Ignite Creation Date:
2025-12-24 @ 2:22 PM
Ignite Modification Date:
2026-01-03 @ 8:44 PM
Study NCT ID:
NCT00626795
Status:
COMPLETED
Last Update Posted:
2025-03-12
First Post:
2008-02-21
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy, Safety, and Tolerability of TD1414 2% Cream in Impetigo and Secondarily Infected Traumatic Lesions (SITL)
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016712', 'term': 'Mupirocin'}], 'ancestors': [{'id': 'D004852', 'term': 'Epoxy Compounds'}, {'id': 'D004988', 'term': 'Ethers, Cyclic'}, {'id': 'D004987', 'term': 'Ethers'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011714', 'term': 'Pyrans'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'disclosure@leo-pharma.com', 'phone': '+45 4494 5888', 'title': 'Clinical Trial Disclosure Manager', 'organization': 'LEO Pharma A/S'}, 'certainAgreement': {'otherDetails': "The Company acknowledges the investigators' right to publish the entire results of the study, irrespective of outcome. The Company retains the right to have any publication submitted to the Company for review at least 30 days prior to the same paper being submit-ted for publication or presentation. Investigators must undertake not to submit any part of their individual data for publication without the prior consent of LEO.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From Day 4 to Follow-up (Day 15) and Additional Follow-up (Day 14 after follow-up)', 'description': 'All patients assigned to open-label treatment who received at least one application of the study medication (TD1414) and for whom the presence or confirmed absence of adverse events was available were included in the open-label analysis set. All participants randomized to blinded treatment who received at least one application of study medication and for whom the presence or confirmed absence of adverse events was available were included in the safety analysis set and analyzed for safety.', 'eventGroups': [{'id': 'EG000', 'title': 'TD1414 TID >=16 Years', 'description': 'Open-label phase TD1414 2% cream: three times daily (TID) for 7 days', 'otherNumAtRisk': 17, 'otherNumAffected': 6, 'seriousNumAtRisk': 17, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'TD1414 TID >=12 to <16 Years', 'description': 'Open-label phase TD1414 2% cream: three times daily (TID) for 7 days', 'otherNumAtRisk': 16, 'otherNumAffected': 5, 'seriousNumAtRisk': 16, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'TD1414 TID >=6 to <12 Years', 'description': 'Open-label phase TD1414 2% cream: three times daily (TID) for 7 days', 'otherNumAtRisk': 16, 'otherNumAffected': 2, 'seriousNumAtRisk': 16, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'TD1414 TID >=2 to <6 Years', 'description': 'Open-label phase TD1414 2% cream: three times daily (TID) for 7 days', 'otherNumAtRisk': 16, 'otherNumAffected': 3, 'seriousNumAtRisk': 16, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'TD1414 BID', 'description': 'Blinded treatment TD1414 2% cream: two times daily (BID) for 7 days', 'otherNumAtRisk': 203, 'otherNumAffected': 61, 'seriousNumAtRisk': 203, 'seriousNumAffected': 2}, {'id': 'EG005', 'title': 'TD1414 TID', 'description': 'Blinded treatment TD1414 2% cream: three times daily (TID) for 7 days', 'otherNumAtRisk': 205, 'otherNumAffected': 49, 'seriousNumAtRisk': 205, 'seriousNumAffected': 2}, {'id': 'EG006', 'title': 'Bactroban® TID', 'description': 'Blinded treatment Bactroban® (mupirocin) 2% cream: three times daily (TID) for 7 days', 'otherNumAtRisk': 204, 'otherNumAffected': 34, 'seriousNumAtRisk': 204, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Lymphadenopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 205, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 204, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Aneamia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 203, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 205, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 204, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 205, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 204, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Lymphocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 205, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 204, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Long QT syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 203, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 205, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 204, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Eye pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 203, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 205, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 204, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Ocular hyperaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 203, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 205, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 204, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 205, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 204, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Umbilical hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 205, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 204, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Lip swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 203, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 205, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 204, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Application site irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 203, 'numAffected': 18}, {'groupId': 'EG005', 