Ignite Creation Date:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2026-01-10 @ 12:38 AM
Study NCT ID:
NCT03257202
Status:
COMPLETED
Last Update Posted:
2019-11-13
First Post:
2017-08-01
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Topical Treatment and Prevalence of P. Acnes
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013530', 'term': 'Surgical Wound Infection'}], 'ancestors': [{'id': 'D014946', 'term': 'Wound Infection'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002981', 'term': 'Clindamycin'}, {'id': 'D005782', 'term': 'Gels'}, {'id': 'D001585', 'term': 'Benzoyl Peroxide'}, {'id': 'C466951', 'term': 'clindamycin phosphate benzoyl peroxide combination'}], 'ancestors': [{'id': 'D008034', 'term': 'Lincomycin'}, {'id': 'D055231', 'term': 'Lincosamides'}, {'id': 'D011759', 'term': 'Pyrrolidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D003102', 'term': 'Colloids'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D004304', 'term': 'Dosage Forms'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D001565', 'term': 'Benzoates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ghatch.md@gmail.com', 'phone': '323-442-5860', 'title': 'Dr. George Hatch', 'organization': 'Keck Medical Center of USC'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '24 days', 'eventGroups': [{'id': 'EG000', 'title': 'Control', 'description': 'No topical treatment', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 0, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Clindamycin Alone', 'description': 'topical clindamycin alone using Clindamycin 1% Gel\n\nClindamycin 1% Gel: topical clindamycin', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 0, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Benzoyl Peroxide Alone', 'description': 'topical benzoyl peroxide alone using Benzoyl Peroxide 5% Gel\n\nBenzoyl peroxide 5% gel: topical benzoyl peroxide', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 0, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Clindamycin and Benzoyl Peroxide', 'description': 'Topical clindamycin and topical benzoyl peroxide together using BenzaClin 5%-1% Topical Gel\n\nBenzaClin 5%-1% Topical Gel: Topical clindamycin and benzoyl peroxide together', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 0, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Subjects With Positive Bacterial Growth Culture Per Treatment Arms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Negative Control', 'description': 'The participants did not receive treatment in this quadrant.'}, {'id': 'OG001', 'title': 'Benzoyl Peroxide 5% Topical Gel', 'description': "This quadrant on the participants' backs were treated with Benzoyl Peroxide 5% topical gel"}, {'id': 'OG002', 'title': 'Clindamycin 1% Topical Gel', 'description': "This quadrant of the participants' back received Clindamycin 1% topical gel"}, {'id': 'OG003', 'title': 'Clindamycin 1% Plus Benzoyl Peroxide 5% Topical Gel', 'description': "This quadrant on the study participants' backs were treated with Clindamycin 1% plus Benzoyl Peroxide 5% topical gel"}], 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '21 days', 'description': 'Detected presence of growth of Propionibacterium acnes on bacterial culture (bacteria per mL) by treatment arms.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'All Study Participants', 'description': 'All study participants received all 4 treatments: control, Clindamycin alone, Benzyl peroxide alone, Clindamycin and Benzoyl Peroxide'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'All 12 patients received each of the 4 study arms.