Ignite Creation Date:
2025-12-24 @ 10:47 PM
Ignite Modification Date:
2025-12-25 @ 8:17 PM
Study NCT ID:
NCT04205669
Status:
COMPLETED
Last Update Posted:
2020-11-13
First Post:
2019-12-18
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Comparing the Effectiveness of Individual vs. Household Treatment for Scabies in Lambaréné, Gabon
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012532', 'term': 'Scabies'}], 'ancestors': [{'id': 'D008924', 'term': 'Mite Infestations'}, {'id': 'D004478', 'term': 'Ectoparasitic Infestations'}, {'id': 'D012876', 'term': 'Skin Diseases, Parasitic'}, {'id': 'D010272', 'term': 'Parasitic Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D012874', 'term': 'Skin Diseases, Infectious'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C006723', 'term': 'benzyl benzoate'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'julianmatthewman@gmail.com', 'phone': '00241 07-98-91-91', 'title': 'Julian Matthewman', 'organization': 'CERMEL'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'over the study follow up period, an average of 4 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Individual Treatment', 'description': 'Benzyl Benzoate 25% Topical Application Lotion: Applied to skin for the treatment of scabies', 'otherNumAtRisk': 47, 'deathsNumAtRisk': 47, 'otherNumAffected': 0, 'seriousNumAtRisk': 47, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Household Treatment', 'description': 'Benzyl Benzoate 25% Topical Application Lotion: Applied to skin for the treatment of scabies', 'otherNumAtRisk': 57, 'deathsNumAtRisk': 57, 'otherNumAffected': 0, 'seriousNumAtRisk': 57, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Clinical Cure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Individual Treatment', 'description': 'Benzyl Benzoate 25% Topical Application Lotion: Applied to skin for the treatment of scabies'}, {'id': 'OG001', 'title': 'Household Treatment', 'description': 'Benzyl Benzoate 25% Topical Application Lotion: Applied to skin for the treatment of scabies'}], 'classes': [{'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'after 28 days from baseline', 'description': 'clinical improvement in skin lesions with no new lesions occurring since treatment application as assessed by skin examination', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Proportion of Affected Household Members Per Household', 'timeFrame': 'after 28 days from baseline', 'description': 'proportion of scabies cases per household after 4 weeks', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Individual Treatment', 'description': 'Benzyl Benzoate 25% Topical Application Lotion: Applied to skin for the treatment of scabies'}, {'id': 'FG001', 'title': 'Household Treatment', 'description': 'Benzyl Benzoate 25% Topical Application Lotion: Applied to skin for the treatment of scabies'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '47'}, {'groupId': 'FG001', 'numSubjects': '57'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '45'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '12'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'BG000'}, {'value': '57', 'groupId': 'BG001'}, {'value': '104', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Individual Treatment', 'description': 'Benzyl Benzoate 25% Topical Application Lotion: Applied to skin for the treatment of scabies'}, {'id': 'BG001', 'title': 'Household Treatment', 'description': 'Benzyl Benzoate 25% Topical Application Lotion: Applied to skin for the treatment of scabies'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '<12 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'BG000'}, {'value': '57', 'groupId': 'BG001'}, {'value': '104', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '65', 'groupId': 'BG002'}]}]}, {'title': '>=12 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'BG000'}, {'value': '57', 'groupId': 'BG001'}, {'value': '104', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'BG000'}, {'value': '57', 'groupId': 'BG001'}, {'value': '104', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Scabies severity', 'classes': [{'title': 'Mild', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'BG000'}, {'value': '57', 'groupId': 'BG001'}, {'value': '104', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}, {'title': 'Moderate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'BG000'}, {'value': '57', 'groupId': 'BG001'}, {'value': '104', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}]}, {'title': 'Severe', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'BG000'}, {'value': '57', 'groupId': 'BG001'}, {'value': '104', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Malaria rapid diagnostic test status', 'classes': [{'title': 'Positive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'BG000'}, {'value': '57', 'groupId': 'BG001'}, {'value': '104', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}]}, {'title': 