Ignite Creation Date:
2025-12-24 @ 11:35 PM
Ignite Modification Date:
2026-02-17 @ 3:25 PM
Study NCT ID:
NCT00986856
Status:
TERMINATED
Last Update Posted:
2025-03-06
First Post:
2009-09-29
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Fucidin® Cream in the Treatment of Impetigo
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007169', 'term': 'Impetigo'}], 'ancestors': [{'id': 'D013207', 'term': 'Staphylococcal Skin Infections'}, {'id': 'D013203', 'term': 'Staphylococcal Infections'}, {'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D013290', 'term': 'Streptococcal Infections'}, {'id': 'D017192', 'term': 'Skin Diseases, Bacterial'}, {'id': 'D012874', 'term': 'Skin Diseases, Infectious'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'anders.larsen@leo-pharma.com', 'phone': '+45 72262990', 'title': 'Anders Rhod Larsen, Scientific advisor', 'organization': 'LEO Pharma'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'It was planned to Incl. 360 Pts(Proport.3:1 Fucidin® cream:Fucidin® cream vehicle), but due to very slow recruitment in SE and N and inability to Incl. UK, only 59 Pts were enrolled. 58 Pts were randomised: 42Fucidin® cream:16 Fucidin® cream vehicle.'}}, 'adverseEventsModule': {'description': 'All 58 randomised patients comprised the safety analysis set except patients who: 1. did not provide any post randomisation safety data or 2. did not use any trial medication confirmed by return of all trial medication given to the patients.', 'eventGroups': [{'id': 'EG000', 'title': 'Fucidin® Cream', 'description': 'Fucidin® cream 20 mg/g 3 times daily for 10 days', 'otherNumAtRisk': 40, 'otherNumAffected': 5, 'seriousNumAtRisk': 40, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Fucidin® Cream Vehicle', 'description': 'Fucidin® cream vehicle 3 times daily for 10 days', 'otherNumAtRisk': 16, 'otherNumAffected': 4, 'seriousNumAtRisk': 16, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Gastrointestinal disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Infections and infestations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Infections and', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Patients With Clinical Success (Marked Improvement or Completely Cleared) and Bacteriological Success (Eradication) at End of Treatment (EOT).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fucidin® Cream', 'description': 'Fucidin® cream 20 mg/g 3 times daily for 10 days'}, {'id': 'OG001', 'title': 'Fucidin® Cream Vehicle', 'description': 'Fucidin® cream vehicle 3 times daily for 10 days'}], 'classes': [{'title': 'Clinical and bacteriological success', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Clinical and bacteriological failure', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.01', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciPctValue': '95', 'paramValue': '13.2', 'ciLowerLimit': '1.4', 'ciUpperLimit': '120.4', 'pValueComment': 'Test for the hypothesis of odds ratio equal to 1.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': 'EOT: Visit at Day 25', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population was the full (intention-to treat) analysis set including the patients with confirmed presence of pathogenic bacteria (S. aureus and/or betahaemolytic streptococci (group A)) at baseline', 'anticipatedPostingDate': '2009-12'}, {'type': 'SECONDARY', 'title': 'Number of Patients With Clinical Success at Visit 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fucidin® Cream', 'description': 'Fucidin® cream 20 mg/g 3 times daily for 10 days'}, {'id': 'OG001', 'title': 'Fucidin® Cream Vehicle', 'description': 'Fucidin® cream vehicle 3 times daily for 10 days'}], 'classes': [{'title': 'Success', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Failure', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.023', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciPctValue': '95', 'paramValue': '5.7', 'ciLowerLimit': '1.1', 'ciUpperLimit': '28.6', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': 'Visit 2: Day 4', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set consists of 56 patients, 40 patients in the Fucidin® cream 20 mg/g group and 16 patients in the Fucidin® cream vehicle group (2 patients excluded because of lack of efficacy data)', 'anticipatedPostingDate': '2009-12'}, {'type': 'SECONDARY', 'title': 'Number of Patients With Clinical Success at Visit 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fucidin® Cream', 'description': 'Fucidin® cream 20 mg/g 3 times daily for 10 days'}, {'id': 'OG001', 'title': 'Fucidin® Cream Vehicle', 'description': 'Fucidin® cream vehicle 3 times daily for 10 days'}], 'classes': [{'title': 'Success', 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Failure', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.54', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.7', 'ciLowerLimit': '0.3', 'ciUpperLimit': '8.1', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': 'Visit 3: Day 11', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population were those patients who had a visit 3 observation'}, {'type': 'SECONDARY', 'title': 'Number of Patients With Clinical Success at EOT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fucidin® Cream', 'description': 'Fucidin® cream 20 mg/g 3 times daily for 10 days'}, {'id': 'OG001', 'title': 'Fucidin® Cream Vehicle', 'description': 'Fucidin® cream vehicle 3 times