Ignite Creation Date:
2025-12-25 @ 4:10 AM
Ignite Modification Date:
2025-12-26 @ 3:07 AM
Study NCT ID:
NCT00819520
Status:
COMPLETED
Last Update Posted:
2011-08-22
First Post:
2009-01-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Ivermectin in the Treatment of Head Lice
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010373', 'term': 'Lice Infestations'}], 'ancestors': [{'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'}, {'id': 'D008294', 'term': 'Malathion'}], 'ancestors': [{'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D061065', 'term': 'Polyketides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D063086', 'term': 'Organothiophosphates'}, {'id': 'D010755', 'term': 'Organophosphates'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D009946', 'term': 'Organothiophosphorus Compounds'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 812}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-08', 'completionDateStruct': {'date': '2004-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-08-19', 'studyFirstSubmitDate': '2009-01-08', 'studyFirstSubmitQcDate': '2009-01-08', 'lastUpdatePostDateStruct': {'date': '2011-08-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-01-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2004-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Absence or presence of live head lice', 'timeFrame': 'Study Day 15'}], 'secondaryOutcomes': [{'measure': 'Absence or presence of live head lice at alternative Study Days.', 'timeFrame': 'Study Days 2, 8, 22, 29'}, {'measure': 'Safety Assessments will consist of monitoring and recording all non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs), their frequency, severity, seriousness, and relationship to the investigational product.', 'timeFrame': 'throughout duration of the study (+ 30 days for spontaneously reported SAEs)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['pediculosis capitis', 'pediculus'], 'conditions': ['Lice Infestations']}, 'referencesModule': {'references': [{'pmid': '20220184', 'type': 'DERIVED', 'citation': 'Chosidow O, Giraudeau B, Cottrell J, Izri A, Hofmann R, Mann SG, Burgess I. Oral ivermectin versus malathion lotion for difficult-to-treat head lice. N Engl J Med. 2010 Mar 11;362(10):896-905. doi: 10.1056/NEJMoa0905471.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare 2 single doses of ivermectin as tablets with 2 single applications of malathion 0.5% lotion (Days 1 and 8) in clearing head lice, in patients who have recently used standard head lice treatments without success.', 'detailedDescription': 'Head lice infestation occurs frequently, primarily in children 3 to 11 years of age. In recent years an increasing prevalence of lice infestation in schools, day care centres, and summer day camps is believed to be partly due to increasing lice resistance to currently available standard treatments for pediculosis (infestation with lice). There is a need for new effective backup treatments for this common condition of head lice infestation. This is a double-blind, randomized, parallel-group, study in several clinical centres comparing ivermectin as tablets to malathion 0.5% lotion in the treatment of head lice. All enrolled patients participate in the primary phase of the study up to the Day 15 evaluation. Patients who are still infested with lice at Day 15 (treatment failures) will enter an extension phase and be treated in a double-blind, fashion with the opposite treatment (ie ivermectin or malathion). The study hypothesis is that ivermectin will be more effective than malathion in clearing head lice infestation , as measured by the proportion of patients who are lice-free at Study Day 15.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Head lice infestation confirmed by detection combing by study staff\n* previous (within 6 weeks) use of a topical insecticide product\n* minimum 15kg weight\n* providing informed consent\n\nExclusion Criteria:\n\n* pregnant or nursing patients\n* households with 7 or more infested patients\n* households where there are other known infested household members not participating\n* head lice treatment within 2 weeks of entry\n* active scalp infection\n* any difficulty with combing assessment\n* patient from region endemic for certain parasitic worm diseases'}, 'identificationModule': {'nctId': 'NCT00819520', 'briefTitle': 'Ivermectin in the Treatment of Head Lice', 'organization': {'class': 'INDUSTRY', 'fullName': 'Johnson & Johnson Consumer and Personal Products Worldwide'}, 'officialTitle': 'A Randomised, Double-Blind, Multicentre Study to Compare the Efficacy and Tolerability of Oral Ivermectin to Malathion 0.5% Lotion in the Treatment of Head Lice Infestation', 'orgStudyIdInfo': {'id': '075-00'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ivermectin', 'description': 'ivermectin Stromectol®)', 'interventionNames': ['Drug: ivermectin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Malathion', 'description': 'malathion(Prioderm®)', 'interventionNames': ['Drug: malathion']}], 'interventions': [{'name': 'ivermectin', 'type': 'DRUG', 'otherNames': ['Stromectol®'], 'description': 'Two single doses of oral ivermectin 400 mcg/kg (Days 1 and 8) plus 2 single applications of placebo lotion', 'armGroupLabels': ['Ivermectin']}, {'name': 'malathion', 'type': 'DRUG', 'otherNames': ['Prioderm®'], 'description': 'Two single applications of malathion 0.5% lotion (Days 1 and 8) plus 2 single doses of placebo tablets', 'armGroupLabels': ['Malathion']}]}, 'contactsLocationsModule': {'locations': [{'zip': '93009', 'city': 'Bobigny', 'state': 'Paris', 'country': 'France', 'facility': 'Hopital Avicenne', 'geoPoint': {'lat': 48.90982, 'lon': 2.45012}}, {'city': 'Cork', 'state': 'Co. Cork', 'country': 'Ireland', 'facility': 'Shandon Clinic', 'geoPoint': {'lat': 51.89797, 'lon': -8.47061}}, {'zip': '52621', 'city': 'Tel Litwinsky', 'state': 'Tel Hashomer', 'country': 'Israel', 'facility': 'Chaim Sheba Medical Centre', 'geoPoint': {'lat': 32.05096, 'lon': 34.84588}}, {'zip': 'RG2 7AG', 'city': 'Reading', 'state': 'Berks', 'country': 'United Kingdom', 'facility': 'Synexus Clinical Research Centre', 'geoPoint': {'lat': 51.45625, 'lon': -0.97113}}], 'overallOfficials': [{'name': 'Jerry Cottrell', 'role': 'STUDY_DIRECTOR', 'affiliation': 'J&J Consumer and Personal Products Worldwide'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johnson & Johnson Consumer and Personal Products Worldwide', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}