Ignite Creation Date:
2025-12-25 @ 2:45 AM
Ignite Modification Date:
2026-02-27 @ 12:07 AM
Study NCT ID:
NCT00988533
Status:
COMPLETED
Last Update Posted:
2012-04-25
First Post:
2009-10-01
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Pharmacokinetics (PK) Study in Lice Infested Children 6 Months to 3 Years of Age
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'RegistryContactUs@sanofipasteur.com', 'title': 'Medical Director', 'organization': 'Sanofi Topaz'}, 'certainAgreement': {'otherDetails': 'Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable subject matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse event data were collected from the day of application (Day 1) through Day 28 post-application', 'eventGroups': [{'id': 'EG000', 'title': '0.5% Ivermectin', 'description': 'Participants received a single application of 0.5% ivermectin on Day 1.', 'otherNumAtRisk': 30, 'otherNumAffected': 11, 'seriousNumAtRisk': 30, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Upper Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Alanine Aminotransferase Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 5}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}], 'seriousEvents': [{'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Dermatitis Diaper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}], 'frequencyThreshold': '5.00'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean Plasma Concentration of Ivermectin in Samples Collected Before Application and at Specified Post-Application Time Points', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '0.5% Ivermectin', 'description': 'Participants received a single application of 0.5% ivermectin on Day 1.'}], 'classes': [{'title': '0 Hour (N = 20)', 'categories': [{'measurements': [{'value': '0.00000', 'spread': '0.00000', 'groupId': 'OG000', 'lowerLimit': '0.00000'}]}]}, {'title': '0.5 Hour (N = 19)', 'categories': [{'measurements': [{'value': '0.02528', 'spread': '0.11018', 'groupId': 'OG000', 'lowerLimit': '0.11018'}]}]}, {'title': '1 Hour (N = 19)', 'categories': [{'measurements': [{'value': '0.08192', 'spread': '0.22695', 'groupId': 'OG000', 'lowerLimit': '0.22695'}]}]}, {'title': '6 Hours (N = 19)', 'categories': [{'measurements': [{'value': '0.20075', 'spread': '0.20456', 'groupId': 'OG000', 'lowerLimit': '0.20456'}]}]}, {'title': '24 Hours (N = 18)', 'categories': [{'measurements': [{'value': '0.16325', 'spread': '0.08983', 'groupId': 'OG000', 'lowerLimit': '0.08983'}]}]}, {'title': '168 Hours (N = 2)', 'categories': [{'measurements': [{'value': '0.05767', 'spread': 'NA', 'comment': 'Not calculated, insufficient samples', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Before; 0.5, 1, 6, 24 hours and Up to 14 days post-application', 'description': 'Plasma concentrations of ivermectin were measured by validated and appropriate bioanalytical instruments and methods with a sensitivity of 0.05 ng/mL before application and on Day 1 (0.5, 1, and 6 hours), Day 2 (24 hours post-application), Day 8 (7 days post-application), and Day 15 (14 days post-application).', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Plasma concentrations of Ivermectin were assessed in the pharmacokinetic (PK) population.'}, {'type': 'PRIMARY', 'title': 'Summary of Pharmacokinetic Parameters Following Ivermectin Application.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '0.5% Ivermectin', 'description': 'Participants received a single application of 0.5% ivermectin on Day 1.'}], 'classes': [{'title': 'Time Averaged Plasma Concentration', 'categories': [{'measurements': [{'value': '0.08708', 'spread': '0.11102', 'groupId': 'OG000', 'lowerLimit': '0.11102'}]}]}, {'title': 'Area Under Plasma Concentration Last', 'categories': [{'measurements': [{'value': '6.701', 'spread': '11.23', 'groupId': 'OG000', 'lowerLimit': '11.23'}]}]}, {'title': 'Area Under Plasma Concentration 0 to 24', 'categories': [{'measurements': [{'value': '3.972', 'spread': '3.5142', 'groupId': 'OG000', 'lowerLimit': '3.5142'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Before; 0.5, 1, 6, 24 hours, Day 8 and Day 15 post-application', 'description': 'Plasma concentrations of ivermectin were measured by validated and appropriate bioanalytical instruments and methods before application and on Day 1 (0.5, 1, and 6 hours post-application), Day 2 (24 hours post-application), Day 8 (7 days post-application), and Day 15 (14 days post-application).', 'unitOfMeasure': 'ng/h/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Plasma concentrations of Ivermectin were assessed in the pharmacokinetic (PK) population.