Ignite Creation Date:
2025-12-24 @ 12:41 PM
Ignite Modification Date:
2026-02-22 @ 7:03 AM
Study NCT ID:
NCT02944461
Status:
COMPLETED
Last Update Posted:
2019-04-03
First Post:
2016-10-04
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy and Safety of Aczone 7.5% Gel in the Treatment of Truncal Acne Vulgaris
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000152', 'term': 'Acne Vulgaris'}], 'ancestors': [{'id': 'D017486', 'term': 'Acneiform Eruptions'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D012625', 'term': 'Sebaceous Gland Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003622', 'term': 'Dapsone'}, {'id': 'D005782', 'term': 'Gels'}], 'ancestors': [{'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D003102', 'term': 'Colloids'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D004304', 'term': 'Dosage Forms'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mmdermresearch@yahoo.com', 'phone': '5024519000', 'title': 'M. McAllister', 'organization': 'Skin Sciences, PLLC'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '16 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Dapsone Gel 7.5%', 'description': 'Dapsone gel 7.5% to be applied to truncal acne once daily for 16 weeks.\n\nDapsone 7.5 % gel: Dapsone gel 7.5% applied once daily to truncal acne', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 3, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'infected abrasions of legs', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'gum graft surgery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'stye, right eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'sunburn arms/chest/back', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percent of Subjects Who Achieve at Least a Two Grade Improvement and a Rating of Clear or Almost Clear on the Investigator Global Assessment (IGA) Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Dapsone Gel 7.5%', 'description': 'Dapsone gel 7.5% to be applied to truncal acne once daily for 16 weeks.\n\nDapsone 7.5 % gel: Dapsone gel 7.5% applied once daily to truncal acne'}], 'classes': [{'title': 'week 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'week 10', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'week 16', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '16 weeks', 'description': 'Investigator will evaluate global acne severity using the IGA scale as follows: 1= Clear Skin, 2 = Almost Clear, 3 = Mild Severity, 4 = Severe, 5 = Very Severe', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'The Percent Change in Inflammatory Lesion Count at Week 16 Compared to Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Dapsone Gel 7.5%', 'description': 'Dapsone gel 7.5% to be applied to truncal acne once daily for 16 weeks.\n\nDapsone 7.5 % gel: Dapsone gel 7.5% applied once daily to truncal acne'}], 'classes': [{'categories': [{'measurements': [{'value': '-74', 'spread': '21', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '16 Weeks', 'unitOfMeasure': 'percent change in lesion count', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'The Percent Change in Non-inflammatory Lesion Count at Week 16 Compared to Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Dapsone Gel 7.5%', 'description': 'Dapsone gel 7.5% to be applied to truncal acne once daily for 16 weeks.\n\nDapsone 7.5 % gel: Dapsone gel 7.5% applied once daily to truncal acne'}], 'classes': [{'categories': [{'measurements': [{'value': '-72', 'spread': '28', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '16 Weeks', 'unitOfMeasure': 'percent change in lesion count', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'The Percent Change in Total Lesion Count at Week 16 Compared to Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Dapsone Gel 7.5%', 'description': 'Dapsone gel 7.5% to be applied to truncal acne once daily for 16 weeks.\n\nDapsone 7.5 % gel: Dapsone gel 7.5% applied once daily to truncal acne'}], 'classes': [{'categories': [{'measurements': [{'value': '-73', 'spread': '23', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '16 Weeks', 'unitOfMeasure': 'percent change in lesion count', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Dapsone Gel 7.5%', 'description': 'Dapsone gel 7.5% to be applied to truncal acne once daily for 16 weeks.\n\nDapsone 7.5 % gel: Dapsone gel 7.5% applied once daily to truncal acne'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Dapsone Gel 7.5%', 'description': 'Dapsone gel 7.5% to be applied to truncal acne once daily for 16 weeks.