Ignite Creation Date:
2025-12-24 @ 7:15 PM
Ignite Modification Date:
2025-12-30 @ 2:43 PM
Study NCT ID:
NCT00777803
Status:
COMPLETED
Last Update Posted:
2012-03-08
First Post:
2008-10-21
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
NT 201 (Xeomin®/Bocouture®) in Comparison With Clostridium Botulinum Toxin Type A in the Treatment of Glabellar Frown Lines
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C545476', 'term': 'incobotulinumtoxinA'}, {'id': 'D019274', 'term': 'Botulinum Toxins, Type A'}], 'ancestors': [{'id': 'D001905', 'term': 'Botulinum Toxins'}, {'id': 'D008666', 'term': 'Metalloendopeptidases'}, {'id': 'D010450', 'term': 'Endopeptidases'}, {'id': 'D010447', 'term': 'Peptide Hydrolases'}, {'id': 'D006867', 'term': 'Hydrolases'}, {'id': 'D004798', 'term': 'Enzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D045726', 'term': 'Metalloproteases'}, {'id': 'D001426', 'term': 'Bacterial Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D001427', 'term': 'Bacterial Toxins'}, {'id': 'D014118', 'term': 'Toxins, Biological'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'matthias.zerm@merz.de', 'phone': '+49 69 1503', 'title': 'Matthias Zerm', 'phoneExt': '865', 'organization': 'Merz Pharmaceuticals GmbH'}, 'certainAgreement': {'otherDetails': 'No results to be published without written agreement by sponsor; manuscripts to be sent to sponsor at least 6 wks before submission. Sponsor to give written opinion within 30 d. Sponsor is entitled to exert influence on the contents of publications, to postpone publications up to 36 months after end of the study, and to name co-authors. In case of justified doubts of sponsor, the INVESTIGATOR will consider these doubts in the publication as long as the scientific neutrality is not affected.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'All SAEs/AEs up to 12 weeks after injection.', 'description': 'The table of "Other Adverse Events" includes all non-serious AEs. The investigator asked the patient for AEs systematically at each visit.', 'eventGroups': [{'id': 'EG000', 'title': 'IncobotulinumtoxinA (Xeomin®/Bocouture®)', 'otherNumAtRisk': 284, 'otherNumAffected': 22, 'seriousNumAtRisk': 284, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'OnabotulinumtoxinA (Vistabel®)', 'otherNumAtRisk': 97, 'otherNumAffected': 12, 'seriousNumAtRisk': 97, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 97, 'numAffected': 7}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 97, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Gastrointestinal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 97, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}], 'seriousEvents': [{'term': 'Joint injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 97, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Encephalitis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 97, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Tibia fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 97, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': "Responder by Independent Rater's Assessment at Maximum Frown at Week 4", 'denoms': [{'units': 'Participants', 'counts': [{'value': '277', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IncobotulinumtoxinA (Xeomin®/Bocouture®)'}, {'id': 'OG001', 'title': 'OnabotulinumtoxinA (Vistabel®)'}], 'classes': [{'categories': [{'measurements': [{'value': '267', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'difference of response rates', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.7', 'ciLowerLimit': '-3.2', 'ciUpperLimit': '7.1', 'estimateComment': 'Difference of response rates = response rate in IncobotulinumtoxinA (Xeomin®/Bocouture®) - response rate in OnabotulinumtoxinA (Vistabel®)', 'groupDescription': 'Null Hypothesis: Response rate of IncobotulinumtoxinA (Xeomin®/Bocouture®) minus the response rate of OnabotulinumtoxinA (Vistabel®) is lower or equal -15% (non-inferiority margin).', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'A two-sided 95% Newcombe confidence interval for proportions (paired data) was applied. The lower bound of the Newcombe-Wilson confidence interval of the difference in response rates between groups was compared to the non-inferiority margin of -15%.'