daily for 10 days'}], 'classes': [{'title': 'Success', 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Failure', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.1', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.7', 'ciLowerLimit': '0.8', 'ciUpperLimit': '8.8', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': 'EOT: Visit at day 25', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set consists of 56 patients, 40 patients in the Fucidin® cream 20 mg/g group and 16 patients in the Fucidin® cream vehicle group (2 patients excluded because of lack of efficacy data)'}, {'type': 'SECONDARY', 'title': 'Number of Patients With Bacteriological Success at Visit 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fucidin® Cream', 'description': 'Fucidin® cream 20 mg/g 3 times daily for 10 days'}, {'id': 'OG001', 'title': 'Fucidin® Cream Vehicle', 'description': 'Fucidin® cream vehicle 3 times daily for 10 days'}], 'classes': [{'title': 'Success', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Failure', 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.1', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': 'Visit 2: Day 4', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population was the full (intention-to treat) analysis set including the patients with confirmed presence of pathogenic bacteria (S. aureus and/or betahaemolytic streptococci (group A)) at baseline', 'anticipatedPostingDate': '2009-12'}, {'type': 'SECONDARY', 'title': 'Number of Patients With Bacteriological Success at Visit 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fucidin® Cream', 'description': 'Fucidin® cream 20 mg/g 3 times daily for 10 days'}, {'id': 'OG001', 'title': 'Fucidin® Cream Vehicle', 'description': 'Fucidin® cream vehicle 3 times daily for 10 days'}], 'classes': [{'title': 'Success', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Failure', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.043', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '8.5', 'ciLowerLimit': '0.9', 'ciUpperLimit': '83.5', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': 'Visit 3: Day 11', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population were those patients who had a visit 3 observation', 'anticipatedPostingDate': '2009-12'}, {'type': 'SECONDARY', 'title': 'Number of Patients With Bacteriological Success at EOT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fucidin® Cream', 'description': 'Fucidin® cream 20 mg/g 3 times daily for 10 days'}, {'id': 'OG001', 'title': 'Fucidin® Cream Vehicle', 'description': 'Fucidin® cream vehicle 3 times daily for 10 days'}], 'classes': [{'title': 'Success', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Failure', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.007', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciPctValue': '95', 'paramValue': '12.8', 'ciLowerLimit': '1.5', 'ciUpperLimit': '109.6', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': 'EOT: Visit at day 25', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population was the full (intention-to treat) analysis set including the patients with confirmed presence of pathogenic bacteria (S. aureus and/or betahaemolytic streptococci (group A)) at baseline', 'anticipatedPostingDate': '2009-12'}, {'type': 'SECONDARY', 'title': 'The Actual Change in Total Severity Score From Baseline to End of Treatment (LOCF).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fucidin® Cream', 'description': 'Fucidin® cream 20 mg/g 3 times daily for 10 days'}, {'id': 'OG001', 'title': 'Fucidin® Cream Vehicle', 'description': 'Fucidin® cream vehicle 3 times daily for 10 days'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.9', 'spread': '3.5', 'groupId': 'OG000'}, {'value': '-1.2', 'spread': '4.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.008', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-2.8', 'ciLowerLimit': '-4.8', 'ciUpperLimit': '-0.8', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '2', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': 'EOT: Visit at day 25', 'description': 'Total Severity Score is the sum of scores for the following 5 signs: Pustules/infected bullae, erythema, infiltration/induration, erosions and crusting. Each sign is assessed using a 4-point scale: 0=absent, 1=mild, 2=moderate and 3=severe involvement. Minimum Total Severity score is 0, maximum score is 15.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set consists of 56 patients, 40 patients in the Fucidin® cream 20 mg/g group and 16 patients in the Fucidin® cream vehicle group (2 patients excluded because of lack of efficacy data)', 'anticipatedPostingDate': '2009-12'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Fucidin® Cream', 'description': 'Fucidin® cream 20 mg/g 3 times daily for 10 days'}, {'id': 'FG001', 'title': 'Fucidin® Cream Vehicle', 'description': 'Fucidin® cream vehicle 3 times daily for 10 days'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '42'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '42'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Fucidin® Cream', 'description': 'Fucidin® cream 20 mg/g 3 times daily for 10 days'}, {'id': 'BG001', 'title': 'Fucidin® Cream Vehicle', 'description': 'Fucidin® cream vehicle 3 times daily for 10 days'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '42', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '4.8', 'spread': '2.7', 'groupId': 'BG000'}, {'value': '6.3', 'spread': '2.9', 'groupId': 'BG001'}, {'value': '5.2', 'spread': '2.