Ignite Creation Date:
2025-12-24 @ 6:35 PM
Ignite Modification Date:
2025-12-30 @ 6:10 PM
Study NCT ID:
NCT00291057
Status:
TERMINATED
Last Update Posted:
2013-12-23
First Post:
2006-02-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Tolerability of a Novel Malathion Formulation in Infants and Toddlers With 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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'whyStopped': 'Lack of enrollment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2006-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-11', 'completionDateStruct': {'date': '2006-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-12-19', 'studyFirstSubmitDate': '2006-02-10', 'studyFirstSubmitQcDate': '2006-02-10', 'lastUpdatePostDateStruct': {'date': '2013-12-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-02-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in cholinesterase level', 'timeFrame': '1 day'}], 'secondaryOutcomes': [{'measure': 'Clinical evidence of cholinesterase inhibition', 'timeFrame': '1 day'}, {'measure': 'Local tolerability', 'timeFrame': '1 day'}, {'measure': 'Cure of head lice 14 days after last treatment', 'timeFrame': '2 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Pediculosis', 'Head Lice'], 'conditions': ['Lice Infestations']}, 'descriptionModule': {'briefSummary': 'In a previous phase II study, the safety and efficacy of a novel formulation of malathion 0.5% was evaluated in patients 2 years of age and older. Based on the results of that study, this formulation is currently in a phase III study for that population.\n\nThe current study will use blood markers and clinical evaluations to determine the safety and tolerability of this formulation when used in children 6-24 months of age.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '24 Months', 'minimumAge': '6 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Confirmed active head lice infestation\n* Parent or guardian must be able to apply treatment\n\nExclusion Criteria:\n\n* Allergy to pediculicides or hair care products\n* Scalp conditions other than head lice\n* Previous head lice treatment within the past 4 weeks\n* Current antibiotic treatment'}, 'identificationModule': {'nctId': 'NCT00291057', 'briefTitle': 'Safety and Tolerability of a Novel Malathion Formulation in Infants and Toddlers With Head Lice', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sun Pharmaceutical Industries, Inc.'}, 'officialTitle': 'Phase II, Multi-center, Open-Label, Safety and Tolerance Study of a Novel Malathion Formulation in Infants and Toddlers With Pediculosis Capitis', 'orgStudyIdInfo': {'id': 'MALG-0508'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'MALG', 'interventionNames': ['Drug: MALG']}], 'interventions': [{'name': 'MALG', 'type': 'DRUG', 'description': '30 minute application', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Investigator Site', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'city': 'St. Petersburg', 'state': 'Florida', 'country': 'United States', 'facility': 'Investigator Site', 'geoPoint': {'lat': 27.77086, 'lon': -82.67927}}, {'city': 'West Palm Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Investigator Site', 'geoPoint': {'lat': 26.71534, 'lon': -80.05337}}, {'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Investigator Site', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'city': 'Miamiville', 'state': 'Ohio', 'country': 'United States', 'facility': 'Investigator Site', 'geoPoint': {'lat': 39.21256, 'lon': -84.29938}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sun Pharmaceutical Industries, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Medical Director', 'oldOrganization': 'Taro Pharmaceuticals USA'}}}}