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Study Participants', 'description': '1. Negative Control\n2. Topical benzoyl peroxide alone using Benzoyl Peroxide 5% Gel\n3. Topical clindamycin alone using Clindamycin 1% Gel\n4. BenzaClin 5%-1% Topical Gel: Topical clindamycin and benzoyl peroxide together'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '29.4', 'groupId': 'BG000', 'lowerLimit': '26', 'upperLimit': '40'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-07-02', 'size': 433352, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-07-12T18:23', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Healthy volunteers'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-09-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2018-01-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-10-25', 'studyFirstSubmitDate': '2017-08-01', 'resultsFirstSubmitDate': '2019-06-20', 'studyFirstSubmitQcDate': '2017-08-17', 'lastUpdatePostDateStruct': {'date': '2019-11-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-10-25', 'studyFirstPostDateStruct': {'date': '2017-08-22', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2019-11-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Subjects With Positive Bacterial Growth Culture Per Treatment Arms', 'timeFrame': '21 days', 'description': 'Detected presence of growth of Propionibacterium acnes on bacterial culture (bacteria per mL) by treatment arms.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Propionibacterium Acnes', 'Surgical Site Infection', 'Shoulder'], 'conditions': ['Surgical Site Infection']}, 'referencesModule': {'availIpds': [{'id': 'HS-17-00319', 'url': 'http://istar.usc.edu', 'type': 'Study Protocol'}, {'id': 'HS-17-00319', 'url': 'http://istar.usc.edu', 'type': 'Informed Consent Form'}], 'references': [{'pmid': '23543526', 'type': 'BACKGROUND', 'citation': 'Dumville JC, McFarlane E, Edwards P, Lipp A, Holmes A. Preoperative skin antiseptics for preventing surgical wound infections after clean surgery. Cochrane Database Syst Rev. 2013 Mar 28;(3):CD003949. doi: 10.1002/14651858.CD003949.pub3.'}, {'pmid': '24897745', 'type': 'BACKGROUND', 'citation': 'Mook WR, Garrigues GE. Diagnosis and Management of Periprosthetic Shoulder Infections. J Bone Joint Surg Am. 2014 Jun 4;96(11):956-965. doi: 10.2106/JBJS.M.00402. Epub 2014 Jun 4.'}, {'pmid': '24306704', 'type': 'BACKGROUND', 'citation': 'Matsen FA 3rd, Butler-Wu S, Carofino BC, Jette JL, Bertelsen A, Bumgarner R. Origin of propionibacterium in surgical wounds and evidence-based approach for culturing propionibacterium from surgical sites. J Bone Joint Surg Am. 2013 Dec 4;95(23):e1811-7. doi: 10.2106/JBJS.L.01733.'}, {'pmid': '25187583', 'type': 'BACKGROUND', 'citation': 'Lee MJ, Pottinger PS, Butler-Wu S, Bumgarner RE, Russ SM, Matsen FA 3rd. Propionibacterium persists in the skin despite standard surgical preparation. J Bone Joint Surg Am. 2014 Sep 3;96(17):1447-50. doi: 10.2106/JBJS.M.01474.'}, {'pmid': '19651954', 'type': 'BACKGROUND', 'citation': 'Saltzman MD, Nuber GW, Gryzlo SM, Marecek GS, Koh JL. Efficacy of surgical preparation solutions in shoulder surgery. J Bone Joint Surg Am. 2009 Aug;91(8):1949-53. doi: 10.2106/JBJS.H.00768.'}, {'pmid': '27773990', 'type': 'BACKGROUND', 'citation': 'Wright TE, Boyle KK, Duquin TR, Crane JK. Propionibacterium acnes Susceptibility and Correlation with Hemolytic Phenotype. Infect Dis (Auckl). 2016 Oct 9;9:39-44. doi: 10.4137/IDRT.S40539. eCollection 2016.'}, {'pmid': '15912075', 'type': 'BACKGROUND', 'citation': 'Hibbard JS. Analyses comparing the antimicrobial activity and safety of current antiseptic agents: a review. J Infus Nurs. 2005 May-Jun;28(3):194-207. doi: 10.1097/00129804-200505000-00008.'}, {'pmid': '21543562', 'type': 'BACKGROUND', 'citation': 'Butler-Wu SM, Burns EM, Pottinger PS, Magaret AS, Rakeman JL, Matsen FA 3rd, Cookson BT. Optimization of periprosthetic culture for diagnosis of Propionibacterium acnes prosthetic joint infection. J Clin Microbiol. 2011 Jul;49(7):2490-5. doi: 10.1128/JCM.00450-11. Epub 2011 May 4.'