Ignite Creation Date:
2025-12-25 @ 5:02 AM
Ignite Modification Date:
2025-12-26 @ 4:03 AM
Study NCT ID:
NCT00731718
Status:
COMPLETED
Last Update Posted:
2008-08-11
First Post:
2008-04-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Control of Head Lice Infestations in Children and Adults
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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 543}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-08', 'completionDateStruct': {'date': '2008-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-08-08', 'studyFirstSubmitDate': '2008-04-23', 'studyFirstSubmitQcDate': '2008-08-08', 'lastUpdatePostDateStruct': {'date': '2008-08-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-08-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy of using heated air to kill head lice and their eggs', 'timeFrame': 'Through out'}], 'secondaryOutcomes': [{'measure': 'Safety of device', 'timeFrame': 'Through out'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Head Lice'], 'conditions': ['Pediculosis']}, 'referencesModule': {'references': [{'pmid': '17079567', 'type': 'BACKGROUND', 'citation': 'Goates BM, Atkin JS, Wilding KG, Birch KG, Cottam MR, Bush SE, Clayton DH. An effective nonchemical treatment for head lice: a lot of hot air. Pediatrics. 2006 Nov;118(5):1962-70. doi: 10.1542/peds.2005-1847.'}, {'pmid': '21337950', 'type': 'DERIVED', 'citation': 'Bush SE, Rock AN, Jones SL, Malenke JR, Clayton DH. Efficacy of the LouseBuster, a new medical device for treating head lice (Anoplura:Pediculidae). J Med Entomol. 2011 Jan;48(1):67-72. doi: 10.1603/me10122.'}], 'seeAlsoLinks': [{'url': 'http://headlice.org', 'label': 'National Pediculosis Association'}]}, 'descriptionModule': {'briefSummary': 'The goal of this study is to see if heated air will kill head lice and their eggs. The treatment visit is approximately 1 hour long with a follow up phone call.', 'detailedDescription': 'Head lice strikes fear into the hearts of parents of school age children. Ridding a child of head lice is one of the most frustrating experiences a parent can face.\n\nThe objective of this project is to test whether louse desiccation using our prototype is an effective means of controlling head louse infestations in children.\n\nChildren age 6 and over are included in this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Must be at least 6 years old, male or female Parent to attend treatment Able to comb the hair with no problems\n\nExclusion Criteria:\n\n* Chemical shampoos used within 14 days Open sores or wounds on the scalp Recent head radiation'}, 'identificationModule': {'nctId': 'NCT00731718', 'briefTitle': 'Control of Head Lice Infestations in Children and Adults', 'organization': {'class': 'INDUSTRY', 'fullName': 'Larada Sciences, Inc.'}, 'officialTitle': 'Control of Head Lice in Children and Adults', 'orgStudyIdInfo': {'id': 'LS/LB-001'}, 'secondaryIdInfos': [{'id': 'IRB 008018'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'lousebuster', 'type': 'DEVICE', 'description': 'Subject serves as own control the length of treatment is approximately 30 minutes for full head treatment'}]}, 'contactsLocationsModule': {'locations': [{'zip': '84103', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'Larada Sciences,Inc.', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}], 'overallOfficials': [{'name': 'Dale Clayton, PhD/Biology', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Larada Sciences Inc., University of Utah'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Larada Sciences, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Dale Clayton, PhD', 'oldOrganization': 'Larada Sciences, Inc.'}}}}