Ignite Creation Date:
2025-12-25 @ 4:14 AM
Ignite Modification Date:
2026-01-29 @ 8:57 AM
Study NCT ID:
NCT01845220
Status:
COMPLETED
Last Update Posted:
2017-09-29
First Post:
2013-04-23
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Prevention of Alcohol Intolerance
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jfahey@jhmi.edu', 'phone': '4106142607', 'title': 'Jed W. Fahey, Sc.D.', 'organization': 'Johns Hopkins University'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Broccoli Sprout Extract', 'description': 'Each subject will act as his/her own control and receive both treatment and placebo on adjacent skin regions.\n\nBroccoli Sprout Extract: 150 nanomol of sulforaphane/cm2 of skin in 80% acetone for 3 applications on 3 successive days prior to alcohol challenge', 'otherNumAtRisk': 30, 'otherNumAffected': 5, 'seriousNumAtRisk': 30, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Each subject will act as his/her own control and receive both treatment and placebo on adjacent skin regions.\n\nPlacebo: 80% acetone', 'otherNumAtRisk': 30, 'otherNumAffected': 5, 'seriousNumAtRisk': 30, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'mild itchy skin or erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean Area of Skin Erythema (Skin Redness)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Broccoli Sprout Extract', 'description': 'Each subject will act as his/her own control and receive both treatment and placebo on adjacent skin regions.\n\nBroccoli Sprout Extract: 150 nanomol of sulforaphane/cm2 of skin in 80% acetone for 3 applications on 3 successive days prior to alcohol challenge'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Each subject will act as his/her own control and receive both treatment and placebo on adjacent skin regions.\n\nPlacebo: 80% acetone'}], 'classes': [{'categories': [{'measurements': [{'value': '3.968', 'groupId': 'OG000', 'lowerLimit': '2.900', 'upperLimit': '5.036'}, {'value': '1.739', 'groupId': 'OG001', 'lowerLimit': '0.912', 'upperLimit': '2.567'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'mean up to 2 hours', 'description': '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.', 'unitOfMeasure': 'centimeters^2', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "Since experimental conditions were refined part way through the series and only the last 19 individuals' data was deemed suitable for analysis."}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Broccoli Sprout Extract', 'description': 'Each subject will act as his/her own control and receive both treatment and placebo on adjacent skin regions.\n\nBroccoli Sprout Extract: 150 nanomol of sulforaphane/cm2 of skin in 80% acetone for 3 applications on 3 successive days prior to alcohol challenge'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Each subject will act as his/her own control and receive both treatment and placebo on adjacent skin regions.\n\nPlacebo: 80% acetone'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numUnits': '30', 'numSubjects': '30'}, {'groupId': 'FG001', 'numUnits': '30', 'numSubjects': '30'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '30', 'numSubjects': '30'}, {'groupId': 'FG001', 'numUnits': '30', 'numSubjects': '30'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG001', 'numUnits': '0', 'numSubjects': '0'}]}]}], 'typeUnitsAnalyzed': 'skin area'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Participants', 'description': '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.\n\nBroccoli 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.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '34', 'groupId': 'BG000', 'lowerLimit': '25', 'upperLimit': '43'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '16', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '14', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '30', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': '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).'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2015-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-08-31', 'studyFirstSubmitDate': '2013-04-23', 'resultsFirstSubmitDate': '2017-07-05', 'studyFirstSubmitQcDate': '2013-05-01', 'lastUpdatePostDateStruct': {'date': '2017-09-29', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-08-31', 'studyFirstPostDateStruct': {'date': '2013-05-03', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-09-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Area of Skin Erythema (Skin Redness)', 'timeFrame': 'mean up to 2 hours', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Broccoli sprouts', 'alcohol sensitivity', 'sulforaphane', 'alcohol metabolism', 'in the Asian Community'], 'conditions': ['Alcohol Sensitivity']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18-70 years old,\n* sensitive to alcohol on the skin, Japanese\n\nExclusion Criteria:\n\n* recent skin abnormalities /tanning'}, 'identificationModule': {'nctId': 'NCT01845220', 'briefTitle': 'Prevention of Alcohol Intolerance', 'organization': {'class': 'OTHER', 'fullName': 'Johns Hopkins University'}, 'orgStudyIdInfo': {'id': 'NA_00081276'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Broccoli Sprout Extract', 'description': 'Each subject will act as his/her own control and receive both treatment and placebo on adjacent skin regions.', 'interventionNames': ['Drug: Broccoli Sprout Extract']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Each subject will act as his/her own control and receive both treatment and placebo on adjacent skin regions.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Broccoli Sprout Extract', 'type': 'DRUG', 'description': '150 nanomol of sulforaphane/cm2 of skin in 80% acetone for 3 applications on 3 successive days prior to alcohol challenge', 'armGroupLabels': ['Broccoli Sprout Extract']}, {'name': 'Placebo', 'type': 'DRUG', 'description': '80% acetone', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21205', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins University', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johns Hopkins University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}