}]}, 'descriptionModule': {'briefSummary': 'This study is about preventing surgical site infections of the shoulder. We hope to learn if clindamycin alone, benzoyl peroxide alone, or clindamycin and benzoyl peroxide together can affect growth of Propionibacterium acnes in the dermal layer.', 'detailedDescription': 'P. acnes are skin pathogens known to cause surgical site infections despite proper preoperative surgical preparation. Lee et al. showed 70% growth rate of P. acnes despite the application of Choraprep prior to sampling. However, this study was limited as it failed to utilize a control group and only investigated one preparatory technique. Meanwhile, there remains to date no study investigating the effect of topical treatments. The purpose of this study is to investigate how specific topical treatments affect growth in the dermal layer. 12 volunteers who are normal volunteers, students, or employees of USC will each receive 4 punch biopsies from their back above the scapular spine, with each biopsy taken from a region of the skin treated with a different topical (topical clindamycin alone, topical benzoyl peroxide alone, topical clindamycin and benzoyl peroxide together, and a control). A 3df overall test of the treatment indicators will test for any differences in positivity for P Acnes among the treatments; pairwise comparisons among the treatments will adjust for multiple comparisons. A two-tailed statistical test will be performed, testing at an alpha of 0.05, and analyses will also be performed based on hemolytic subtypes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* healthy volunteer\n* age \\> 18\n\nExclusion Criteria:\n\n* history of antibiotic use in the last month\n* active acne on the back\n* non-English speakers (the study personnel do not have adequate training to converse and consent in other languages)'}, 'identificationModule': {'nctId': 'NCT03257202', 'briefTitle': 'Topical Treatment and Prevalence of P. Acnes', 'organization': {'class': 'OTHER', 'fullName': 'University of Southern California'}, 'officialTitle': 'Cutibacterium Acnes Persists Despite Topical Clindamycin and Benzoyl Peroxide', 'orgStudyIdInfo': {'id': 'HS-17-00319'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'No topical treatment'}, {'type': 'EXPERIMENTAL', 'label': 'Clindamycin alone', 'description': 'topical clindamycin alone using Clindamycin 1% Gel', 'interventionNames': ['Drug: Clindamycin 1% Gel']}, {'type': 'EXPERIMENTAL', 'label': 'Benzoyl peroxide alone', 'description': 'topical benzoyl peroxide alone using Benzoyl Peroxide 5% Gel', 'interventionNames': ['Drug: Benzoyl peroxide 5% gel']}, {'type': 'EXPERIMENTAL', 'label': 'Clindamycin and benzoyl peroxide', 'description': 'Topical clindamycin and topical benzoyl peroxide together using BenzaClin 5%-1% Topical Gel', 'interventionNames': ['Drug: BenzaClin 5%-1% Topical Gel']}], 'interventions': [{'name': 'Clindamycin 1% Gel', 'type': 'DRUG', 'description': 'topical clindamycin', 'armGroupLabels': ['Clindamycin alone']}, {'name': 'Benzoyl peroxide 5% gel', 'type': 'DRUG', 'description': 'topical benzoyl peroxide', 'armGroupLabels': ['Benzoyl peroxide alone']}, {'name': 'BenzaClin 5%-1% Topical Gel', 'type': 'DRUG', 'description': 'Topical clindamycin and benzoyl peroxide together', 'armGroupLabels': ['Clindamycin and benzoyl peroxide']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Keck School of Medicine of the University of Southern California', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}], 'overallOfficials': [{'name': 'George R Hatch, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Southern California'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'ICF', 'CSR'], 'ipdSharing': 'YES', 'description': 'Yes Data will be shared as required with the USC Health Sciences Institutional Review Board. Participant data will be coded with coding identifiers kept separately by research personnel only and destroyed upon completion of the study.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Southern California', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'George F. Hatch', 'investigatorAffiliation': 'University of Southern California'}}}}