'numAtRisk': 205, 'numAffected': 16}, {'groupId': 'EG006', 'numAtRisk': 204, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Application site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 203, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 205, 'numAffected': 5}, {'groupId': 'EG006', 'numAtRisk': 204, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Application site pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 203, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 205, 'numAffected': 5}, {'groupId': 'EG006', 'numAtRisk': 204, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 205, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 204, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Treatment failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 205, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 204, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Application site swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 203, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 205, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 204, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Condition aggravated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 203, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 205, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 204, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Local swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 203, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 205, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 204, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 205, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 204, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Drug hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 203, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 205, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 204, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 203, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 205, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 204, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Impetigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 16, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 203, 'numAffected': 6}, {'groupId': 'EG005', 'numAtRisk': 205, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 204, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 203, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 205, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 204, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 203, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 205, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 204, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Acarodermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 205, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 204, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 205, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 204, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 203, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 205, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 204, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Oral herpes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 203, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 205, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 204, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Otitis media acute', 'stats': 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'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 205, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 204, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Dermatitis allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 203, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 205, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 204, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Rash maculo-papular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 203, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 205, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 204, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 203, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 205, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 204, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 203, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 205, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 204, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Hot flush', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 205, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 204, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 205, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 204, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 205, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 204, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Streptococcal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 205, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 204, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Tinea infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 205, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 204, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Wound infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 205, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 204, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Hepatic enzyme increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 205, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 204, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}], 'seriousEvents': [{'term': 'Pancytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 205, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 204, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Hyperthermia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 205, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 204, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 205, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 204, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Lower respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 205, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 204, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 205, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 204, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Penetrating abdominal trauma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 203, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 205, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 204, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Shunt occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 203, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 205, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 204, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Hypoglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 205, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 204, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Confusional state', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 205, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 204, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': "Participants With Clinical Cure According to Investigator's Assessment", 'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'OG000'}, {'value': '205', 'groupId': 'OG001'}, {'value': '204', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'TD1414 BID', 'description': 'TD1414 2% cream: two times daily (BID) for 7 days'}, {'id': 'OG001', 'title': 'TD1414 TID', 'description': 'TD1414 2% cream: three times daily (TID) for 7 days'}, {'id': 'OG002', 'title': 'Bactroban® TID', 'description': 'Bactroban® (mupirocin) 2% cream: three times daily (TID) for 7 days'}], 'classes': [{'categories': [{'title': 'Clinical cure', 'measurements': [{'value': '167', 'groupId': 'OG000'}, {'value': '184', 'groupId': 'OG001'}, {'value': '174', 'groupId': 'OG002'}]}, {'title': 'Clinical failure', 'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.56', 'ciLowerLimit': '-1.59', 'ciUpperLimit': '10.71', 'estimateComment': 'Estimated using a Cochran-Mantel-Haenszel approach, stratifying by country and disease (impetigo/SITL).', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'The lower confidence limit greater or equal to -12.5% indicates non-inferiority.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.35', 'ciLowerLimit': '-10.28', 'ciUpperLimit': '3.57', 'estimateComment': 'Estimated using a Cochran-Mantel-Haenszel approach, stratifying by country and disease (impetigo/SITL).', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'The lower confidence limit greater or equal to -12.5% indicates non-inferiority.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At end of treatment (Day 8)', 'description': "At end of treatment (Day 8), the participants had their impetigo/Secondarily Infected Traumatic Lesions (SITL) evaluated by the (sub)investigator.\n\nInvestigator's assessment of severity of infections (SIRS).\n\n* Exudates/pus\n* Crusting\n* Erythema\n* Oedema\n* Tissue Warmth\n* Itching\n* Pain\n\nEach sign/symptoms of infection was assessed by use of the following 4-point scale:\n\n* 0 = absent\n* 2 = mild\n* 4 = moderate\n* 6 = severe\n\nThe scores were summed up to a total SIRS score.\n\nClinical cure was either of the following:\n\n* Total absence of signs and symptoms of impetigo/SITL OR\n* Improvement - total SIRS score reduced to \\<8 and all individual clinical signs/symptoms included in the SIRS score should have been ≤4.\n\nClinical failure was either of the following:\n\n* Signs and symptoms of impetigo/SITL that did not meet the definition of clinical cure\n* Unable to determine (e.g. participants who refuse clinical examination or did not show at end of treatment or follow-up).", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants randomized to blinded treatment who received at least one application of study medication were included in the efficacy analysis. Two participants (one from TD1414 BID and one from Bactroban® TID) did not receive any study medication and are therefore not included.'}, {'type': 'SECONDARY', 'title': "Participants With Clinical Cure According to Investigator's Assessment", 'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'OG000'}, {'value': '205', 'groupId': 'OG001'}, {'value': '204', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'TD1414 BID', 'description': 'TD1414 2% cream: two times daily (BID) for 7 days'}, {'id': 'OG001', 'title': 'TD1414 TID', 'description': 'TD1414 2% cream: three times daily (TID) for 7 days'}, {'id': 'OG002', 'title': 'Bactroban® TID', 'description': 'Bactroban® (mupirocin) 2% cream: three times daily (TID) for 7 days'}], 'classes': [{'categories': [{'title': 'Clinical cure', 'measurements': [{'value': '173', 'groupId': 'OG000'}, {'value': '188', 'groupId': 'OG001'}, {'value': '185', 'groupId': 'OG002'}]}, {'title': 'Clinical failure', 'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At follow up (Day 15)', 'description': 'At follow up (Day 15), the participants had their impetigo/SITL evaluated by the (sub)investigator.