'Negative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'BG000'}, {'value': '57', 'groupId': 'BG001'}, {'value': '104', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-08-31', 'size': 221331, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-10-21T05:46', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 104}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-10-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2019-02-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-21', 'studyFirstSubmitDate': '2019-12-18', 'resultsFirstSubmitDate': '2020-07-08', 'studyFirstSubmitQcDate': '2019-12-18', 'lastUpdatePostDateStruct': {'date': '2020-11-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-10-21', 'studyFirstPostDateStruct': {'date': '2019-12-19', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-11-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-02-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Clinical Cure', 'timeFrame': 'after 28 days from baseline', 'description': 'clinical improvement in skin lesions with no new lesions occurring since treatment application as assessed by skin examination'}], 'secondaryOutcomes': [{'measure': 'Proportion of Affected Household Members Per Household', 'timeFrame': 'after 28 days from baseline', 'description': 'proportion of scabies cases per household after 4 weeks'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Scabies', 'Households']}, 'referencesModule': {'availIpds': [{'url': 'https://www.kaggle.com/julianmatthewman/grattigratta-data', 'type': 'Individual Participant Data Set'}], 'references': [{'pmid': '32589632', 'type': 'DERIVED', 'citation': "Matthewman J, Manego RZ, Dimessa Mbadinga LB, Sinkovec H, Volker K, Akinosho M, Haedrich C, Tardif d'Hamonville J, Lell B, Adegnika AA, Ramharter M, Mombo-Ngoma G. A randomized controlled trial comparing the effectiveness of individual versus household treatment for Scabies in Lambarene, Gabon. PLoS Negl Trop Dis. 2020 Jun 26;14(6):e0008423. doi: 10.1371/journal.pntd.0008423. eCollection 2020 Jun."}]}, 'descriptionModule': {'briefSummary': 'It is unclear whether individual treatment of scabies is similarly effective compared to household treatment. This study therefore compares these two treatment strategies with topical benzyl benzoate for treating scabies in Lambaréné and surroundings in Gabon.\n\nSubjects presenting with uncomplicated scabies are randomized into either the Individual Treatment group, where only the affected subjects receive treatment, or the Household Treatment group, where all family members are treated in parallel to the affected subjects regardless of signs and symptoms. The primary endpoint is clinical cure after 28 days; the secondary endpoint is the proportion of affected household members per household after 28 days.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* diagnosed with active, uncomplicated scabies\n* no known hypersensitivity or allergy against benzyl benzoate\n\nExclusion Criteria:\n\n* hypersensitivity or allergy against benzyl benzoate\n* severe superinfection of scabies lesions'}, 'identificationModule': {'nctId': 'NCT04205669', 'briefTitle': 'Comparing the Effectiveness of Individual vs. Household Treatment for Scabies in Lambaréné, Gabon', 'organization': {'class': 'OTHER', 'fullName': 'Centre de Recherche Médicale de Lambaréné'}, 'officialTitle': 'A Randomized Controlled Trial Comparing the Effectiveness of Individual vs. Household Treatment for Scabies in Lambaréné, Gabon', 'orgStudyIdInfo': {'id': 'GrattiGratta31082018'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Individual Treatment', 'interventionNames': ['Drug: Benzyl Benzoate 25% Topical Application Lotion']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Household Treatment', 'interventionNames': ['Drug: Benzyl Benzoate 25% Topical Application Lotion']}], 'interventions': [{'name': 'Benzyl Benzoate 25% Topical Application Lotion', 'type': 'DRUG', 'description': 'Applied to skin for the treatment of scabies', 'armGroupLabels': ['Household Treatment', 'Individual Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'BP 242', 'city': 'Lambaréné', 'country': 'Gabon', 'facility': 'Centre de Recherches Médicales de Lambaréné', 'geoPoint': {'lat': -0.7001, 'lon': 10.24055}}]}, 'ipdSharingStatementModule': {'url': 'https://www.kaggle.com/julianmatthewman/grattigratta-data', 'ipdSharing': 'YES', 'description': 'IPD with identifying data removed uploaded to public repository under https://www.kaggle.com/julianmatthewman/grattigratta-data'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre de Recherche Médicale de Lambaréné', 'class': 'OTHER'}, 'collaborators': [{'name': 'Bernhard Nocht Institute for Tropical Medicine', 'class': 'OTHER_GOV'}, {'name': 'University Hospital Tuebingen', 'class': 'OTHER'}, {'name': 'Medical University of Vienna', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Julian Matthewman', 'investigatorAffiliation': 'Centre de Recherche Médicale de Lambaréné'}}}}