Ignite Creation Date:
2025-12-24 @ 5:43 PM
Ignite Modification Date:
2026-04-17 @ 1:45 AM
Study NCT ID:
NCT03236168
Status:
COMPLETED
Last Update Posted:
2019-06-14
First Post:
2017-07-26
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Impact of Community Scabies Treatment on Head Lice Prevalence in the Solomon Islands
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': 'D007559', 'term': 'Ivermectin'}], 'ancestors': [{'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D061065', 'term': 'Polyketides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'michael.marks@lshtm.ac.uk', 'phone': '02079272566', 'title': 'Dr Michael Marks', 'organization': 'London School of Hygiene and Tropical Medicine'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '2 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Intervention Arm', 'description': 'This study consists of a single treatment arm. Patients will receive Ivermectin or where contraindicated (Pregnancy, Breastfeeding, Weight \\<15kg) Permethrin Cream and Malathion shampoo\n\nIvermectin: A single weight based dose of ivermectin\n\nPermethrin 5%: Permethrin cream is used in conjunction with Malathion shampoo when ivermectin is contra-indicated\n\nMalathion Shampoo 0.5%: Permethrin cream is used in conjunction with Malathion shampoo when ivermectin is contra-indicated', 'otherNumAtRisk': 118, 'deathsNumAtRisk': 118, 'otherNumAffected': 0, 'seriousNumAtRisk': 118, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Headlice', 'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Arm', 'description': 'This study consists of a single treatment arm. Patients will receive Ivermectin or where contraindicated (Pregnancy, Breastfeeding, Weight \\<15kg) Permethrin Cream and Malathion shampoo\n\nIvermectin: A single weight based dose of ivermectin\n\nPermethrin 5%: Permethrin cream is used in conjunction with Malathion shampoo when ivermectin is contra-indicated\n\nMalathion Shampoo 0.5%: Permethrin cream is used in conjunction with Malathion shampoo when ivermectin is contra-indicated'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '2 Weeks after treatment', 'description': 'Assessed in the study population by physical examination of hair', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Headlice', 'timeFrame': '48hrs after treatment', 'description': 'Assessed in the study population by physical examination of hair', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Headlice', 'timeFrame': '3 Months after treatment', 'description': 'Assessed in the study population by physical examination of hair', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Intervention Arm', 'description': 'This study consists of a single treatment arm. Patients will receive Ivermectin or where contraindicated (Pregnancy, Breastfeeding, Weight \\<15kg) Permethrin Cream and Malathion shampoo\n\nIvermectin: A single weight based dose of ivermectin\n\nPermethrin 5%: Permethrin cream is used in conjunction with Malathion shampoo when ivermectin is contra-indicated\n\nMalathion Shampoo 0.5%: Permethrin cream is used in conjunction with Malathion shampoo when ivermectin is contra-indicated'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '118'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '107'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Intervention Arm', 'description': 'This study consists of a single treatment arm. Patients will receive Ivermectin or where contraindicated (Pregnancy, Breastfeeding, Weight \\<15kg) Permethrin Cream and Malathion shampoo\n\nIvermectin: A single weight based dose of ivermectin\n\nPermethrin 5%: Permethrin cream is used in conjunction with Malathion shampoo when ivermectin is contra-indicated\n\nMalathion Shampoo 0.5%: Permethrin cream is used in conjunction with Malathion shampoo when ivermectin is contra-indicated'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '<= 10 years', 'categories': [{'measurements': [{'value': '32', 'groupId': 'BG000'}]}]}, {'title': '11-20 years', 'categories': [{'measurements': [{'value': '31', 'groupId': 'BG000'}]}]}, {'title': '>= 21 years', 'categories': [{'measurements': [{'value': '55', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '61', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '57', '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': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '118', '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': 'Solomon Islands', 'categories': [{'measurements': [{'value': '118', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Headline Prevalence', 'classes': [{'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-05-16', 'size': 235042, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-03-11T12:02', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 118}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2018-02-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-03-13', 'studyFirstSubmitDate': '2017-07-26', 'resultsFirstSubmitDate': '2018-11-08', 'studyFirstSubmitQcDate': '2017-07-27', 'lastUpdatePostDateStruct': {'date': '2019-06-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-03-13', 