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Reporting Adverse Events Following Ivermectin Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '0.5% Ivermectin', 'description': 'Participants received a single application of 0.5% ivermectin on Day 1.'}], 'classes': [{'title': 'Diarrhea', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Severe Diarrhea', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Vomiting', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Severe Vomiting', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Gastroenteritis', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Severe Gastroenteritis', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Nasopharyngitis', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Severe Nasopharyngitis', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Upper Respiratory Tract Infection', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Severe Upper Respiratory Tract Infection', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Alanine Aminotransferase Increased', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Severe Alanine Aminotransferase Increased', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Aspartate Aminotransferase Increased', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Severe Aspartate Aminotransferase Increased', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Dehydration', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Severe Dehydration', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Dermatitis Diaper', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Severe Dermatitis Diaper', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Erythema', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Severe Erythema', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Pruritus', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Severe Pruritus', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 up Day 28 post-application', 'description': 'Adverse events were assessed at each visit and during the follow up phone call on Day 28.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Adverse events were assessed in the intent-to-treat population.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Were Lice-Free by Visit Post-treatment With Ivermectin.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '0.5% Ivermectin', 'description': 'Participants received a single application of 0.5% ivermectin on Day 1.'}], 'classes': [{'title': 'Day 2 (N = 30)', 'categories': [{'measurements': [{'value': '97', 'groupId': 'OG000'}]}]}, {'title': 'Day 8 (N = 29)', 'categories': [{'measurements': [{'value': '90', 'groupId': 'OG000'}]}]}, {'title': 'Day 15 (N = 28)', 'categories': [{'measurements': [{'value': '89', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 2, Day 8 and Day 15 post-application', 'description': 'Eradication of live lice was assessed by visual examination of the scalp and hair.', 'unitOfMeasure': 'Percent of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Eradication of live lice was assessed in the intent-to-treat population.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Were Lice-Free by Day 2 That Were Maintained Through Day 8 and Day 15 Post-treatment With Ivermectin.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '0.5% Ivermectin', 'description': 'Participants received a single application of 0.5% ivermectin on Day 1.'}], 'classes': [{'title': 'Eradication by Day 2 (N = 30)', 'categories': [{'measurements': [{'value': '97', 'groupId': 'OG000'}]}]}, {'title': 'Eradication Maintained Through Day 8 and 15 (N=29)', 'categories': [{'measurements': [{'value': '86', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 2, Day 8 and Day 15 post-application', 'description': 'Eradication of live lice was assessed by visual examination of the scalp and hair before and following application of Ivermectin.', 'unitOfMeasure': 'Percent of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Eradication of live lice was assessed in the intent to treat population.'}, {'type': 'SECONDARY', 'title': 'Liver Function Test Results at Before (Day 1) and Following Ivermectin Application on Days 2, 8, and 15 Post-application', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '0.5% Ivermectin', 'description': 'Participants received a single application of 0.5% ivermectin on Day 1.'