the subjects' individual minimal erythema dose (MED).
bilateral comparison Subjects were randomized to receive applications of cream vehicle (placebo) on the test site on one side of the body after exposure to UVB at the subjects' individual minimal erythema dose (MED).
bilateral comparison Subjects were randomized to receive applications of 4-6% caffeine (active drug) on the test site on one side of the body after exposure to UVB that was 1.5 times subjects' individual minimal erythema dose (MED).
bilateral comparison Subjects were randomized to receive applications of cream vehicle (placebo) on the test site on one side of the body after exposure to UVB that was 1.5 times subjects' individual minimal erythema dose (MED).
Overall Number of Participants Analyzed 12 12 21 21 29 29
Mean (Standard Error)
Unit of Measure: units on a scale
0.18  (0.04) 0.38  (0.05) 0.66  (0.06) 0.83  (0.05) 1.14  (0.05) 1.36  (0.05)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Bilateral Comparison
Hide Arm/Group Description In this bilateral comparison study, subjects were randomized to receive applications of green tea product or placebo to test sites on the left and right sides of the body after exposure of the test sites to UVB.
All-Cause Mortality
Bilateral Comparison
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Bilateral Comparison
Affected / at Risk (%) # Events
Total   0/68 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Bilateral Comparison
Affected / at Risk (%) # Events
Total   6/68 (8.82%)    
Gastrointestinal disorders   
nausea  1/68 (1.47%)  1
Infections and infestations   
superficial wound infection  1/68 (1.47%)  1
tooth abscess  1/68 (1.47%)  1
Nervous system disorders   
headache  1/68 (1.47%)  1
Reproductive system and breast disorders   
menstrual cramps  1/68 (1.47%)  1
Skin and subcutaneous tissue disorders   
tenderness of right test site  1/68 (1.47%)  1
accidental removal of a suture  1/68 (1.47%)  1
rash over adhesive area  1/68 (1.47%)  1
Early termination leading to small numbers of subjects analyzed
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr M Magliocco
Organization: UMDNJ-Robert Wood Johnson Medical School
Responsible Party: Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier: NCT00134381     History of Changes
Other Study ID Numbers: 3808
First Submitted: August 22, 2005
First Posted: August 24, 2005
Results First Submitted: April 11, 2017
Results First Posted: September 6, 2017
Last Update Posted: September 6, 2017