'studyFirstPostDateStruct': {'date': '2017-08-01', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2019-06-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Headlice', 'timeFrame': '2 Weeks after treatment', 'description': 'Assessed in the study population by physical examination of hair'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Headlice', 'timeFrame': '48hrs after treatment', 'description': 'Assessed in the study population by physical examination of hair'}, {'measure': 'Number of Participants With Headlice', 'timeFrame': '3 Months after treatment', 'description': 'Assessed in the study population by physical examination of hair'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Scabies', 'Head Lice']}, 'referencesModule': {'references': [{'pmid': '30252856', 'type': 'DERIVED', 'citation': 'Coscione S, Esau T, Kekeubata E, Diau J, Asugeni R, MacLaren D, Steer AC, Kositz C, Marks M. Impact of ivermectin administered for scabies treatment on the prevalence of head lice in Atoifi, Solomon Islands. PLoS Negl Trop Dis. 2018 Sep 25;12(9):e0006825. doi: 10.1371/journal.pntd.0006825. eCollection 2018 Sep.'}]}, 'descriptionModule': {'briefSummary': 'This is a pilot study evaluating if treatment for scabies also treats headlice in the same community', 'detailedDescription': 'Background:\n\nScabies and head lice are both ubiquitous ectoparasitic infections that have been identified as common public health problems in the Pacific Island Country Territories. Mass drug administration using ivermectin is increasingly recognised as an effective strategy for scabies treatment and control, however, its possible impact on prevalence of head lice has not been evaluated. Given that oral ivermectin is an effective treatment option for pediculosis capitis, we hypothesise that community treatment with ivermectin for scabies would also provide benefit by reducing prevalence of head lice infestation in the community. We aim to test this hypothesis with a small-scale pilot study in the Solomon Islands.\n\nMethodology:\n\nThe study would be carried out at the Atoifi Adventist Hospital campus, on the North-Eastern coast of the island of Malaita. The campus houses an estimated 180 individuals and all residents would be invited to participate in the study and be offered treatment.\n\nAt baseline all individuals would undergo a standardized examination to collect data on the presence of scabies, impetigo and head lice. Following examination individuals would be weighed and given directly observed standard treatment for scabies.\n\nTreatment for scabies consists of one oral dose of ivermectin (200 micrograms per kilogram) at day 1 and at day 8.\n\nIndividuals with contra-indications (pregnancy, breast feeding, weight under 15kg) would be offered the alternative of 5% permethrin cream and malathion shampoo.\n\nIndividuals would be re-examined at 48hours (to assess immediate killing of head lice) and again at 2 weeks. Final follow-up will be at 3 months to establish: 1) whether changes in head lice prevalence have been sustained 2) what the impact of treatment on scabies and impetigo with ivermectin is in this specific community.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All participants living in the community will be offered treatment\n\nExclusion Criteria:\n\n* Patients with a contradindication to study medication\n* Patients unable to provide consent'}, 'identificationModule': {'nctId': 'NCT03236168', 'briefTitle': 'Impact of Community Scabies Treatment on Head Lice Prevalence in the Solomon Islands', 'organization': {'class': 'OTHER', 'fullName': 'London School of Hygiene and Tropical Medicine'}, 'officialTitle': 'Impact of Community Scabies Treatment on Head Lice Prevalence in the Solomon Islands', 'orgStudyIdInfo': {'id': '14257'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Intervention Arm', 'description': 'This study consists of a single treatment arm. Patients will receive Ivermectin or where contraindicated (Pregnancy, Breastfeeding, Weight \\<15kg) Permethrin Cream and Malathion shampoo', 'interventionNames': ['Drug: Ivermectin', 'Drug: Permethrin 5%', 'Drug: Malathion Shampoo 0.5%']}], 'interventions': [{'name': 'Ivermectin', 'type': 'DRUG', 'description': 'A single weight based dose of ivermectin', 'armGroupLabels': ['Intervention Arm']}, {'name': 'Permethrin 5%', 'type': 'DRUG', 'description': 'Permethrin cream is used in conjunction with Malathion shampoo when ivermectin is contra-indicated', 'armGroupLabels': ['Intervention Arm']}, {'name': 'Malathion Shampoo 0.5%', 'type': 'DRUG', 'description': 'Permethrin cream is used in conjunction with Malathion shampoo when ivermectin is contra-indicated', 'armGroupLabels': ['Intervention Arm']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Atoifi', 'state': 'Malaita Province', 'country': 'Solomon Islands', 'facility': 'Atoifi Adventist Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Anonymised data may be made available alongside any future publications'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'London School of Hygiene and Tropical Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}