}], 'classes': [{'title': 'Alkaline Phosphatase - Day 1', 'categories': [{'measurements': [{'value': '257.9', 'spread': '59.5', 'groupId': 'OG000'}]}]}, {'title': 'Alkaline Phosphatase Day 2', 'categories': [{'measurements': [{'value': '258.0', 'spread': '58.4', 'groupId': 'OG000'}]}]}, {'title': 'Alkaline Phosphatase Change from Day 1 to 2', 'categories': [{'measurements': [{'value': '4.2', 'spread': '16.5', 'groupId': 'OG000'}]}]}, {'title': 'Alkaline Phosphatase Day 8', 'categories': [{'measurements': [{'value': '259.1', 'spread': '51.0', 'groupId': 'OG000'}]}]}, {'title': 'Alkaline Phosphatase Change from Day 1 to 8', 'categories': [{'measurements': [{'value': '-2.2', 'spread': '28.4', 'groupId': 'OG000'}]}]}, {'title': 'Alkaline Phosphatase Day 15', 'categories': [{'measurements': [{'value': '258.3', 'spread': '52.6', 'groupId': 'OG000'}]}]}, {'title': 'Alkaline Phosphatase Change from Day 1 to 15', 'categories': [{'measurements': [{'value': '-2.9', 'spread': '32.3', 'groupId': 'OG000'}]}]}, {'title': 'Alanine Aminotransferase Day 1', 'categories': [{'measurements': [{'value': '25.0', 'spread': '20.5', 'groupId': 'OG000'}]}]}, {'title': 'Alanine Aminotransferase Day 2', 'categories': [{'measurements': [{'value': '25.7', 'spread': '20.9', 'groupId': 'OG000'}]}]}, {'title': 'Alanine Aminotransferase Change from Day 1 to 2', 'categories': [{'measurements': [{'value': '0.2', 'spread': '20.9', 'groupId': 'OG000'}]}]}, {'title': 'Alanine Aminotransferase Day 8', 'categories': [{'measurements': [{'value': '25.1', 'spread': '22.1', 'groupId': 'OG000'}]}]}, {'title': 'Alanine Aminotransferase Change from Day 1 to 8', 'categories': [{'measurements': [{'value': '-0.2', 'spread': '5.3', 'groupId': 'OG000'}]}]}, {'title': 'Alanine Aminotransferase Day 15', 'categories': [{'measurements': [{'value': '24.1', 'spread': '15.5', 'groupId': 'OG000'}]}]}, {'title': 'Alanine Aminotransferase Change from Day 1 to 15', 'categories': [{'measurements': [{'value': '-1.1', 'spread': '8.9', 'groupId': 'OG000'}]}]}, {'title': 'Aspartate Aminotransferase Day 1', 'categories': [{'measurements': [{'value': '42.6', 'spread': '15.4', 'groupId': 'OG000'}]}]}, {'title': 'Aspartate Aminotransferase Day 2', 'categories': [{'measurements': [{'value': '41.1', 'spread': '11.5', 'groupId': 'OG000'}]}]}, {'title': 'Aspartate Aminotransferase Change from Day 1 to 2', 'categories': [{'measurements': [{'value': '-2.0', 'spread': '15.4', 'groupId': 'OG000'}]}]}, {'title': 'Aspartate Aminotransferase Day 8', 'categories': [{'measurements': [{'value': '40.3', 'spread': '14.0', 'groupId': 'OG000'}]}]}, {'title': 'Aspartate Aminotransferase Change from Day 1 to 8', 'categories': [{'measurements': [{'value': '-2.3', 'spread': '6.8', 'groupId': 'OG000'}]}]}, {'title': 'Aspartate Aminotransferase Day 15', 'categories': [{'measurements': [{'value': '39.5', 'spread': '9.6', 'groupId': 'OG000'}]}]}, {'title': 'Aspartate Aminotransferase Change from Day 1 to 15', 'categories': [{'measurements': [{'value': '-2.7', 'spread': '10.2', 'groupId': 'OG000'}]}]}, {'title': 'Lactate Dehydrogenase Day 1', 'categories': [{'measurements': [{'value': '308.0', 'spread': '87.5', 'groupId': 'OG000'}]}]}, {'title': 'Lactate Dehydrogenase Change Day 2', 'categories': [{'measurements': [{'value': '295.2', 'spread': '35.8', 'groupId': 'OG000'}]}]}, {'title': 'Lactate Dehydrogenase Change from Day 1 to 2', 'categories': [{'measurements': [{'value': '-16.8', 'spread': '95.1', 'groupId': 'OG000'}]}]}, {'title': 'Lactate Dehydrogenase Day 8', 'categories': [{'measurements': [{'value': '295.1', 'spread': '54.0', 'groupId': 'OG000'}]}]}, {'title': 'Lactate Dehydrogenase Change from Day 1 to 8', 'categories': [{'measurements': [{'value': '-10.7', 'spread': '80.2', 'groupId': 'OG000'}]}]}, {'title': 'Lactate Dehydrogenase 15', 'categories': [{'measurements': [{'value': '294.5', 'spread': '61.3', 'groupId': 'OG000'}]}]}, {'title': 'Lactate Dehydrogenase Change from Day 1 to 15', 'categories': [{'measurements': [{'value': '-9.2', 'spread': '69.0', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1, Day 2, Day 8 and Day 15 post-application', 'description': 'Liver function tests (Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, and Lactate Dehydrogenase) were performed before Ivermectin application on Day 1 (baseline) and on Days 2, 8, and 15 after application.', 'unitOfMeasure': 'U/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Liver function tests were performed in the intent to treat population.'