}], 'paramType': 'NUMBER', 'timeFrame': '4 weeks after injection', 'description': "The Outcome Measure Data Table describes the number of responders. A subject is a responder if at least 2 out of 3 independent rater identified a response. A response is defined as an improvement of at least one point on a 4-point facial wrinkle scale from baseline to 4 weeks thereafter at maximum frown. The scale comprises the items 0 = 'none', 1 = 'mild', 2 = 'moderate', 3 = 'severe' wrinkles.", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis per protocol: All subjects who received study medication, for whom a facial wrinkle score at maximum frown was observed at baseline and who had no major protocol deviations. Missing facial wrinkle scores were not imputed.'}, {'type': 'SECONDARY', 'title': "Responder by Independent Rater's Assessment at Maximum Frown at Week 12", 'denoms': [{'units': 'Participants', 'counts': [{'value': '268', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IncobotulinumtoxinA (Xeomin®/Bocouture®)'}, {'id': 'OG001', 'title': 'OnabotulinumtoxinA (Vistabel®)'}], 'classes': [{'categories': [{'measurements': [{'value': '222', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 weeks after injection', 'description': "The Outcome Measure Data Table describes the number of responders. A subject is a responder if at least 2 out of 3 independent rater identified a response. A response is defined as an improvement of at least one point on a 4-point facial wrinkle scale from baseline to 12 weeks thereafter at maximum frown. The scale comprises the items 0 = 'none', 1 = 'mild', 2 = 'moderate', 3 = 'severe' wrinkles.", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis per protocol: All subjects who received study medication, for whom a facial wrinkle score at maximum frown was observed at baseline and who had no major protocol deviations. Missing facial wrinkle scores were not imputed.'}, {'type': 'SECONDARY', 'title': "Responder by Independent Rater's Assessment at Rest at Week 4", 'denoms': [{'units': 'Participants', 'counts': [{'value': '277', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IncobotulinumtoxinA (Xeomin®/Bocouture®)'}, {'id': 'OG001', 'title': 'OnabotulinumtoxinA (Vistabel®)'}], 'classes': [{'categories': [{'measurements': [{'value': '115', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '4 weeks after injection', 'description': "The Outcome Measure Data Table describes the number of responders. A subject is a responder if at least 2 out of 3 independent rater identified a response. A response is defined as an improvement of at least one point on a 4-point facial wrinkle scale from baseline to 4 weeks thereafter at rest. The scale comprises the items 0 = 'none', 1 = 'mild', 2 = 'moderate', 3 = 'severe' wrinkles.", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis per protocol: All subjects who received study medication, for whom a facial wrinkle score at maximum frown was observed at baseline and who had no major protocol deviations. Missing facial wrinkle scores were not imputed.'}, {'type': 'SECONDARY', 'title': "Responder by Independent Rater's Assessment at Rest at Week 12", 'denoms': [{'units': 'Participants', 'counts': [{'value': '268', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IncobotulinumtoxinA (Xeomin®/Bocouture®)'}, {'id': 'OG001', 'title': 'OnabotulinumtoxinA (Vistabel®)'}], 'classes': [{'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 weeks after injection', 'description': "The Outcome Measure Data Table describes the number of responders. A subject is a responder if at least 2 out of 3 independent rater identified a response. A response is defined as an improvement of at least one point on a 4-point facial wrinkle scale from baseline to 12 weeks thereafter at rest. The scale comprises the items 0 = 'none', 1 = 'mild', 2 = 'moderate', 3 = 'severe' wrinkles.", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis per protocol: All subjects who received study medication, for whom a facial wrinkle score at maximum frown was observed at baseline and who had no major protocol deviations. Missing facial wrinkle scores were not imputed.'