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Prevention of Alcohol Intolerance

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01845220
Recruitment Status : Completed
First Posted : May 3, 2013
Results First Posted : September 29, 2017
Last Update Posted : September 29, 2017
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins University

Tracking Information
First Submitted Date  ICMJE April 23, 2013
First Posted Date  ICMJE May 3, 2013
Results First Submitted Date  ICMJE July 5, 2017
Results First Posted Date  ICMJE September 29, 2017
Last Update Posted Date September 29, 2017
Study Start Date  ICMJE April 2014
Actual Primary Completion Date July 1, 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 31, 2017)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: May 1, 2013)
Skin Erythema (Skin redness) [ Time Frame: 30 minutes after alcohol skin challenge and every 30 minutes for at least 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.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Prevention of Alcohol Intolerance
Official Title  ICMJE Not Provided
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Alcohol Sensitivity
Intervention  ICMJE
  • 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
  • Drug: Placebo
    80% acetone
Study Arms  ICMJE
  • Active Comparator: Broccoli Sprout Extract
    Each subject will act as his/her own control and receive both treatment and placebo on adjacent skin regions.
    Intervention: Drug: Broccoli Sprout Extract
  • Placebo Comparator: Placebo
    Each subject will act as his/her own control and receive both treatment and placebo on adjacent skin regions.
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 31, 2017)
30
Original Estimated Enrollment  ICMJE
 (submitted: May 1, 2013)
10
Actual Study Completion Date  ICMJE July 1, 2015
Actual Primary Completion Date July 1, 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 18-70 years old,
  • sensitive to alcohol on the skin, Japanese

Exclusion Criteria:

  • recent skin abnormalities /tanning
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01845220
Other Study ID Numbers  ICMJE NA_00081276
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Johns Hopkins University
Study Sponsor  ICMJE Johns Hopkins University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Johns Hopkins University
Verification Date August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP