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Principal Investigator left institution before study could complete.
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| Name | Class |
|---|---|
| Rutgers University | OTHER |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| active drug | Active Comparator | bilateral comparison of green tea constituent |
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| placebo | Placebo Comparator | bilateral comparison of placebo vehicle |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Green Tea | Drug | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 48 hrs |
| 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. | 48 hr |
| 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. | 48 hr |
| 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. | 48 hr |
| Effect of Topical Applications of 4-6% Caffeine on UVB-Induced Increases in Phospho-p53 (Ser15) Positive Cells |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Melissa Magliocco, MD | Rutgers, The State University of New Jersey | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UMDNJ Division of Clinical Pharmacology | New Brunswick | New Jersey | 08901 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | EGCG in Acetone Vehicle (L Side: Active; R Side: Placebo) | 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. |
| FG001 | EGCG in Acetone Vehicle (R Side: Active; L Side: Placebo) | 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. |
| FG002 | Caffeine in Acetone Vehicle (L Side: Active; R Side: Placebo) | 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. |
| FG003 | Caffeine in Acetone Vehicle (R Side: Active; L Side: Placebo) | 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. |
| FG004 | Caffeine in Cream Vehicle (L Side: Active; R Side: Placebo) | 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. |
| FG005 | Caffeine in Cream Vehicle (R Side: Active; L Side: Placebo) | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Mean | Standard Error | cells/mm | 48 hrs |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 after exposure of the test sites to UVB. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| menstrual cramps | Reproductive system and breast disorders |
Early termination leading to small numbers of subjects analyzed
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr M Magliocco | UMDNJ-Robert Wood Johnson Medical School | maglioma@yahoo.com |
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| ID | Term |
|---|---|
| D013662 | Tea |
| ID | Term |
|---|---|
| D028321 | Plant Preparations |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D001628 | Beverages |
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| Placebo | Drug | 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) |
|
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. |
| 48 hr |
| 48 hrs |
| 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. | 24 hr |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| OG001 | Placebo (Acetone Vehicle in Subjects Who Received EGCG) | 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). |
| OG002 | Caffeine in Acetone Vehicle | 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). |
| OG003 | Placebo (Acetone Vehicle in Subjects Who Received Caffeine) | 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). |
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| 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. | 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. | Posted | Mean | Standard Error | cells/mm | 48 hr |
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| 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. | 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). | Posted | Mean | Standard Error | percentage of "sunburn" cells | 48 hr |
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| 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. | 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). | Posted | Mean | Standard Error | percentage of caspase-3-positive cells | 48 hr |
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| 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. | 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). | Posted | Mean | Standard Error | percentage of p-p53 (Ser15) pos. cells | 48 hr |
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| 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. | 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. | Posted | Mean | Standard Error | units on a scale | 48 hrs |
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| 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. | 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. | Posted | Mean | Standard Error | units on a scale | 24 hr |
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| 0 |
| 68 |
| 6 |
| 68 |
| nausea | Gastrointestinal disorders |
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| tenderness of right test site | Skin and subcutaneous tissue disorders |
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| superficial wound infection | Infections and infestations |
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| headache | Nervous system disorders |
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| tooth abscess | Infections and infestations |
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| accidental removal of a suture | Skin and subcutaneous tissue disorders |
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| rash over adhesive area | Skin and subcutaneous tissue disorders |
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| D000066888 |
| Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |