Ignite Creation Date:
2025-12-24 @ 11:52 AM
Ignite Modification Date:
2026-01-01 @ 12:44 PM
Study NCT ID:
NCT01397461
Status:
COMPLETED
Last Update Posted:
2016-07-01
First Post:
2011-07-12
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy and Safety of Ozenoxacin 1% Cream Versus Placebo in the Treatment of Patients With 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C508887', 'term': 'retapamulin'}, {'id': 'D009824', 'term': 'Ointments'}, {'id': 'C000592413', 'term': 'ozenoxacin'}], 'ancestors': [{'id': 'D004304', 'term': 'Dosage Forms'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'nalbareda@ferrer.com', 'phone': '+34 93 509 32 75', 'title': 'Clinical Research Manager', 'organization': 'Ferrer Internacional, S.A.'}, 'certainAgreement': {'otherDetails': 'Any and all data resulting from the Study will not be presented or published in any form or media by the Institution, Investigator or Research Staff without the prior written consent of Sponsor which consent maybe as directed within the Protocol.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'AEs were elicited from signing the informed consent to the completion of the clinical study (including the Final Visit) or premature patient withdrawal from the study (10-13 days)', 'description': 'The safety population was defined as all patients who had at least one application of study drug.\n\nOne patient was randomised to retapamulin but treated with ozenoxacin. One patient was randomised to retapamulin but not treated.', 'eventGroups': [{'id': 'EG000', 'title': 'Ozenoxacin 1% Cream', 'description': '1% cream\n\nozenoxacin 1% cream: 1% cream', 'otherNumAtRisk': 156, 'otherNumAffected': 0, 'seriousNumAtRisk': 156, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Ozenoxacin Placebo', 'description': 'cream\n\nozenoxacin placebo: cream', 'otherNumAtRisk': 156, 'otherNumAffected': 0, 'seriousNumAtRisk': 156, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Retapamulin 1% Ointment', 'description': '1% ointment\n\nretapamulin 1% ointment: ointment', 'otherNumAtRisk': 152, 'otherNumAffected': 0, 'seriousNumAtRisk': 152, 'seriousNumAffected': 0}], 'frequencyThreshold': '3'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Clinical Success', 'denoms': [{'units': 'Participants', 'counts': [{'value': '155', 'groupId': 'OG000'}, {'value': '156', 'groupId': 'OG001'}, {'value': '154', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ozenoxacin 1% Cream', 'description': '1% cream\n\nozenoxacin 1% cream: 1% cream'}, {'id': 'OG001', 'title': 'Ozenoxacin Placebo', 'description': 'cream\n\nozenoxacin placebo: cream'}, {'id': 'OG002', 'title': 'Retapamulin 1% Ointment', 'description': '1% ointment\n\nretapamulin 1% ointment: ointment'}], 'classes': [{'categories': [{'measurements': [{'value': '34.8', 'groupId': 'OG000'}, {'value': '19.2', 'groupId': 'OG001'}, {'value': '37.7', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.003', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'The treatment comparison was done using only the outcomes of Clinical success and Clinical failure. The p value of the chi square test (without continuity correction) and corresponding 95% asymptotic (Wald) CI for the difference in success rates for the ozenoxacin versus placebo were provided. The analysis was performed to test the superiority of ozenoxacin versus placebo.\n\nText extracted from the statistical analysis plan. No additional data was pre-specified for the statistical comparison', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '2 weeks', 'description': 'Clinical response (clinical success or clinical failure) at end of therapy (Visit 3) in the intent to treat clinical (ITTC) population.\n\nClinical succes at Visit 3 was defined as: SIRS score 0 for exudates/pus, crusting, tissue warmth and pain and no more than 1 each for erythema/inflammation, tissue edema and itching such that no additional antimicrobial therapy in the baseline (Visit 1) affected area is necessary.\n\nThe SIRS is a severity index based on seven signs or symptoms:\n\n* Exudate/pus\n* Crusting\n* Erythema/inflammation\n* Tissue warmth\n* Tissue oedema\n* Itching\n* Pain\n\nEach sign/symptom is rated on a scale from 0 to 6:\n\n0 = absent\n\n1 2 = mild 3 4 = moderate 5 6 = severe', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Ozenoxacin 1% Cream', 'description': '1% cream\n\nozenoxacin 1% cream: 1% cream'}, {'id': 'FG001', 'title': 'Ozenoxacin Placebo', 'description': 'cream\n\nozenoxacin placebo: cream'}, {'id': 'FG002', 'title': 'Retapamulin 1% Ointment', 'description': '1% ointment\n\nretapamulin 1% ointment: ointment'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '155'}, {'groupId': 'FG001', 'numSubjects': '156'}, {'groupId': 'FG002', 'numSubjects': '154'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '153'}, {'groupId': 'FG001', 'numSubjects': '150'}, {'groupId': 'FG002', 'numSubjects': '152'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Not treated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Patients were enrolled at 27 sites in the USA, Germany, Romania, Ukraine, and South Africa.