}, {'type': 'SECONDARY', 'title': "Responder by Investigator's Assessment at Maximum Frown at Week 4", 'denoms': [{'units': 'Participants', 'counts': [{'value': '277', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IncobotulinumtoxinA (Xeomin®/Bocouture®)'}, {'id': 'OG001', 'title': 'OnabotulinumtoxinA (Vistabel®)'}], 'classes': [{'categories': [{'measurements': [{'value': '274', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '4 weeks after injection', 'description': "The Outcome Measure Data Table describes the number of responders. A response is defined as an improvement of at least one point on a 4-point facial wrinkle scale from baseline to 4 weeks thereafter at maximum frown rated by the investigator. The scale comprises the items 0 = 'none', 1 = 'mild', 2 = 'moderate', 3 = 'severe' wrinkles.", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis per protocol: All subjects who received study medication, for whom a facial wrinkle score at maximum frown was observed at baseline and who had no major protocol deviations. Missing facial wrinkle scores were not imputed.'}, {'type': 'SECONDARY', 'title': "Responder by Investigator's Assessment at Maximum Frown at Week 12", 'denoms': [{'units': 'Participants', 'counts': [{'value': '268', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IncobotulinumtoxinA (Xeomin®/Bocouture®)'}, {'id': 'OG001', 'title': 'OnabotulinumtoxinA (Vistabel®)'}], 'classes': [{'categories': [{'measurements': [{'value': '220', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 weeks after injection', 'description': "The Outcome Measure Data Table describes the number of responders. A response is defined as an improvement of at least one point on a 4-point facial wrinkle scale from baseline to 12 weeks thereafter at maximum frown rated by the investigator. The scale comprises the items 0 = 'none', 1 = 'mild', 2 = 'moderate', 3 = 'severe' wrinkles.", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis per protocol: All subjects who received study medication, for whom a facial wrinkle score at maximum frown was observed at baseline and who had no major protocol deviations. Missing facial wrinkle scores were not imputed.'}, {'type': 'SECONDARY', 'title': "Responder by Investigator's Assessment at Rest at Week 4", 'denoms': [{'units': 'Participants', 'counts': [{'value': '277', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IncobotulinumtoxinA (Xeomin®/Bocouture®)'}, {'id': 'OG001', 'title': 'OnabotulinumtoxinA (Vistabel®)'}], 'classes': [{'categories': [{'measurements': [{'value': '210', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '4 weeks after injection', 'description': "The Outcome Measure Data Table describes the number of responders. A response is defined as an improvement of at least one point on a 4-point facial wrinkle scale from baseline to 4 weeks thereafter at rest rated by the investigator. The scale comprises the items 0 = 'none', 1 = 'mild', 2 = 'moderate', 3 = 'severe' wrinkles.", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis per protocol: All subjects who received study medication, for whom a facial wrinkle score at maximum frown was observed at baseline and who had no major protocol deviations. Missing facial wrinkle scores were not imputed.'}, {'type': 'SECONDARY', 'title': "Responder by Investigator's Assessment at Rest at Week 12", 'denoms': [{'units': 'Participants', 'counts': [{'value': '268', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IncobotulinumtoxinA (Xeomin®/Bocouture®)'}, {'id': 'OG001', 'title': 'OnabotulinumtoxinA (Vistabel®)'}], 'classes': [{'categories': [{'measurements': [{'value': '166', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 weeks after injection', 'description': "The Outcome Measure Data Table describes the number of responders. A response is defined as an improvement of at least one point on a 4-point facial wrinkle scale from baseline to 12 weeks thereafter at rest rated by the investigator. The scale comprises the items 0 = 'none', 1 = 'mild', 2 = 'moderate', 3 = 'severe' wrinkles.", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis per protocol: All subjects who received study medication, for whom a facial wrinkle score at maximum frown was observed at baseline and who had no major protocol deviations. Missing facial wrinkle scores were not imputed.'