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This study is designed to determine whether Asians who are especially sensitive to alcohol exposure can be protected by boosting their activities of an alcohol disposing enzyme. This will be accomplished by administering broccoli sprouts that are rich in an agent that increases protective enzyme activity. The test system involves applying alcohol patches to the skin and measuring skin redness.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Broccoli Sprout Extract | Active Comparator | Each subject will act as his/her own control and receive both treatment and placebo on adjacent skin regions. |
|
| Placebo | Placebo Comparator | Each subject will act as his/her own control and receive both treatment and placebo on adjacent skin regions. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Broccoli Sprout Extract | Drug | 150 nanomol of sulforaphane/cm2 of skin in 80% acetone for 3 applications on 3 successive days prior to alcohol challenge |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Area of Skin Erythema (Skin Redness) | For three days in a row, volunteers will receive skin treatments with broccoli sprout extract. On day four, their skin will be measured for a baseline skin color reading. Immediately following this reading, the treated areas of the skin will be challenged with 70 percent alcohol and the redness of the skin will again be measured every 30 minutes for the following two hours for skin color changes. The values were collected every 30 minutes after the alcohol skin challenge for 2 hours and were averaged. Mean and 95% Confidence Interval are reported. | mean up to 2 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins University | Baltimore | Maryland | 21205 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Broccoli Sprout Extract | Each subject will act as his/her own control and receive both treatment and placebo on adjacent skin regions. Broccoli Sprout Extract: 150 nanomol of sulforaphane/cm2 of skin in 80% acetone for 3 applications on 3 successive days prior to alcohol challenge |
| FG001 | Placebo | Each subject will act as his/her own control and receive both treatment and placebo on adjacent skin regions. Placebo: 80% acetone |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Total number of subjects is 30 -- each subject is own control. "Skin area" is the unit of analysis, thus there are both broccoli sprout extract treated and placebo treated skin areas on each subject (totalling 60 skin areas).
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | Total number of subjects is 30. Each subject will act as his/her own control and receive both treatment and placebo on adjacent skin regions. Thus, 60 skin areas will be randomized. Broccoli Sprout Extract: 150 nanomol of sulforaphane/cm2 of skin in 80% acetone for 3 applications on 3 successive days prior to alcohol challenge Placebo Comparator. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Mean Area of Skin Erythema (Skin Redness) | For three days in a row, volunteers will receive skin treatments with broccoli sprout extract. On day four, their skin will be measured for a baseline skin color reading. Immediately following this reading, the treated areas of the skin will be challenged with 70 percent alcohol and the redness of the skin will again be measured every 30 minutes for the following two hours for skin color changes. The values were collected every 30 minutes after the alcohol skin challenge for 2 hours and were averaged. Mean and 95% Confidence Interval are reported. | Since experimental conditions were refined part way through the series and only the last 19 individuals' data was deemed suitable for analysis. | Posted | Mean | 95% Confidence Interval | centimeters^2 | mean up to 2 hours |
|
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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 | Broccoli Sprout Extract | Each subject will act as his/her own control and receive both treatment and placebo on adjacent skin regions. Broccoli Sprout Extract: 150 nanomol of sulforaphane/cm2 of skin in 80% acetone for 3 applications on 3 successive days prior to alcohol challenge |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| mild itchy skin or erythema | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jed W. Fahey, Sc.D. | Johns Hopkins University | 4106142607 | jfahey@jhmi.edu |
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| Placebo | Drug | 80% acetone |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Placebo | Each subject will act as his/her own control and receive both treatment and placebo on adjacent skin regions. Placebo: 80% acetone |
|
|
| 0 |
| 30 |
| 5 |
| 30 |
| EG001 | Placebo | Each subject will act as his/her own control and receive both treatment and placebo on adjacent skin regions. Placebo: 80% acetone | 0 | 30 | 5 | 30 |
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