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '156', 'groupId': 'BG000'}, {'value': '156', 'groupId': 'BG001'}, {'value': '152', 'groupId': 'BG002'}, {'value': '464', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Ozenoxacin 1% Cream', 'description': '1% cream\n\nozenoxacin 1% cream: 1% cream'}, {'id': 'BG001', 'title': 'Ozenoxacin Placebo', 'description': 'cream\n\nozenoxacin placebo: cream'}, {'id': 'BG002', 'title': 'Retapamulin 1% Ointment', 'description': '1% ointment\n\nretapamulin 1% ointment: ointment'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '2>=years to <12 years', 'categories': [{'measurements': [{'value': '95', 'groupId': 'BG000'}, {'value': '94', 'groupId': 'BG001'}, {'value': '94', 'groupId': 'BG002'}, {'value': '283', 'groupId': 'BG003'}]}]}, {'title': '>=12 years to <18 years', 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '52', 'groupId': 'BG003'}]}]}, {'title': '>=18 years to <65 years', 'categories': [{'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}, {'value': '116', 'groupId': 'BG003'}]}]}, {'title': '>=65', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '56', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}, {'value': '178', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '100', 'groupId': 'BG000'}, {'value': '96', 'groupId': 'BG001'}, {'value': '90', 'groupId': 'BG002'}, {'value': '286', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Black or African American', 'categories': [{'measurements': [{'value': '78', 'groupId': 'BG000'}, {'value': '77', 'groupId': 'BG001'}, {'value': '78', 'groupId': 'BG002'}, {'value': '233', 'groupId': 'BG003'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '58', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}, {'value': '170', 'groupId': 'BG003'}]}]}, {'title': 'Mixed race', 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}, {'value': '56', 'groupId': 'BG003'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}]}, {'title': 'American Indian or Alaska native', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The baseline analysis population was considered the safety populations. The safety population was defined as all patients who had at least one application of study drug.\n\nOne patient was randomised to retapamulin but treated with ozenoxacin. One patient was randomised to retapamulin but not treated.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 465}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-06', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-06-01', 'studyFirstSubmitDate': '2011-07-12', 'resultsFirstSubmitDate': '2016-02-25', 'studyFirstSubmitQcDate': '2011-07-18', 'lastUpdatePostDateStruct': {'date': '2016-07-01', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-04-12', 'studyFirstPostDateStruct': {'date': '2011-07-19', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-05-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical Success', 'timeFrame': '2 weeks', 'description': 'Clinical response (clinical success or clinical failure) at end of therapy (Visit 3) in the intent to treat clinical (ITTC) population.\n\nClinical succes at Visit 3 was defined as: SIRS score 0 for exudates/pus, crusting, tissue warmth and pain and no more than 1 each for erythema/inflammation, tissue edema and itching such that no additional antimicrobial therapy in the baseline (Visit 1) affected area is necessary.\n\nThe SIRS is a severity index based on seven signs or symptoms:\n\n* Exudate/pus\n* Crusting\n* Erythema/inflammation\n* Tissue warmth\n* Tissue oedema\n* Itching\n* Pain\n\nEach sign/symptom is rated on a scale from 0 to 6:\n\n0 = absent\n\n1 2 = mild 3 4 = moderate 5 6 = severe'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Impetigo']}, 'referencesModule': {'references': [{'pmid': '30365584', 'type': 'DERIVED', 'citation': 'Hebert AA, Albareda N, Rosen T, Torrelo A, Grimalt R, Rosenberg N, Zsolt I, Masramon X. Topical Antibacterial Agent for Treatment of Adult and Pediatric Patients With Impetigo: Pooled Analysis of Phase 3 Clinical Trials. J Drugs Dermatol. 2018 Oct 1;17(10):1051-1057.'}]}, 'descriptionModule': {'briefSummary': 'This is multicenter, randomised, placebo controlled, parallel, blinded (double-blind for ozenoxacin versus placebo comparison and investigator blinded for retapamulin versus placebo comparison), superiority clinical study comparing ozenoxacin cream versus placebo and retapamulin ointment vs placebo, in patients with a clinical diagnosis of non-bullous or bullous impetigo.