}, {'type': 'SECONDARY', 'title': "Responder by Patient's Assessment at Maximum Frown at Week 4", 'denoms': [{'units': 'Participants', 'counts': [{'value': '277', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IncobotulinumtoxinA (Xeomin®/Bocouture®)'}, {'id': 'OG001', 'title': 'OnabotulinumtoxinA (Vistabel®)'}], 'classes': [{'categories': [{'measurements': [{'value': '260', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '4 weeks after injection', 'description': "The Outcome Measure Data Table describes the number of responders. A response is defined as an improvement of at least one point on a 4-point facial wrinkle scale from baseline to 4 weeks thereafter at maximum frown rated by the patient. The scale comprises the items 0 = 'none', 1 = 'mild', 2 = 'moderate', 3 = 'severe' wrinkles.", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis per protocol: All subjects who received study medication, for whom a facial wrinkle score at maximum frown was observed at baseline and who had no major protocol deviations. Missing facial wrinkle scores were not imputed.'}, {'type': 'SECONDARY', 'title': "Responder by Patient's Assessment at Maximum Frown at Week 12", 'denoms': [{'units': 'Participants', 'counts': [{'value': '268', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IncobotulinumtoxinA (Xeomin®/Bocouture®)'}, {'id': 'OG001', 'title': 'OnabotulinumtoxinA (Vistabel®)'}], 'classes': [{'categories': [{'measurements': [{'value': '202', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 weeks after injection', 'description': "The Outcome Measure Data Table describes the number of responders. A response is defined as an improvement of at least one point on a 4-point facial wrinkle scale from baseline to 12 weeks thereafter at maximum frown rated by the patient. The scale comprises the items 0 = 'none', 1 = 'mild', 2 = 'moderate', 3 = 'severe' wrinkles.", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis per protocol: All subjects who received study medication, for whom a facial wrinkle score at maximum frown was observed at baseline and who had no major protocol deviations. Missing facial wrinkle scores were not imputed.'}, {'type': 'SECONDARY', 'title': "Responder by Patient's Assessment at Rest at Week 4", 'denoms': [{'units': 'Participants', 'counts': [{'value': '277', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IncobotulinumtoxinA (Xeomin®/Bocouture®)'}, {'id': 'OG001', 'title': 'OnabotulinumtoxinA (Vistabel®)'}], 'classes': [{'categories': [{'measurements': [{'value': '193', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '4 weeks after injection', 'description': "The Outcome Measure Data Table describes the number of responders. A response is defined as an improvement of at least one point on a 4-point facial wrinkle scale from baseline to 4 weeks thereafter at rest rated by the patient. The scale comprises the items 0 = 'none', 1 = 'mild', 2 = 'moderate', 3 = 'severe' wrinkles.", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis per protocol: All subjects who received study medication, for whom a facial wrinkle score at maximum frown was observed at baseline and who had no major protocol deviations. Missing facial wrinkle scores were not imputed.'}, {'type': 'SECONDARY', 'title': "Response by Patient's Assessment at Rest at Week 12", 'denoms': [{'units': 'Participants', 'counts': [{'value': '268', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IncobotulinumtoxinA (Xeomin®/Bocouture®)'}, {'id': 'OG001', 'title': 'OnabotulinumtoxinA (Vistabel®)'}], 'classes': [{'categories': [{'measurements': [{'value': '152', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 weeks after injection', 'description': "The Outcome Measure Data Table describes the number of responders. A response is defined as an improvement of at least one point on a 4-point facial wrinkle scale from baseline to 12 weeks thereafter rated by the patient. The scale comprises the items 0 = 'none', 1 = 'mild', 2 = 'moderate', 3 = 'severe' wrinkles.", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis per protocol: All subjects who received study medication, for whom a facial wrinkle score at maximum frown was observed at baseline and who had no major protocol deviations. Missing facial wrinkle scores were not imputed.'