Healthy
Conditions
Keywords
Normal volunteer study
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.
Interventions
DRUGGreen Tea
Green tea product (EGCG or caffeine) in vehicle will be applied immediately after and at sequential time points after exposure of a 5x5-cm area of skin to a dose of UVB that is 0.5-2 times the subject's minimal erythema dose (MED)
DRUGPlacebo
Placebo (vehicle alone) will be applied immediately after and at sequential time points after exposure of a 5x5-cm area of skin to a dose of UVB that is 0.5-2 times the subject's minimal erythema dose (MED)
Sponsors
Rutgers University
Rutgers, The State University of New Jersey
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in UVB-Induced Apoptotic Sunburn Cells by Green Tea Compounds | 48 hr | 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. |
| Effect of Topical Applications of 4-6% Caffeine on UVB-Induced Increases in Caspase-3-Positive Cells | 48 hr | 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. |
| Effect of Topical Applications of 4-6% Caffeine on UVB-Induced Increases in Phospho-p53 (Ser15) Positive Cells | 48 hr | 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. |
| Change in UVB-Induced Active Caspase-3-Positive Keratinocytes by Green Tea Compounds | 48 hrs | 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. |
| Effect of Topical Applications of 4-6% Caffeine on UVB-Induced Increases in Apoptotic Sunburn Cells | 48 hr | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Effect of 4-6% Caffeine on UVB-Induced Erythema | 24 hr | 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. |
| Effect of Green Tea Compounds on UVB-Induced Erythema | 48 hrs | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Bilateral Comparison 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. | 68 |
| Total | 68 |
Baseline characteristics
| Characteristic | Bilateral Comparison |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 68 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 11 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 57 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 66 Participants |
| Region of Enrollment United States | 68 participants |
| Sex: Female, Male Female | 29 Participants |
| Sex: Female, Male Male | 39 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 6 / 68 |
| serious Total, serious adverse events | 0 / 68 |
Outcome results
Primary
Change in UVB-Induced Active Caspase-3-Positive Keratinocytes by Green Tea Compounds
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
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| EGCG in Acetone Vehicle | Change in UVB-Induced Active Caspase-3-Positive Keratinocytes by Green Tea Compounds | 28.34 cells/mm | Standard Error 18.51 |
| Placebo (Acetone Vehicle in Subjects Who Received EGCG) | Change in UVB-Induced Active Caspase-3-Positive Keratinocytes by Green Tea Compounds | 13.05 cells/mm | Standard Error 9.98 |
| Caffeine in Acetone Vehicle | Change in UVB-Induced Active Caspase-3-Positive Keratinocytes by Green Tea Compounds | 10.68 cells/mm | Standard Error 3.61 |
| Placebo (Acetone Vehicle in Subjects Who Received Caffeine) | Change in UVB-Induced Active Caspase-3-Positive Keratinocytes by Green Tea Compounds | 32.60 cells/mm | Standard Error 28.14 |
Primary
Change in UVB-Induced Apoptotic Sunburn Cells by Green Tea Compounds
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
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| EGCG in Acetone Vehicle | Change in UVB-Induced Apoptotic Sunburn Cells by Green Tea Compounds | 18.94 cells/mm | Standard Error 8.18 |
| Placebo (Acetone Vehicle in Subjects Who Received EGCG) | Change in UVB-Induced Apoptotic Sunburn Cells by Green Tea Compounds | 14.79 cells/mm | Standard Error 7.43 |
| Caffeine in Acetone Vehicle | Change in UVB-Induced Apoptotic Sunburn Cells by Green Tea Compounds | 28.86 cells/mm | Standard Error 8 |
| Placebo (Acetone Vehicle in Subjects Who Received Caffeine) | Change in UVB-Induced Apoptotic Sunburn Cells by Green Tea Compounds | 43.62 cells/mm | Standard Error 29.22 |
Primary
Effect of Topical Applications of 4-6% Caffeine on UVB-Induced Increases in Apoptotic Sunburn Cells
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
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| EGCG in Acetone Vehicle | Effect of Topical Applications of 4-6% Caffeine on UVB-Induced Increases in Apoptotic Sunburn Cells | 7.50 percentage of sunburn cells | Standard Error 2.06 |