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical diagnosis of bullous or non bullous impetigo. The patient has a total affected area comprised between 1-100 cm2 with surrounding erythema not extending more than 2 cm from the edge of any affected area. In case of multiple affected areas the total area will be the sum of each affected area and will not exceed 100 cm2. Additionally for patients \\< 12 years the total area will not exceed a maximum of 2% of the body surface area.\n* Total Skin Infection Rating Scale (SIRS) score of at least 8, including pus/exudate score of at least 1\n\nExclusion Criteria:\n\n* Has a bacterial infection, which in the opinion of the investigator, could not be appropriately treated by a topical antibiotic.\n* Has systemic signs and symptoms of infection (e.g. a fever; defined as an axillary temperature over 37.2 °C (99.0 °F)'}, 'identificationModule': {'nctId': 'NCT01397461', 'briefTitle': 'Efficacy and Safety of Ozenoxacin 1% Cream Versus Placebo in the Treatment of Patients With Impetigo', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ferrer Internacional S.A.'}, 'officialTitle': 'A Phase III 3 Arms, Multicenter, Randomised, Investigator-blind Study to Assess the Efficacy and Safety of Ozenoxacin 1% Cream Applied Twice Daily for 5 Days Versus Placebo in the Treatment of Patients With Impetigo', 'orgStudyIdInfo': {'id': 'P-110880-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ozenoxacin 1% cream', 'description': '1% cream', 'interventionNames': ['Drug: ozenoxacin 1% cream']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'ozenoxacin placebo', 'description': 'cream', 'interventionNames': ['Drug: ozenoxacin placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'retapamulin 1% ointment', 'description': '1% ointment', 'interventionNames': ['Drug: retapamulin 1% ointment']}], 'interventions': [{'name': 'ozenoxacin placebo', 'type': 'DRUG', 'description': 'cream', 'armGroupLabels': ['ozenoxacin placebo']}, {'name': 'retapamulin 1% ointment', 'type': 'DRUG', 'description': 'ointment', 'armGroupLabels': ['retapamulin 1% ointment']}, {'name': 'ozenoxacin 1% cream', 'type': 'DRUG', 'description': '1% cream', 'armGroupLabels': ['ozenoxacin 1% cream']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Augsburg', 'country': 'Germany', 'facility': 'Georg Popp', 'geoPoint': {'lat': 48.37154, 'lon': 10.89851}}, {'city': 'Cologne', 'country': 'Germany', 'facility': 'Klaus Chelius', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}, {'city': 'Dresden', 'country': 'Germany', 'facility': 'Roland Aschoff', 'geoPoint': {'lat': 51.05089, 'lon': 13.73832}}, {'city': 'Frankfurt am Main', 'country': 'Germany', 'facility': 'Diamant Thaci', 'geoPoint': {'lat': 50.11552, 'lon': 8.68417}}, {'city': 'Mahlow', 'country': 'Germany', 'facility': 'Stephan Schilling', 'geoPoint': {'lat': 52.36017, 'lon': 13.40954}}, {'city': 'Benoni', 'country': 'South Africa', 'facility': 'Ismail Mitha', 'geoPoint': {'lat': -26.18848, 'lon': 28.32078}}, {'city': 'Bloemfontein', 'country': 'South Africa', 'facility': 'Johan Lombaard', 'geoPoint': {'lat': -29.12107, 'lon': 26.214}}, {'city': 'Dundee', 'country': 'South Africa', 'facility': 'Jan Fourie', 'geoPoint': {'lat': -28.16678, 'lon': 30.23371}}, {'city': 'George', 'country': 'South Africa', 'facility': 'Dawie Kruger', 'geoPoint': {'lat': -33.963, 'lon': 22.46173}}, {'city': 'Hatfield', 'country': 'South Africa', 'facility': 'Philip Nel', 'geoPoint': {'lat': -25.74973, 'lon': 28.24314}}, {'city': 'Johannesburg', 'country': 'South Africa', 'facility': 'Essack Mitha', 'geoPoint': {'lat': -26.20227, 'lon': 28.04363}}, {'city': 'Kraaifontein', 'country': 'South Africa', 'facility': 'J Trokis', 'geoPoint': {'lat': -33.84808, 'lon': 18.71723}}, {'city': 'Middelburg', 'country': 'South Africa', 'facility': 'Mohammed Tayob', 'geoPoint': {'lat': -25.77507, 'lon': 29.46482}}, {'city': 'Port Elizabeth', 'country': 'South Africa', 'facility': 'Mashra Gani', 'geoPoint': {'lat': -33.96109, 'lon': 25.61494}}, {'city': 'Port Elizabeth', 'country': 'South Africa', 'facility': 'Zelda Punt', 'geoPoint': {'lat': -33.96109, 'lon': 25.61494}}, {'city': 'Pretoria', 'country': 'South Africa', 'facility': 'Molefe Phayane', 'geoPoint': {'lat': -25.74486, 'lon': 28.18783}}, {'city': 'Rondebosch', 'country': 'South Africa', 'facility': 'Gail Todd', 'geoPoint': {'lat': -33.96333, 'lon': 18.47639}}, {'city': 'Welkom', 'country': 'South Africa', 'facility': 'Yacoob Vahed', 'geoPoint': {'lat': -27.97742, 'lon': 26.73506}}, {'city': 'Worcester', 'country': 'South Africa', 'facility': 'Christo van Dyk', 'geoPoint': {'lat': -33.64651, 'lon': 19.44852}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ferrer Internacional S.A.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}