}, {'type': 'SECONDARY', 'title': "Responder by Patient's Global Assessment at Week 4", 'denoms': [{'units': 'Participants', 'counts': [{'value': '277', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IncobotulinumtoxinA (Xeomin®/Bocouture®)'}, {'id': 'OG001', 'title': 'OnabotulinumtoxinA (Vistabel®)'}], 'classes': [{'categories': [{'measurements': [{'value': '259', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '4 weeks after injection', 'description': 'The Outcome Measure Data Table describes the number of responders. A response is defined as a score of at least +2 (moderate improvement) on a 9-point scale (range from +4 complete improvement to -4 very marked worsening) 4 weeks after treatment rated by the patient.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis per protocol: All subjects who received study medication, for whom a facial wrinkle score at maximum frown was observed at baseline and who had no major protocol deviations. Missing scores were not imputed.'}, {'type': 'SECONDARY', 'title': "Responder by Patient's Global Assessment at Week 12", 'denoms': [{'units': 'Participants', 'counts': [{'value': '268', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IncobotulinumtoxinA (Xeomin®/Bocouture®)'}, {'id': 'OG001', 'title': 'OnabotulinumtoxinA (Vistabel®)'}], 'classes': [{'categories': [{'measurements': [{'value': '229', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 weeks after injection', 'description': 'The Outcome Measure Data Table describes the number of responders. A response is defined as a score of at least +2 (moderate improvement) on a 9-point scale (range from +4 complete improvement to -4 very marked worsening) 12 weeks after treatment rated by the patient.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis per protocol: All subjects who received study medication, for whom a facial wrinkle score at maximum frown was observed at baseline and who had no major protocol deviations. Missing scores were not imputed.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'IncobotulinumtoxinA (Xeomin®/Bocouture®)'}, {'id': 'FG001', 'title': 'OnabotulinumtoxinA (Vistabel®)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '284'}, {'groupId': 'FG001', 'numSubjects': '97'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '269'}, {'groupId': 'FG001', 'numSubjects': '90'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '7'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Non-compliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}], 'preAssignmentDetails': 'Subjects were randomized according to a ratio of 3:1 to be either treated with IncobotulinumtoxinA (Bocouture®) or with OnabotulinumtoxinA (Vistabel®).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '284', 'groupId': 'BG000'}, {'value': '97', 'groupId': 'BG001'}, {'value': '381', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'IncobotulinumtoxinA (Xeomin®/Bocouture®)'}, {'id': 'BG001', 'title': 'OnabotulinumtoxinA (Vistabel®)'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '41.6', 'spread': '5.7', 'groupId': 'BG000'}, {'value': '42.0', 'spread': '6.0', 'groupId': 'BG001'}, {'value': '41.7', 'spread': '5.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '284', 'groupId': 'BG000'}, {'value': '97', 'groupId': 'BG001'}, {'value': '381', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 381}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-03', 'completionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-03-07', 'studyFirstSubmitDate': '2008-10-21', 'resultsFirstSubmitDate': '2012-01-23', 'studyFirstSubmitQcDate': '2008-10-21', 'lastUpdatePostDateStruct': {'date': '2012-03-08', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-01-23', 'studyFirstPostDateStruct': {'date': '2008-10-22', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-02-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Responder by Independent Rater's Assessment at Maximum Frown at Week 4", 'timeFrame': '4 weeks after injection', 'description': "The Outcome Measure Data Table describes the number of responders. A subject is a responder if at least 2 out of 3 independent rater identified a response. A response is defined as an improvement of at least one point on a 4-point facial wrinkle scale from baseline to 4 weeks thereafter at maximum frown. The scale comprises the items 0 = 'none', 1 = 'mild', 2 = 'moderate', 3 = 'severe' wrinkles."