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Sweden', 'categories': [{'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}]}]}, {'title': 'Norway', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'S.aureus susceptible to fusidic acid', 'classes': [{'title': 'S. aureus susceptible to fusidic acid', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}, {'title': 'S. aureus resistant to fusidic acid', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}]}, {'title': 'No S. aureus isolated', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'S. aureus'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 58}}, 'statusModule': {'whyStopped': 'Enrollment failed', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2004-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2005-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-21', 'studyFirstSubmitDate': '2009-09-29', 'resultsFirstSubmitDate': '2010-03-19', 'studyFirstSubmitQcDate': '2009-09-29', 'lastUpdatePostDateStruct': {'date': '2025-03-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2010-09-07', 'studyFirstPostDateStruct': {'date': '2009-09-30', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-09-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Patients With Clinical Success (Marked Improvement or Completely Cleared) and Bacteriological Success (Eradication) at End of Treatment (EOT).', 'timeFrame': 'EOT: Visit at Day 25'}], 'secondaryOutcomes': [{'measure': 'Number of Patients With Clinical Success at Visit 2', 'timeFrame': 'Visit 2: Day 4'}, {'measure': 'Number of Patients With Clinical Success at Visit 3', 'timeFrame': 'Visit 3: Day 11'}, {'measure': 'Number of Patients With Clinical Success at EOT', 'timeFrame': 'EOT: Visit at day 25'}, {'measure': 'Number of Patients With Bacteriological Success at Visit 2', 'timeFrame': 'Visit 2: Day 4'}, {'measure': 'Number of Patients With Bacteriological Success at Visit 3', 'timeFrame': 'Visit 3: Day 11'}, {'measure': 'Number of Patients With Bacteriological Success at EOT', 'timeFrame': 'EOT: Visit at day 25'}, {'measure': 'The Actual Change in Total Severity Score From Baseline to End of Treatment (LOCF).', 'timeFrame': 'EOT: Visit at day 25', 'description': 'Total Severity Score is the sum of scores for the following 5 signs: Pustules/infected bullae, erythema, infiltration/induration, erosions and crusting. Each sign is assessed using a 4-point scale: 0=absent, 1=mild, 2=moderate and 3=severe involvement. Minimum Total Severity score is 0, maximum score is 15.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Impetigo']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.leopharmatrials.com/en', 'label': 'Clinical Trials at LEO Pharma'}]}, 'descriptionModule': {'briefSummary': 'To investigate the clinical and bacteriological efficacy of Fucidin® cream in the treatment of impetigo in paediatric patients.\n\nTo assess the validity of in vitro susceptibility-testing of S. aureus to fusidic acid as a prediction of clinical and bacteriological outcome in impetigo patients treated with Fucidin® cream.\n\nTo investigate the genetic relationship between S. aureus-strains isolated from impetigo patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '11 Years', 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with a clinical diagnosis of impetigo,\n* Patients aged 2-11 years,\n* Patients of either sex,\n* Patients whose parent(s) has(ve) provided written consent, AND\n* Patients with a severity score of 1 for at least one of the following signs: pustules/infected bullae, erythema and infiltration/induration.\n\nExclusion Criteria:\n\n* Patients with other active inflammatory dermatitis at the area of impetigo,\n* Patients with a temperature above 38.5 C rectally (or equivalent), OR\n* Patients who have been administered topical or systemic Fucidin® or other antibacterial agents within the previous 4 weeks.'}, 'identificationModule': {'nctId': 'NCT00986856', 'briefTitle': 'Fucidin® Cream in the Treatment of Impetigo', 'organization': {'class': 'INDUSTRY', 'fullName': 'LEO Pharma'}, 'officialTitle': 'A Phase IV Study Comparing Clinical and Bacteriological Efficacy of Fucidin® Cream With Fucidin® Cream Vehicle in the Treatment of Impetigo in Paediatric Patients', 'orgStudyIdInfo': {'id': 'FUC 0301 INT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Fucidin® cream', 'interventionNames': ['Drug: Fucidin® cream']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Fucidin® cream vehicle', 'interventionNames': ['Drug: Fucidin® cream']}], 'interventions': [{'name': 'Fucidin® cream', 'type': 'DRUG', 'armGroupLabels': ['Fucidin® cream', 'Fucidin® cream vehicle']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5021', 'city': 'Bergen', 'country': 'Norway', 'facility': 'Institute of Internal Medicin, Haukeland University Hospital', 'geoPoint': {'lat': 60.39299, 'lon': 5.32415}}, {'zip': '411 19', 'city': 'Gothenburg', 'country': 'Sweden', 'facility': 'Vårdcentrum Kungshöjd', 'geoPoint': {'lat': 57.70716, 'lon': 11.96679}}], 'overallOfficials': [{'name': 'Medical Expert', 'role': 'STUDY_DIRECTOR', 'affiliation': 'LEO Pharma'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'LEO Pharma', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Pontus Hegardt, Clinical Trial Manager', 'oldOrganization': 'LEO Pharma'}}}}