Prevention of Alcohol Intolerance
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ClinicalTrials.gov Identifier: NCT01845220 |
Recruitment Status :
Completed
First Posted : May 3, 2013
Results First Posted : September 29, 2017
Last Update Posted : September 29, 2017
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Condition or disease | Intervention/treatment | Phase |
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Alcohol Sensitivity | Drug: Broccoli Sprout Extract Drug: Placebo | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 30 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | Double (Participant, Outcomes Assessor) |
Primary Purpose: | Prevention |
Study Start Date : | April 2014 |
Actual Primary Completion Date : | July 1, 2015 |
Actual Study Completion Date : | July 1, 2015 |
Arm | Intervention/treatment |
---|---|
Active Comparator: Broccoli Sprout Extract
Each subject will act as his/her own control and receive both treatment and placebo on adjacent skin regions.
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Drug: 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: Placebo
Each subject will act as his/her own control and receive both treatment and placebo on adjacent skin regions.
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Drug: Placebo
80% acetone |
- Mean Area of Skin Erythema (Skin Redness) [ Time Frame: mean up to 2 hours ]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.

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Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- 18-70 years old,
- sensitive to alcohol on the skin, Japanese
Exclusion Criteria:
- recent skin abnormalities /tanning

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01845220
United States, Maryland | |
Johns Hopkins University | |
Baltimore, Maryland, United States, 21205 |
Responsible Party: | Johns Hopkins University |
ClinicalTrials.gov Identifier: | NCT01845220 |
Other Study ID Numbers: |
NA_00081276 |
First Posted: | May 3, 2013 Key Record Dates |
Results First Posted: | September 29, 2017 |
Last Update Posted: | September 29, 2017 |
Last Verified: | August 2017 |
Broccoli sprouts alcohol sensitivity sulforaphane alcohol metabolism in the Asian Community |
Hypersensitivity Immune System Diseases |