}], 'secondaryOutcomes': [{'measure': "Responder by Independent Rater's Assessment at Maximum Frown at Week 12", 'timeFrame': '12 weeks after injection', 'description': "The Outcome Measure Data Table describes the number of responders. A subject is a responder if at least 2 out of 3 independent rater identified a response. A response is defined as an improvement of at least one point on a 4-point facial wrinkle scale from baseline to 12 weeks thereafter at maximum frown. The scale comprises the items 0 = 'none', 1 = 'mild', 2 = 'moderate', 3 = 'severe' wrinkles."}, {'measure': "Responder by Independent Rater's Assessment at Rest at Week 4", 'timeFrame': '4 weeks after injection', 'description': "The Outcome Measure Data Table describes the number of responders. A subject is a responder if at least 2 out of 3 independent rater identified a response. A response is defined as an improvement of at least one point on a 4-point facial wrinkle scale from baseline to 4 weeks thereafter at rest. The scale comprises the items 0 = 'none', 1 = 'mild', 2 = 'moderate', 3 = 'severe' wrinkles."}, {'measure': "Responder by Independent Rater's Assessment at Rest at Week 12", 'timeFrame': '12 weeks after injection', 'description': "The Outcome Measure Data Table describes the number of responders. A subject is a responder if at least 2 out of 3 independent rater identified a response. A response is defined as an improvement of at least one point on a 4-point facial wrinkle scale from baseline to 12 weeks thereafter at rest. The scale comprises the items 0 = 'none', 1 = 'mild', 2 = 'moderate', 3 = 'severe' wrinkles."}, {'measure': "Responder by Investigator's Assessment at Maximum Frown at Week 4", 'timeFrame': '4 weeks after injection', 'description': "The Outcome Measure Data Table describes the number of responders. A response is defined as an improvement of at least one point on a 4-point facial wrinkle scale from baseline to 4 weeks thereafter at maximum frown rated by the investigator. The scale comprises the items 0 = 'none', 1 = 'mild', 2 = 'moderate', 3 = 'severe' wrinkles."}, {'measure': "Responder by Investigator's Assessment at Maximum Frown at Week 12", 'timeFrame': '12 weeks after injection', 'description': "The Outcome Measure Data Table describes the number of responders. A response is defined as an improvement of at least one point on a 4-point facial wrinkle scale from baseline to 12 weeks thereafter at maximum frown rated by the investigator. The scale comprises the items 0 = 'none', 1 = 'mild', 2 = 'moderate', 3 = 'severe' wrinkles."}, {'measure': "Responder by Investigator's Assessment at Rest at Week 4", 'timeFrame': '4 weeks after injection', 'description': "The Outcome Measure Data Table describes the number of responders. A response is defined as an improvement of at least one point on a 4-point facial wrinkle scale from baseline to 4 weeks thereafter at rest rated by the investigator. The scale comprises the items 0 = 'none', 1 = 'mild', 2 = 'moderate', 3 = 'severe' wrinkles."}, {'measure': "Responder by Investigator's Assessment at Rest at Week 12", 'timeFrame': '12 weeks after injection', 'description': "The Outcome Measure Data Table describes the number of responders. A response is defined as an improvement of at least one point on a 4-point facial wrinkle scale from baseline to 12 weeks thereafter at rest rated by the investigator. The scale comprises the items 0 = 'none', 1 = 'mild', 2 = 'moderate', 3 = 'severe' wrinkles."}, {'measure': "Responder by Patient's Assessment at Maximum Frown at Week 4", 'timeFrame': '4 weeks after injection', 'description': "The Outcome Measure Data Table describes the number of responders. A response is defined as an improvement of at least one point on a 4-point facial wrinkle scale from baseline to 4 weeks thereafter at maximum frown rated by the patient. The scale comprises the items 0 = 'none', 1 = 'mild', 2 = 'moderate', 3 = 'severe' wrinkles."