| Placebo (Acetone Vehicle in Subjects Who Received EGCG) | Effect of Topical Applications of 4-6% Caffeine on UVB-Induced Increases in Apoptotic Sunburn Cells | 4.93 percentage of sunburn cells | Standard Error 1.54 |
| Caffeine in Acetone Vehicle | Effect of Topical Applications of 4-6% Caffeine on UVB-Induced Increases in Apoptotic Sunburn Cells | 5.10 percentage of sunburn cells | Standard Error 0.8 |
| Placebo (Acetone Vehicle in Subjects Who Received Caffeine) | Effect of Topical Applications of 4-6% Caffeine on UVB-Induced Increases in Apoptotic Sunburn Cells | 4.63 percentage of sunburn cells | Standard Error 0.6 |
Primary
Effect of Topical Applications of 4-6% Caffeine on UVB-Induced Increases in Caspase-3-Positive Cells
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
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| EGCG in Acetone Vehicle | Effect of Topical Applications of 4-6% Caffeine on UVB-Induced Increases in Caspase-3-Positive Cells | 6.54 percentage of caspase-3-positive cells | Standard Error 1.85 |
| Placebo (Acetone Vehicle in Subjects Who Received EGCG) | Effect of Topical Applications of 4-6% Caffeine on UVB-Induced Increases in Caspase-3-Positive Cells | 4.53 percentage of caspase-3-positive cells | Standard Error 1.16 |
| Caffeine in Acetone Vehicle | Effect of Topical Applications of 4-6% Caffeine on UVB-Induced Increases in Caspase-3-Positive Cells | 4.38 percentage of caspase-3-positive cells | Standard Error 0.92 |
| Placebo (Acetone Vehicle in Subjects Who Received Caffeine) | Effect of Topical Applications of 4-6% Caffeine on UVB-Induced Increases in Caspase-3-Positive Cells | 3.15 percentage of caspase-3-positive cells | Standard Error 0.46 |
Primary
Effect of Topical Applications of 4-6% Caffeine on UVB-Induced Increases in Phospho-p53 (Ser15) Positive Cells
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
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| EGCG in Acetone Vehicle | Effect of Topical Applications of 4-6% Caffeine on UVB-Induced Increases in Phospho-p53 (Ser15) Positive Cells | 13.03 percentage of p-p53 (Ser15) pos. cells | Standard Error 2.4 |
| Placebo (Acetone Vehicle in Subjects Who Received EGCG) | Effect of Topical Applications of 4-6% Caffeine on UVB-Induced Increases in Phospho-p53 (Ser15) Positive Cells | 13.46 percentage of p-p53 (Ser15) pos. cells | Standard Error 2.47 |
| Caffeine in Acetone Vehicle | Effect of Topical Applications of 4-6% Caffeine on UVB-Induced Increases in Phospho-p53 (Ser15) Positive Cells | 15.98 percentage of p-p53 (Ser15) pos. cells | Standard Error 2.17 |
| Placebo (Acetone Vehicle in Subjects Who Received Caffeine) | Effect of Topical Applications of 4-6% Caffeine on UVB-Induced Increases in Phospho-p53 (Ser15) Positive Cells | 15.15 percentage of p-p53 (Ser15) pos. cells | Standard Error 2.57 |
Secondary
Effect of 4-6% Caffeine on UVB-Induced Erythema
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
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| EGCG in Acetone Vehicle | Effect of 4-6% Caffeine on UVB-Induced Erythema | 0.18 units on a scale | Standard Error 0.04 |
| Placebo (Acetone Vehicle in Subjects Who Received EGCG) | Effect of 4-6% Caffeine on UVB-Induced Erythema | 0.38 units on a scale | Standard Error 0.05 |
| Caffeine in Acetone Vehicle | Effect of 4-6% Caffeine on UVB-Induced Erythema | 0.66 units on a scale | Standard Error 0.06 |
| Placebo (Acetone Vehicle in Subjects Who Received Caffeine) | Effect of 4-6% Caffeine on UVB-Induced Erythema | 0.83 units on a scale | Standard Error 0.05 |
| Caffeine in Vehicle Cream (1.5 MED Group) | Effect of 4-6% Caffeine on UVB-Induced Erythema | 1.14 units on a scale | Standard Error 0.05 |
| Placebo Cream (1.5 MED Group) | Effect of 4-6% Caffeine on UVB-Induced Erythema | 1.36 units on a scale | Standard Error 0.05 |
Secondary
Effect of Green Tea Compounds on UVB-Induced Erythema
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
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| EGCG in Acetone Vehicle | Effect of Green Tea Compounds on UVB-Induced Erythema | 1.33 units on a scale | Standard Error 0.44 |
| Placebo (Acetone Vehicle in Subjects Who Received EGCG) | Effect of Green Tea Compounds on UVB-Induced Erythema | 1 units on a scale | Standard Error 0 |
| Caffeine in Acetone Vehicle | Effect of Green Tea Compounds on UVB-Induced Erythema | 1.17 units on a scale | Standard Error 0.17 |
| Placebo (Acetone Vehicle in Subjects Who Received Caffeine) | Effect of Green Tea Compounds on UVB-Induced Erythema | 1.33 units on a scale | Standard Error 0.44 |