}, {'type': 'SECONDARY', 'title': 'Liver Function Test Results at Before (Baseline) and Following Ivermectin Application on Days 2, 8, and 15 Post-application', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '0.5% Ivermectin', 'description': 'Participants received a single application of 0.5% ivermectin on Day 1.'}], 'classes': [{'title': 'Total Bilirubin - Day 1', 'categories': [{'measurements': [{'value': '0.3', 'spread': '0.3', 'groupId': 'OG000'}]}]}, {'title': 'Total Bilirubin Day 2', 'categories': [{'measurements': [{'value': '0.3', 'spread': '0.3', 'groupId': 'OG000'}]}]}, {'title': 'Total Bilirubin Change from Day 1 to 2', 'categories': [{'measurements': [{'value': '-0.0', 'spread': '0.1', 'groupId': 'OG000'}]}]}, {'title': 'Total Bilirubin Day 8', 'categories': [{'measurements': [{'value': '0.3', 'spread': '0.3', 'groupId': 'OG000'}]}]}, {'title': 'Total Bilirubin Change from Day 1 to 8', 'categories': [{'measurements': [{'value': '-0.0', 'spread': '0.1', 'groupId': 'OG000'}]}]}, {'title': 'Total Bilirubin Day 15', 'categories': [{'measurements': [{'value': '0.3', 'spread': '0.3', 'groupId': 'OG000'}]}]}, {'title': 'Total Bilirubin Change from Day 1 to 15', 'categories': [{'measurements': [{'value': '-0.1', 'spread': '0.2', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1, Day 2, Day 8 and Day 15 post-application', 'description': 'Liver function test (total bilirubin) was performed before treatment Day 1 (baseline) and following Ivermectin application on Days 2, 8, and 15 Post-application, respectively.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Liver function tests were performed in the intent to treat population.'}, {'type': 'PRIMARY', 'title': 'Summary of Pharmacokinetic Parameter (Mean Concentration) Following Ivermectin Application.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '0.5% Ivermectin', 'description': 'Participants received a single application of 0.5% ivermectin on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.241', 'spread': '0.23372', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Before; 0.5, 1, 6, 24 hours, Day 8 and Day 15 post-application', 'description': 'Plasma concentrations of ivermectin were measured by validated and appropriate bioanalytical instruments and methods before application and on Day 1 (0.5, 1, and 6 hours post-application), Day 2 (24 hours post-application), Day 8 (7 days post-application), and Day 15 (14 days post-application).', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Plasma concentrations of Ivermectin were assessed in the pharmacokinetic (PK) population.'}, {'type': 'PRIMARY', 'title': 'Summary of Pharmacokinetic Parameter (Time of Observed Maximum Plasma Concentration) Following Ivermectin Application.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '0.5% Ivermectin', 'description': 'Participants received a single application of 0.5% ivermectin on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '15.9', 'spread': '10', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Before; 0.5, 1, 6, 24 hours, Day 8 and Day 15 post-application', 'description': 'Plasma concentrations of ivermectin were measured by validated and appropriate bioanalytical instruments and methods before application and on Day 1 (0.5, 1, and 6 hours post-application), Day 2 (24 hours post-application), Day 8 (7 days post-application), and Day 15 (14 days post-application).', 'unitOfMeasure': 'hour', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Plasma concentrations of Ivermectin were assessed in the pharmacokinetic (PK) population.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '0.5% Ivermectin', 'description': 'Participants received a single application of 0.5% ivermectin on Day 1.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '27'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}]}], 'recruitmentDetails': 'Participants were enrolled and treated from 22 September 2009 to 18 November 2009 at 3 US clinical centers.', 'preAssignmentDetails': 'A total of 30 participants who met the inclusion and exclusion criteria were enrolled and treated.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': '0.5% Ivermectin', 'description': 'Participants received a single application of 0.5% ivermectin on Day 1.