}, {'measure': "Responder by Patient's Assessment at Maximum Frown at Week 12", 'timeFrame': '12 weeks after injection', 'description': "The Outcome Measure Data Table describes the number of responders. A response is defined as an improvement of at least one point on a 4-point facial wrinkle scale from baseline to 12 weeks thereafter at maximum frown rated by the patient. The scale comprises the items 0 = 'none', 1 = 'mild', 2 = 'moderate', 3 = 'severe' wrinkles."}, {'measure': "Responder by Patient's Assessment at Rest at Week 4", 'timeFrame': '4 weeks after injection', 'description': "The Outcome Measure Data Table describes the number of responders. A response is defined as an improvement of at least one point on a 4-point facial wrinkle scale from baseline to 4 weeks thereafter at rest rated by the patient. The scale comprises the items 0 = 'none', 1 = 'mild', 2 = 'moderate', 3 = 'severe' wrinkles."}, {'measure': "Response by Patient's Assessment at Rest at Week 12", 'timeFrame': '12 weeks after injection', 'description': "The Outcome Measure Data Table describes the number of responders. A response is defined as an improvement of at least one point on a 4-point facial wrinkle scale from baseline to 12 weeks thereafter rated by the patient. The scale comprises the items 0 = 'none', 1 = 'mild', 2 = 'moderate', 3 = 'severe' wrinkles."}, {'measure': "Responder by Patient's Global Assessment at Week 4", 'timeFrame': '4 weeks after injection', 'description': 'The Outcome Measure Data Table describes the number of responders. A response is defined as a score of at least +2 (moderate improvement) on a 9-point scale (range from +4 complete improvement to -4 very marked worsening) 4 weeks after treatment rated by the patient.'}, {'measure': "Responder by Patient's Global Assessment at Week 12", 'timeFrame': '12 weeks after injection', 'description': 'The Outcome Measure Data Table describes the number of responders. A response is defined as a score of at least +2 (moderate improvement) on a 9-point scale (range from +4 complete improvement to -4 very marked worsening) 12 weeks after treatment rated by the patient.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Glabellar Frown Lines']}, 'referencesModule': {'references': [{'pmid': '21134045', 'type': 'RESULT', 'citation': 'Sattler G, Callander MJ, Grablowitz D, Walker T, Bee EK, Rzany B, Flynn TC, Carruthers A. Noninferiority of incobotulinumtoxinA, free from complexing proteins, compared with another botulinum toxin type A in the treatment of glabellar frown lines. Dermatol Surg. 2010 Dec;36 Suppl 4:2146-54. doi: 10.1111/j.1524-4725.2010.01706.x.'}]}, 'descriptionModule': {'briefSummary': 'NT 201, also known as IncobotulinumtoxinA (Xeomin®/Bocouture®), is a Botulinum toxin type A preparation free of complexing proteins (150 kiloDalton). Injected into the muscle, NT201 causes a reversible local relaxation of the injected muscle. Botulinum toxin type A is used for aesthetic treatment of mimic wrinkles and in the therapy of neurologic diseases. This study will investigate the safety and efficacy (non-inferiority) of NT 201 in comparison with OnabotulinumtoxinA (Vistabel®) in the treatment of glabellar frown lines.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Main Inclusion Criteria:\n\n• Moderate to severe glabellar frown lines at maximum frown (severity score of 2 or 3 on a 4-point facial wrinkle scale) as assessed by the investigator's rating: 0 = 'none', 1 = 'mild', 2 = 'moderate', 3 = 'severe'.\n\nMain Exclusion Criteria:\n\n* Marked facial asymmetry.\n* Ptosis of eyelid and/or eyebrow."