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants randomized to blinded treatment who received at least one application of study medication were included in the efficacy analysis. Two participants (one from TD1414 BID and one from Bactroban® TID) did not receive any study medication and are therefore not included.'}, {'type': 'SECONDARY', 'title': "Participants With Clinical Cure According to Investigator's Assessment.", 'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'OG000'}, {'value': '205', 'groupId': 'OG001'}, {'value': '204', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'TD1414 BID', 'description': 'TD1414 2% cream: two times daily (BID) for 7 days'}, {'id': 'OG001', 'title': 'TD1414 TID', 'description': 'TD1414 2% cream: three times daily (TID) for 7 days'}, {'id': 'OG002', 'title': 'Bactroban® TID', 'description': 'Bactroban® (mupirocin) 2% cream: three times daily (TID) for 7 days'}], 'classes': [{'title': 'Clinical cure', 'categories': [{'measurements': [{'value': '158', 'groupId': 'OG000'}, {'value': '177', 'groupId': 'OG001'}, {'value': '166', 'groupId': 'OG002'}]}]}, {'title': 'Clinical failure', 'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At end of treatment (Day 8) and follow-up (Day 15)', 'description': 'At end of treatment (Day 8) and at follow-up (Day 15), the participants had their impetigo/SITL evaluated by the (sub)investigator.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants randomized to blinded treatment who received at least one application of study medication were included in the efficacy analysis. Two participants (one from TD1414 BID and one from Bactroban® TID) did not receive any study medication and are therefore not included.'}, {'type': 'SECONDARY', 'title': 'Participants With Bacteriological Cure According to Bacteriological Samples', 'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}, {'value': '118', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'TD1414 BID', 'description': 'TD1414 2% cream: two times daily (BID) for 7 days'}, {'id': 'OG001', 'title': 'TD1414 TID', 'description': 'TD1414 2% cream: three times daily (TID) for 7 days'}, {'id': 'OG002', 'title': 'Bactroban® TID', 'description': 'Bactroban® (mupirocin) 2% cream: three times daily (TID) for 7 days'}], 'classes': [{'title': 'End of treatment (Day 8)', 'categories': [{'title': 'Bacteriological cure', 'measurements': [{'value': '66', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}, {'value': '94', 'groupId': 'OG002'}]}, {'title': 'Bacteriological failure', 'measurements': [{'value': '44', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}]}]}, {'title': 'Follow-up (Day 15)', 'categories': [{'title': 'Bacteriological cure', 'measurements': [{'value': '74', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}, {'value': '102', 'groupId': 'OG002'}]}, {'title': 'Bacteriological failure', 'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}]}]}, {'title': 'End of Treatment and follow-up', 'categories': [{'title': 'Bacteriological cure', 'measurements': [{'value': '57', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}, {'value': '86', 'groupId': 'OG002'}]}, {'title': 'Bacteriological failure', 'measurements': [{'value': '53', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At end of treatment (Day 8), follow-up (Day 15) and end of treatment and follow-up', 'description': 'At baseline (Day 1), end of treatment (EOT), and follow-up (FU), the investigator obtained a bacteriological sample to base the assessment on.\n\nBacteriological cure was either of the following:\n\n* Eradication of the baseline pathogen.\n* Presumed eradication of the baseline pathogen\n* Infection with a pathogen different from the baseline pathogen at EOT or FU and the participant was NOT symptomatic.\n\nBacteriological failure was any of the following:\n\n* Documented lack of eradication of the baseline pathogen.\n* Documented relapse (re-infection) with the baseline pathogen\n* Documented super-infection, i.e. infection with a pathogen different from the baseline pathogen at EOT or FU, and the participants was symptomatic\n* Presumed persistence of baseline pathogen: Non-evaluable participants- participants who refused bacteriological examination or did not show at EOT or FU, and clinical failures who had no bacteriological sample to rule out bacterial infection.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Only the randomized participants that were infected with S. aureus or S. pyogenes at baseline were included in the analysis.'}, {'type': 'SECONDARY', 'title': "Participants With Clinical and Bacteriological Cure According to Investigator's Assessment and Bacteriological Samples", 'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}, {'value': '118', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'TD1414 BID', 'description': 'TD1414 2% cream: two times daily (BID) for 7 days'}, {'id': 'OG001', 'title': 'TD1414 TID', 'description': 'TD1414 2% cream: three times daily (TID) for 7 days'}, {'id': 'OG002', 'title': 'Bactroban® TID', 'description': 'Bactroban® (mupirocin) 2% cream: three times daily (TID) for 7 days'}], 'classes': [{'title': 'End of treatment (Day 8)', 'categories': [{'title': 'Clinical and bacteriological cure', 'measurements': [{'value': '59', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}, {'value': '88', 'groupId': 'OG002'}]}, {'title': 'Clinical or bacteriological failure', 'measurements': [{'value': '51', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}]}]}, {'title': 'Follow-up (Day 15)', 'categories': [{'title': 'Clinical and bacteriological cure', 'measurements': [{'value': '70', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}]}, {'title': 'Clinical or bacteriological failure', 'measurements': [{'value': '40', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}]}, {'title': 'End of Treatment and follow-up', 'categories': [{'title': 'Clinical and bacteriological cure', 'measurements': [{'value': '52', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}, {'value': '80', 'groupId': 'OG002'}]}, {'title': 'Clinical or bacteriological failure', 'measurements': [{'value': '58', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At end of treatment (Day 8), follow-up (Day 15) and end of treatment and follow-up', 'description': 'At end of treatment (Day 8) and at follow-up (Day 15) the participants had their impetigo/SITL evaluated by the (sub)investigator.