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '30', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '25.8', 'spread': '11.0', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Months', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '23', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-03', 'completionDateStruct': {'date': '2009-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-03-30', 'studyFirstSubmitDate': '2009-10-01', 'resultsFirstSubmitDate': '2012-03-01', 'studyFirstSubmitQcDate': '2009-10-01', 'lastUpdatePostDateStruct': {'date': '2012-04-25', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-03-30', 'studyFirstPostDateStruct': {'date': '2009-10-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-04-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Plasma Concentration of Ivermectin in Samples Collected Before Application and at Specified Post-Application Time Points', 'timeFrame': 'Before; 0.5, 1, 6, 24 hours and Up to 14 days post-application', 'description': 'Plasma concentrations of ivermectin were measured by validated and appropriate bioanalytical instruments and methods with a sensitivity of 0.05 ng/mL before application and on Day 1 (0.5, 1, and 6 hours), Day 2 (24 hours post-application), Day 8 (7 days post-application), and Day 15 (14 days post-application).'}, {'measure': 'Summary of Pharmacokinetic Parameters Following Ivermectin Application.', 'timeFrame': 'Before; 0.5, 1, 6, 24 hours, Day 8 and Day 15 post-application', 'description': 'Plasma concentrations of ivermectin were measured by validated and appropriate bioanalytical instruments and methods before application and on Day 1 (0.5, 1, and 6 hours post-application), Day 2 (24 hours post-application), Day 8 (7 days post-application), and Day 15 (14 days post-application).'}, {'measure': 'Summary of Pharmacokinetic Parameter (Mean Concentration) Following Ivermectin Application.', 'timeFrame': 'Before; 0.5, 1, 6, 24 hours, Day 8 and Day 15 post-application', 'description': 'Plasma concentrations of ivermectin were measured by validated and appropriate bioanalytical instruments and methods before application and on Day 1 (0.5, 1, and 6 hours post-application), Day 2 (24 hours post-application), Day 8 (7 days post-application), and Day 15 (14 days post-application).'}, {'measure': 'Summary of Pharmacokinetic Parameter (Time of Observed Maximum Plasma Concentration) Following Ivermectin Application.', 'timeFrame': 'Before; 0.5, 1, 6, 24 hours, Day 8 and Day 15 post-application', 'description': 'Plasma concentrations of ivermectin were measured by validated and appropriate bioanalytical instruments and methods before application and on Day 1 (0.5, 1, and 6 hours post-application), Day 2 (24 hours post-application), Day 8 (7 days post-application), and Day 15 (14 days post-application).'}], 'secondaryOutcomes': [{'measure': 'Number of Participants Reporting Adverse Events Following Ivermectin Treatment', 'timeFrame': 'Day 1 up Day 28 post-application', 'description': 'Adverse events were assessed at each visit and during the follow up phone call on Day 28.'}, {'measure': 'Percentage of Participants Who Were Lice-Free by Visit Post-treatment With Ivermectin.', 'timeFrame': 'Day 2, Day 8 and Day 15 post-application', 'description': 'Eradication of live lice was assessed by visual examination of the scalp and hair.'}, {'measure': 'Percentage of Participants Who Were Lice-Free by Day 2 That Were Maintained Through Day 8 and Day 15 Post-treatment With Ivermectin.', 'timeFrame': 'Day 2, Day 8 and Day 15 post-application', 'description': 'Eradication of live lice was assessed by visual examination of the scalp and hair before and following application of Ivermectin.'}, {'measure': 'Liver Function Test Results at Before (Day 1) and Following Ivermectin Application on Days 2, 8, and 15 Post-application', 'timeFrame': 'Day 1, Day 2, Day 8 and Day 15 post-application', 'description': 'Liver function tests (Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, and Lactate Dehydrogenase) were performed before Ivermectin application on Day 1 (baseline) and on Days 2, 8, and 15 after application.'}, {'measure': 'Liver Function Test Results at Before (Baseline) and Following Ivermectin Application on Days 2, 8, and 15 Post-application', 'timeFrame': 'Day 1, Day 2, Day 8 and Day 15 post-application', 'description': 'Liver function test (total bilirubin) was performed before treatment Day 1 (baseline) and following Ivermectin application on Days 2, 8, and 15 Post-application, respectively.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Head Lice', 'Pediculus'], 'conditions': ['Head Lice']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the bioavailability of 0.5% ivermectin cream in a pediatric population aged 6 months to 3 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '3 Years', 'minimumAge': '6 Months', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subject must be 6 months to 3 years of age, inclusive, when informed consent is signed.