Ignite Creation Date:
2025-12-25 @ 4:30 AM
Ignite Modification Date:
2025-12-26 @ 3:32 AM
Study NCT ID:
NCT00262418
Status:
COMPLETED
Last Update Posted:
2007-12-28
First Post:
2005-12-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison of the Efficacy and Safety of Ivermectin to Permethrin
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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': 'D026023', 'term': 'Permethrin'}], 'ancestors': [{'id': 'D010647', 'term': 'Phenyl Ethers'}, {'id': 'D004987', 'term': 'Ethers'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D011722', 'term': 'Pyrethrins'}, {'id': 'D000081004', 'term': 'Cyclopentane Monoterpenes'}, {'id': 'D039821', 'term': 'Monoterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 160}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-12', 'completionDateStruct': {'date': '2005-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2007-12-19', 'studyFirstSubmitDate': '2005-12-04', 'studyFirstSubmitQcDate': '2005-12-04', 'lastUpdatePostDateStruct': {'date': '2007-12-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-12-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical healing of the skin injuries', 'timeFrame': 'on day28'}], 'secondaryOutcomes': [{'measure': 'Decrease of itching', 'timeFrame': 'on day28'}, {'measure': 'Amelioration of the life quality', 'timeFrame': 'on day28'}, {'measure': 'Number and gravity of adverse events'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Scabies']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.uzgent.be', 'label': 'Website of the University Hospital Ghent'}]}, 'descriptionModule': {'briefSummary': 'Comparison of the efficacy and safety of a single administration of ivermectin to a single administration of permethrin for the treatment of scabies', 'detailedDescription': 'Administration of ivermectin or permethrin on day0 Clinical examination and pictures on day0, day14 and day28 Blood sample on day0 VAS for pruritus, DLQI and SF-36 on day0, day14 and day28'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '5 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAt least one of the following inclusion criteria:\n\n* Scabies tunnels\n* Positive microscopic examination (acarids, faeces or ova)\n\nAt least two of the three following inclusion criteria:\n\n* Non-specific injuries with a typical distribution pattern\n* Serious itching which increases during the night\n* Family or contacts with similar complaints\n\nExclusion Criteria:\n\n* Treatment for scabies \\< 4 weeks ago\n* Treatment with corticoids \\< 1 week ago\n* Pregnancy\n* Breast-feeding\n* HIV\n* Serious immunodepressive patients\n* Sensitivity or allergy to one of the components of the study medication\n* Damage of the central nerve system'}, 'identificationModule': {'nctId': 'NCT00262418', 'briefTitle': 'Comparison of the Efficacy and Safety of Ivermectin to Permethrin', 'organization': {'class': 'OTHER', 'fullName': 'University Ghent'}, 'officialTitle': 'A Randomised, Double Blind, Double Dummy Study to Compare the Efficacy and Safety of a Single Administration of Ivermectin to a Single Administration of Permethrin for the Treatment of Scabies', 'orgStudyIdInfo': {'id': '2004/212'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Administration of ivermectin or permethrin', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '9000', 'city': 'Ghent', 'country': 'Belgium', 'facility': 'University Hospital Ghent', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}], 'overallOfficials': [{'name': 'Jean-Marie Naeyaert, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Ghent'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Ghent', 'class': 'OTHER'}}}}