\n\nAt baseline (Day 1), end of treatment (Day 8) and at follow-up (Day 15) the investigator obtained a bacteriological sample on which an assessment of bacteriological cure was based.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants randomized to blinded treatment who received at least one application of study medication and were infected with S. aureus or S. pyogenes at baseline were included in the analysis.'}, {'type': 'SECONDARY', 'title': "Participants With Clinical Cure According to Investigator's Assessment", 'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'OG000'}, {'value': '205', 'groupId': 'OG001'}, {'value': '204', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'TD1414 BID', 'description': 'TD1414 2% cream: two times daily (BID) for 7 days'}, {'id': 'OG001', 'title': 'TD1414 TID', 'description': 'TD1414 2% cream: three times daily (TID) for 7 days'}, {'id': 'OG002', 'title': 'Bactroban® TID', 'description': 'Bactroban® (mupirocin) 2% cream: three times daily (TID) for 7 days'}], 'classes': [{'categories': [{'title': 'Clinical cure', 'measurements': [{'value': '108', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}, {'value': '120', 'groupId': 'OG002'}]}, {'title': 'Clinical failure', 'measurements': [{'value': '95', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}, {'value': '84', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Day 4', 'description': 'At Day 4 the participants had their impetigo/SITL evaluated by the (sub)investigator.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants randomized to blinded treatment who received at least one application of study medication were included in the efficacy analysis. Two participants (one from TD1414 BID and one from Bactroban® TID) did not receive any study medication and are therefore not included.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'TD1414 BID', 'description': 'TD1414 2% cream: two times daily (BID) 7 days'}, {'id': 'FG001', 'title': 'TD1414 TID', 'description': 'TD1414 2% cream: three times daily (TID) 7 days'}, {'id': 'FG002', 'title': 'Bactroban® TID', 'description': 'Bactroban® (mupirocin) 2% cream: three times daily (TID) 7 days'}], 'periods': [{'title': 'Open-label TD1414 Cream TID Treatment', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '65'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '64'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}, {'title': 'Blinded Treatment', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '204'}, {'groupId': 'FG001', 'numSubjects': '205'}, {'groupId': 'FG002', 'numSubjects': '205'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '194'}, {'groupId': 'FG001', 'numSubjects': '200'}, {'groupId': 'FG002', 'numSubjects': '196'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '9'}]}], 'dropWithdraws': [{'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Unacceptable adverse event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Other reasons', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Missing reason for withdrawal', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '5'}]}]}], 'preAssignmentDetails': 'An open-label treatment consisting of one arm with 4 age groups of 16 participants treated with TD1414 cream three times daily was used in a stepwise inclusion, to detect major safety issues that could prevent the study from proceeding. The participants in the open-label phase were not included the efficacy analysis or in the randomized population'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '204', 'groupId': 'BG000'}, {'value': '205', 'groupId': 'BG001'}, {'value': '205', 'groupId': 'BG002'}, {'value': '614', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'TD1414 BID', 'description': 'TD1414 2% cream: two times daily (BID) 7 days'}, {'id': 'BG001', 'title': 'TD1414 TID', 'description': 'TD1414 2% cream: three times daily (TID) 7 days'}, {'id': 'BG002', 'title': 'Bactroban® TID', 'description': 'Bactroban® (mupirocin) 2% cream: three times daily (TID) 7 days'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'title': 'Participants assigned to open-label TD1414 TID', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '65', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '18.4', 'spread': '20.0', 'groupId': 'BG001'}, {'value': '18.4', 'spread': '20.0', 'groupId': 'BG003'}]}]}, {'title': 'Participants randomized to blinded treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '204', 'groupId': 'BG000'}, {'value': '205', 'groupId': 'BG001'}, {'value': '205', 'groupId': 'BG002'}, {'value': '614', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '38.6', 'spread': '14.8', 'groupId': 'BG000'}, {'value': '36.3', 'spread': '14.3', 'groupId': 'BG001'}, {'value': '38.3', 'spread': '15.3', 'groupId': 'BG002'}, {'value': '37.7', 'spread': '14.8', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': '65 participants were assigned to open-label TD1414 cream TID treatment for the purpose of safety evaluations.'