\n* Subject must be infested with head lice as demonstrated by the presence of at least 1 live louse prior to treatment.\n* Subject is in general good health.\n* Subject's parent/guardian (caregiver) must be willing and able to bring subject to all study visits as scheduled.\n* Subject's caregiver must have provided written informed consent (assent is not required due to the young age of the subjects).\n* Subject's caregiver must agree to comply with the following study restrictions:\n\n * will not use any other form of lice treatment (eg, commercial, community/anecdotal, or mechanical/manual) on the subject for the duration of the study, unless directed to do so by study personnel.\n * will not shampoo, wash, or rinse the subject's hair or scalp until the Day 2 treatment evaluation has been completed.\n * will not cut or chemically treat subject's hair in the period between screening and follow-up on Day 15.\n * will use only study-provided shampoo on the subject for the duration of the study.\n * will follow all study instructions.\n\nExclusion Criteria:\n\n* Subjects who have received any OTC or prescription treatment for head lice in the last 2 weeks.\n* Subjects or subjects' caregivers who are unable to comply with the study obligations and all study visits.\n* Subjects whose caregivers do not understand the requirements for participation and/or may be likely to exhibit poor compliance, in the opinion of the Investigator.\n* Subjects with eczema, atopic dermatitis, or other chronic conditions of the scalp and skin.\n* Subjects with visible skin/scalp condition(s) that are not attributable to head lice infestation, such as an erythema score that is \\> 2, blisters, or any other condition that, in the opinion of the investigative personnel or Sponsor, would interfere with the PK, safety and/or efficacy evaluations.\n* Subjects with a history of allergy to ivermectin or any ingredients commonly included in hair products such as shampoos, hair conditioners, or styling aids.\n* Subjects with other diagnoses that, in the opinion of the Investigator, would interfere with the PK, safety, and/or efficacy assessments or would preclude study participation.\n* Subjects who have been treated with a systemic antibiotic within 2 weeks before screening.\n* Subject currently taking warfarin sodium (Coumadin®) or has taken within 2 weeks before screening.\n* Subjects who have been enrolled in any clinical study within the past 30 days; subjects may not participate in another study while participating in this study."}, 'identificationModule': {'nctId': 'NCT00988533', 'briefTitle': 'A Pharmacokinetics (PK) Study in Lice Infested Children 6 Months to 3 Years of Age', 'organization': {'class': 'INDUSTRY', 'fullName': 'Topaz Pharmaceuticals Inc'}, 'officialTitle': 'An Open-label Study to Assess the Bioavailability, Safety, Local Tolerance, and Efficacy of 0.5% Ivermectin Cream in Subjects 6 Months to 3 Years of Age With Pediculus Humanus Capitis (Head Lice) Infestation', 'orgStudyIdInfo': {'id': 'TOP008'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '0.5% Ivermectin Cream', 'interventionNames': ['Drug: 0.5% Ivermectin Cream']}], 'interventions': [{'name': '0.5% Ivermectin Cream', 'type': 'DRUG', 'description': 'Topical 0.5% ivermectin cream applied to scalp and hair on day 1', 'armGroupLabels': ['0.5% Ivermectin Cream']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72712', 'city': 'Bentonville', 'state': 'Arkansas', 'country': 'United States', 'facility': "Children's Investigational Research Program", 'geoPoint': {'lat': 36.37285, 'lon': -94.20882}}, {'zip': '93618', 'city': 'Dinuba', 'state': 'California', 'country': 'United States', 'facility': 'Universal BioPharma Research, Inc', 'geoPoint': {'lat': 36.54328, 'lon': -119.38707}}, {'zip': '90036', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Impact Clinical Trials', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '33313', 'city': 'Plantation', 'state': 'Florida', 'country': 'United States', 'facility': 'Lice Source Solutions Inc', 'geoPoint': {'lat': 26.13421, 'lon': -80.23184}}, {'zip': '39466', 'city': 'Picayune', 'state': 'Mississippi', 'country': 'United States', 'facility': 'Spence Medical Research L.L.C', 'geoPoint': {'lat': 30.52556, 'lon': -89.67788}}], 'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sanofi Topaz'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Topaz Pharmaceuticals Inc', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}