\n\nDapsone 7.5 % gel: Dapsone gel 7.5% applied once daily to truncal acne'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '21', 'spread': '8', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '16', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-06-01', 'size': 313462, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-02-06T13:32', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2017-09-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-03-20', 'studyFirstSubmitDate': '2016-10-04', 'resultsFirstSubmitDate': '2019-02-07', 'studyFirstSubmitQcDate': '2016-10-24', 'lastUpdatePostDateStruct': {'date': '2019-04-03', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-02-07', 'studyFirstPostDateStruct': {'date': '2016-10-25', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-03-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent of Subjects Who Achieve at Least a Two Grade Improvement and a Rating of Clear or Almost Clear on the Investigator Global Assessment (IGA) Scale', 'timeFrame': '16 weeks', 'description': 'Investigator will evaluate global acne severity using the IGA scale as follows: 1= Clear Skin, 2 = Almost Clear, 3 = Mild Severity, 4 = Severe, 5 = Very Severe'}], 'secondaryOutcomes': [{'measure': 'The Percent Change in Inflammatory Lesion Count at Week 16 Compared to Baseline', 'timeFrame': '16 Weeks'}, {'measure': 'The Percent Change in Non-inflammatory Lesion Count at Week 16 Compared to Baseline', 'timeFrame': '16 Weeks'}, {'measure': 'The Percent Change in Total Lesion Count at Week 16 Compared to Baseline', 'timeFrame': '16 Weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Acne']}, 'descriptionModule': {'briefSummary': 'To determine if Dapsone (Aczone) 7.5% gel is a safe and effective treatment for acne on the trunk', 'detailedDescription': 'This is an open label pilot study to determine the safety and efficacy of Dapsone (Aczone) 7.5% gel applied daily to the trunk for acne. Subjects will apply Dapsone for 16 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male and female subjects of any race and at least 12 years of age.\n* Female subjects of childbearing potential must have a negative urine pregnancy test at Baseline and practice a reliable method of contraception throughout the study.\n* Truncal acne IGA score of 3.\n* Able to understand the requirements of study and sign Informed Consent/HIPAA forms.\n\nExclusion Criteria:\n\n* Female subjects who are pregnant , breast feeding or are of childbearing potential who are not willing to use a reliable method birth control.\n* Subjects who have an allergy or sensitivity to any component of the test medication.\n* Subjects who have not complied with the proper wash out periods for prohibited medications.\n* Evidence of recent drug or alcohol abuse.\n* Skin disease /disorder that might interfere with the diagnosis or evaluation of truncal acne.\n* Exposure to an investigational drug within 30 days of the Baseline visit.\n* Medical condition that contraindicates the subject's participation in the study.\n* History of poor cooperation, non-compliance with medical treatment or unreliability."}, 'identificationModule': {'nctId': 'NCT02944461', 'briefTitle': 'Efficacy and Safety of Aczone 7.5% Gel in the Treatment of Truncal Acne Vulgaris', 'organization': {'class': 'OTHER', 'fullName': 'Derm Research, PLLC'}, 'officialTitle': 'Efficacy and Safety of Aczone 7.5% Gel in the Treatment of Truncal Acne Vulgaris', 'orgStudyIdInfo': {'id': 'ACZ1601'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dapsone gel 7.5%', 'description': 'Dapsone gel 7.5% to be applied to truncal acne once daily for 16 weeks.', 'interventionNames': ['Drug: Dapsone 7.5 % gel']}], 'interventions': [{'name': 'Dapsone 7.5 % gel', 'type': 'DRUG', 'otherNames': ['Aczone'], 'description': 'Dapsone gel 7.5% applied once daily to truncal acne', 'armGroupLabels': ['Dapsone gel 7.5%']}]}, 'contactsLocationsModule': {'locations': [{'zip': '95819', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'Dermatology and Laser Surgery', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '40014', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'DermResearch, PLLC', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '89117', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'James Q. DelRosso DO, LLC', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}], 'overallOfficials': [{'name': 'Leon H. Kircik, M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'DermResearch PLLC'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Derm Research, PLLC', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}