}, {'title': 'Age, Customized', 'classes': [{'title': 'Participants assigned to open-label TD1414 TID', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '65', 'groupId': 'BG003'}]}], 'categories': [{'title': '≥16 years old', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}]}, {'title': '≥12 to <16 years old', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '16', 'groupId': 'BG003'}]}, {'title': '≥6 to <12 years old', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '16', 'groupId': 'BG003'}]}, {'title': '≥2 to <6 years old', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '16', 'groupId': 'BG003'}]}]}, {'title': 'Participants randomized to blinded treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '204', 'groupId': 'BG000'}, {'value': '205', 'groupId': 'BG001'}, {'value': '205', 'groupId': 'BG002'}, {'value': '614', 'groupId': 'BG003'}]}], 'categories': [{'title': '≥16 years old', 'measurements': [{'value': '193', 'groupId': 'BG000'}, {'value': '194', 'groupId': 'BG001'}, {'value': '195', 'groupId': 'BG002'}, {'value': '582', 'groupId': 'BG003'}]}, {'title': '≥12 to <16 years old', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '32', 'groupId': 'BG003'}]}, {'title': '≥6 to <12 years old', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': '≥2 to <6 years old', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': '65 participants were assigned to open-label TD1414 cream TID treatment for the purpose of safety evaluations.'}, {'title': 'Sex: Female, Male', 'classes': [{'title': 'Participants assigned to open-label TD1414 TID', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '65', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '35', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '30', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG003'}]}]}, {'title': 'Participants randomized to blinded treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '204', 'groupId': 'BG000'}, {'value': '205', 'groupId': 'BG001'}, {'value': '205', 'groupId': 'BG002'}, {'value': '614', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '97', 'groupId': 'BG000'}, {'value': '93', 'groupId': 'BG001'}, {'value': '110', 'groupId': 'BG002'}, {'value': '300', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '107', 'groupId': 'BG000'}, {'value': '112', 'groupId': 'BG001'}, {'value': '95', 'groupId': 'BG002'}, {'value': '314', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': '65 participants were assigned to open-label TD1414 cream TID treatment for the purpose of safety evaluations.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '204', 'groupId': 'BG000'}, {'value': '205', 'groupId': 'BG001'}, {'value': '205', 'groupId': 'BG002'}, {'value': '614', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '85', 'groupId': 'BG000'}, {'value': '79', 'groupId': 'BG001'}, {'value': '73', 'groupId': 'BG002'}, {'value': '237', 'groupId': 'BG003'}]}]}, {'title': 'South Africa', 'denoms': [{'units': 'Participants', 'counts': [{'value': '204', 'groupId': 'BG000'}, {'value': '205', 'groupId': 'BG001'}, {'value': '205', 'groupId': 'BG002'}, {'value': '614', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '119', 'groupId': 'BG000'}, {'value': '126', 'groupId': 'BG001'}, {'value': '132', 'groupId': 'BG002'}, {'value': '377', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 773}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-21', 'studyFirstSubmitDate': '2008-02-21', 'resultsFirstSubmitDate': '2018-06-26', 'studyFirstSubmitQcDate': '2008-02-21', 'lastUpdatePostDateStruct': {'date': '2025-03-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-06-26', 'studyFirstPostDateStruct': {'date': '2008-02-29', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-07-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Participants With Clinical Cure According to Investigator's Assessment", 'timeFrame': 'At end of treatment (Day 8)', 'description': "At end of treatment (Day 8), the participants had their impetigo/Secondarily Infected Traumatic Lesions (SITL) evaluated by the (sub)investigator.\n\nInvestigator's assessment of severity of infections (SIRS).\n\n* Exudates/pus\n* Crusting\n* Erythema\n* Oedema\n* Tissue Warmth\n* Itching\n* Pain\n\nEach sign/symptoms of infection was assessed by use of the following 4-point scale:\n\n* 0 = absent\n* 2 = mild\n* 4 = moderate\n* 6 = severe\n\nThe scores were summed up to a total SIRS score.\n\nClinical cure was either of the following:\n\n* Total absence of signs and symptoms of impetigo/SITL OR\n* Improvement - total SIRS score reduced to \\<8 and all individual clinical signs/symptoms included in the SIRS score should have been ≤4.\n\nClinical failure was either of the following:\n\n* Signs and symptoms of impetigo/SITL that did not meet the definition of clinical cure\n* Unable to determine (e.g. participants who refuse clinical examination or did not show at end of treatment or follow-up)."}], 'secondaryOutcomes': [{'measure': "Participants With Clinical Cure According to Investigator's Assessment", 'timeFrame': 'At follow up (Day 15)', 'description': 'At follow up (Day 15), the participants had their impetigo/SITL evaluated by the (sub)investigator.'}, {'measure': "Participants With Clinical Cure According to Investigator's Assessment.", 'timeFrame': 'At end of treatment (Day 8) and follow-up (Day 15)', 'description': 'At end of treatment (Day 8) and at follow-up (Day 15), the participants had their impetigo/SITL evaluated by the (sub)investigator.'