}, 'identificationModule': {'nctId': 'NCT00777803', 'acronym': 'Head2Head', 'briefTitle': 'NT 201 (Xeomin®/Bocouture®) in Comparison With Clostridium Botulinum Toxin Type A in the Treatment of Glabellar Frown Lines', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merz Pharmaceuticals GmbH'}, 'officialTitle': 'A Prospective, Multicenter, Randomized, Rater- and Subject-Blind, Parallel Group Trial to Investigate the Non-Inferiority of NT 201, Free of Complexing Proteins, in Comparison With Clostridium Botulinum Toxin Type A in the Treatment of Glabellar Frown Lines', 'orgStudyIdInfo': {'id': 'MRZ 60201 GL_3002'}, 'secondaryIdInfos': [{'id': '2008-002713-40', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'IncobotulinumtoxinA (Xeomin®/Bocouture®)', 'description': 'IncobotulinumtoxinA (Xeomin®/Bocouture®), 24 units; mode of administration: intramuscular injection.', 'interventionNames': ['Drug: NT 201 (IncobotulinumtoxinA (Xeomin®/Bocouture®))']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'OnabotulinumtoxinA (Vistabel®)', 'description': 'OnabotulinumtoxinA (Vistabel®), 24 units; mode of administration: intramuscular injection.', 'interventionNames': ['Drug: OnabotulinumtoxinA (Vistabel®)']}], 'interventions': [{'name': 'NT 201 (IncobotulinumtoxinA (Xeomin®/Bocouture®))', 'type': 'DRUG', 'otherNames': ['"Botulinum toxin type A (150 kiloDalton), free from complexing proteins"'], 'description': 'NT201, also known as IncobotulinumtoxinA (Xeomin®/Bocouture®), active ingredient: Clostridium botulinum neurotoxin type A free from complexing proteins, powder for solution for injection dose, 24 units; one injection session of solution, prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl). Of the 0.6 mL total injection volume, an aliquot of 0.15 mL was administered in the procerus muscle, aliquots of 0.125 mL were administered in the medial part of the both corrugator muscles and aliquots of 0.1 mL were administered in the middle part of both corrugator muscles.', 'armGroupLabels': ['IncobotulinumtoxinA (Xeomin®/Bocouture®)']}, {'name': 'OnabotulinumtoxinA (Vistabel®)', 'type': 'DRUG', 'otherNames': ['"BOTOX® Cosmetic"', '"Botulinum toxin type A (900 kiloDalton)"'], 'description': 'OnabotulinumtoxinA (Vistabel®), active ingredient: Clostridium botulinum neurotoxin type A, powder for solution for injection dose, 24 units; one injection session of solution, prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl). Of the 0.6 mL total injection volume, an aliquot of 0.15 mL was administered in the procerus muscle, aliquots of 0.125 mL were administered in the medial part of the both corrugator muscles and aliquots of 0.1 mL were administered in the middle part of both corrugator muscles.', 'armGroupLabels': ['OnabotulinumtoxinA (Vistabel®)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Baden', 'country': 'Austria', 'geoPoint': {'lat': 48.00543, 'lon': 16.23264}}, {'city': 'Krems', 'country': 'Austria', 'geoPoint': {'lat': 48.40921, 'lon': 15.61415}}, {'city': 'Salzburg', 'country': 'Austria', 'geoPoint': {'lat': 47.79941, 'lon': 13.04399}}, {'city': 'Vienna', 'country': 'Austria', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'city': 'Bad Soden', 'country': 'Germany', 'geoPoint': {'lat': 50.28857, 'lon': 9.36404}}, {'city': 'Böblingen', 'country': 'Germany', 'geoPoint': {'lat': 48.68212, 'lon': 9.01171}}, {'city': 'Cologne', 'country': 'Germany', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}, {'city': 'Darmstadt', 'country': 'Germany', 'geoPoint': {'lat': 49.87167, 'lon': 8.65027}}, {'city': 'Frankfurt', 'country': 'Germany', 'geoPoint': {'lat': 49.68333, 'lon': 10.53333}}, {'city': 'Korschenbroich', 'country': 'Germany', 'geoPoint': {'lat': 51.19139, 'lon': 6.51352}}, {'city': 'Ludwigshafen', 'country': 'Germany', 'geoPoint': {'lat': 47.81663, 'lon': 9.06138}}, {'city': 'Munich', 'country': 'Germany', 'geoPoint': {'lat': 48.13743, 'lon': 11.57549}}, {'city': 'Wuppertal', 'country': 'Germany', 'geoPoint': {'lat': 51.25627, 'lon': 7.14816}}, {'city': 'Glasgow', 'country': 'United Kingdom', 'geoPoint': {'lat': 55.86515, 'lon': -4.25763}}, {'city': 'Manchester', 'country': 'United Kingdom', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}, {'city': 'Suttion Coldfield', 'country': 'United Kingdom'}, {'city': 'Winchester', 'country': 'United Kingdom', 'geoPoint': {'lat': 51.06513, 'lon': -1.3187}}], 'overallOfficials': [{'name': 'Medical Expert', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merz Pharmaceuticals GmbH'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merz Pharmaceuticals GmbH', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}