}, {'measure': 'Participants With Bacteriological Cure According to Bacteriological Samples', 'timeFrame': 'At end of treatment (Day 8), follow-up (Day 15) and end of treatment and follow-up', 'description': 'At baseline (Day 1), end of treatment (EOT), and follow-up (FU), the investigator obtained a bacteriological sample to base the assessment on.\n\nBacteriological cure was either of the following:\n\n* Eradication of the baseline pathogen.\n* Presumed eradication of the baseline pathogen\n* Infection with a pathogen different from the baseline pathogen at EOT or FU and the participant was NOT symptomatic.\n\nBacteriological failure was any of the following:\n\n* Documented lack of eradication of the baseline pathogen.\n* Documented relapse (re-infection) with the baseline pathogen\n* Documented super-infection, i.e. infection with a pathogen different from the baseline pathogen at EOT or FU, and the participants was symptomatic\n* Presumed persistence of baseline pathogen: Non-evaluable participants- participants who refused bacteriological examination or did not show at EOT or FU, and clinical failures who had no bacteriological sample to rule out bacterial infection.'}, {'measure': "Participants With Clinical and Bacteriological Cure According to Investigator's Assessment and Bacteriological Samples", 'timeFrame': 'At end of treatment (Day 8), follow-up (Day 15) and end of treatment and follow-up', 'description': 'At end of treatment (Day 8) and at follow-up (Day 15) the participants had their impetigo/SITL evaluated by the (sub)investigator.\n\nAt baseline (Day 1), end of treatment (Day 8) and at follow-up (Day 15) the investigator obtained a bacteriological sample on which an assessment of bacteriological cure was based.'}, {'measure': "Participants With Clinical Cure According to Investigator's Assessment", 'timeFrame': 'At Day 4', 'description': 'At Day 4 the participants had their impetigo/SITL evaluated by the (sub)investigator.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Impetigo', 'Secondarily Infected Traumatic Lesions']}, 'descriptionModule': {'briefSummary': 'An international, multi-centre, prospective three arm parallel-group, phase II proof of concept study comparing the efficacy and safety of two dosage regimens (BID 7 days and TID 7 days) of TD1414 2% cream and one dosage regimen (BID 7 days) of Bactroban® (mupirocin) 2% cream in adults and children down to 2 years of age with impetigo or SITL. Furthermore an evaluation of the pharmacokinetics of TD1414 2% cream TID for 7 days will be performed. A total of 664 patients will be enrolled in a stepwise manner according to age groups starting with the oldest age group.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Signed and dated informed consent from patient and/or legally acceptable representative has been obtained\n* Outpatients of any sex or ethnic origin\n* Patients \\>= 2 years of age (depending on study step)\n* Patients must be suffering from primary bullous/non-bullous impetigo or SITL\n\nExclusion Criteria:\n\n* Presence of skin diseases at or near the investigational area\n* Immunosuppressed state or other serious systemic disease\n* Signs and/or symptoms of systemic infection\n* Presence of skin infection/disorder not amenable to topical antibacterial treatment only\n* Presence of secondarily-infected animal/human bite\n* Presence of secondarily infected burnwound\n* Topical or systemic use of medicinal or other products before or during the study which in the investigators opinion could confound the evaluation of the effect of the study drugs\n* Known or suspected hypersensitivity to TD1414 or any of the excipients in the TD1414 2% cream\n* Known or suspected hypersensitivity to mupirocin or any of the excipients in the Bactroban® (mupirocin) 2% cream\n* Participation in any other investigational drug study or use of (an) investigational drug(s) within the 30 days or 5 half-lives (whichever is longer) prior to randomisation\n* Patients previously enrolled/randomised in this study\n* Abnormal ECG at baseline though the PR interval may be up to 220 ms, the QRS interval up to 110 ms and the QTc interval up to 450 ms'}, 'identificationModule': {'nctId': 'NCT00626795', 'briefTitle': 'Efficacy, Safety, and Tolerability of TD1414 2% Cream in Impetigo and Secondarily Infected Traumatic Lesions (SITL)', 'organization': {'class': 'INDUSTRY', 'fullName': 'LEO Pharma'}, 'officialTitle': 'Efficacy, Safety and Tolerability of TD1414 2% Cream in Impetigo and Secondarily Infected Traumatic Lesions (SITL)', 'orgStudyIdInfo': {'id': 'TD1414-C21'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Drug: TD1414 2% cream']}, {'type': 'EXPERIMENTAL', 'label': '2', 'interventionNames': ['Drug: TD1414 2% cream']}, {'type': 'ACTIVE_COMPARATOR', 'label': '3', 'interventionNames': ['Drug: Bactroban® (mupirocin) 2% cream']}], 'interventions': [{'name': 'TD1414 2% cream', 'type': 'DRUG', 'description': 'BID 7 days', 'armGroupLabels': ['1']}, {'name': 'TD1414 2% cream', 'type': 'DRUG', 'description': 'TID 7 days', 'armGroupLabels': ['2']}, {'name': 'Bactroban® (mupirocin) 2% cream', 'type': 'DRUG', 'description': 'BID 7 days', 'armGroupLabels': ['3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '36207', 'city': 'Anniston', 'state': 'Alabama', 'country': 'United States', 'facility': 'Anniston Medical Clinic', 'geoPoint': {'lat': 33.65983, 'lon': -85.83163}}, {'zip': '7925', 'city': 'Cape Town', 'state': 'Western Cape', 'country': 'South Africa', 'facility': 'Division of Dermatology, Groote Schuur Hospital, G23', 'geoPoint': {'lat': -33.92584, 'lon': 18.42322}}], 'overallOfficials': [{'name': 'Almena L Free, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Anniston Medical Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'LEO Pharma', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}