Ignite Creation Date:
2025-12-24 @ 2:56 PM
Ignite Modification Date:
2026-02-04 @ 7:10 PM
Study NCT ID:
NCT03583359
Status:
COMPLETED
Last Update Posted:
2023-11-14
First Post:
2018-06-28
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluation of Effectiveness and Safety of Radiesse (+) to Improve the Contour of Jawline by Adding Volume to the Jawline
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2022-06-06', 'type': 'ACTUAL'}}}}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Aesthetic.Trials@merz.com', 'phone': '+49 69 1503 1', 'title': 'Public Disclosure Manager', 'organization': 'Merz Pharmaceuticals GmbH'}, 'certainAgreement': {'otherDetails': 'Publication of study information usually requires agreement with the sponsor. In case of justified doubts by the 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': 'From first treatment up to the end of study (Week 60)', 'description': 'The investigator reported AEs systematically at each visit.', 'eventGroups': [{'id': 'EG000', 'title': 'Treatment With Radiesse (+)', 'description': 'Right and left jawline injected with Radiesse (+).', 'otherNumAtRisk': 122, 'deathsNumAtRisk': 122, 'otherNumAffected': 25, 'seriousNumAtRisk': 122, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Control/Delayed Treatment With Radiesse (+)', 'description': 'Participants did not receive treatment for the first 12 weeks.', 'otherNumAtRisk': 53, 'deathsNumAtRisk': 53, 'otherNumAffected': 7, 'seriousNumAtRisk': 53, 'deathsNumAffected': 0, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Injection site mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Injection site bruising', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}], 'seriousEvents': [{'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Erysipelas', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Responder Rate According to the Merz Jawline Assessment Scale (MJAS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment With Radiesse (+)', 'description': 'Right and left jawline injected with Radiesse (+).'}, {'id': 'OG001', 'title': 'Control/Delayed Treatment With Radiesse (+)', 'description': 'Participants did not receive treatment for the first 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '75.6', 'groupId': 'OG000', 'lowerLimit': '67.3', 'upperLimit': '82.3'}, {'value': '8.8', 'groupId': 'OG001', 'lowerLimit': '3.8', 'upperLimit': '18.9'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Responder Rate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '66.8', 'ciLowerLimit': '53.7', 'ciUpperLimit': '75.2', 'estimateComment': 'Two-sided Newcombe confidence intervals (CIs) were calculated for difference in responder rate.', 'statisticalMethod': "Fisher's exact test", 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': "The Fisher's exact test was utilized to test the superiority of treatment (Radiesse \\[+\\]) over control group."}], 'paramType': 'NUMBER', 'timeFrame': 'At Week 12', 'description': 'MJAS was a 5-point scale (0-4 scores; higher scores mean worse outcome). Responder rate was defined as percentage of participants with a greater than or equal to (\\>=) 1-point improvement.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population consisted of all randomized participants.'}, {'type': 'PRIMARY', 'title': 'Number of Participants Reporting One or More Device and/or Injection Related Treatment-emergent Adverse Events (TEAEs) and Device and/or Injection Related Serious TEAEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment With Radiesse (+)', 'description': 'Right and left jawline injected with Radiesse (+).'}, {'id': 'OG001', 'title': 'Control/Delayed Treatment With Radiesse (+)', 'description': 'Participants did not receive treatment for the first 12 weeks.'}], 'classes': [{'title': 'Participants with Device and/or Injection Related TEAEs', 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'Participants with Device and/or Injection Related Serious TEAEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline up to end of study (Week 60)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety evaluation set (SES) was the subset of all participants who were exposed to study medication at least once.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Face-Q Satisfaction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '115', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment With Radiesse (+)', 'description': 'Right and left jawline injected with Radiesse (+).'}, {'id': 'OG001', 'title': 'Control/Delayed Treatment With Radiesse (+)', 'description': 'Participants did not receive treatment for the first 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '269.8', 'groupId': 'OG000', 'lowerLimit': '215.1', 'upperLimit': '324.6'}, {'value': '-9.4', 'groupId': 'OG001', 'lowerLimit': '-28.2', 'upperLimit': '9.5'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline up to Week 12', 'description': 'The participant assessed satisfaction using the Face-Q Satisfaction with Lower Face and Jawline module (Rasch transformed score 0-100; higher scores mean better outcome).', 'unitOfMeasure': 'percent change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population consisted of all randomized participants. Here "overall number of participants analyzed" were participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Global Aesthetic Improvement Scale (GAIS) Scores as Assessed by the Treating Investigator', 'denoms': [{'units': 'Participants', 'counts': [{'value': '116', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment With Radiesse (+)', 'description': 'Right and left jawline injected with Radiesse (+).'}], 'classes': [{'categories': [{'title': 'Very Much Improved', 'measurements': [{'value': '37', 'groupId': 'OG000'}]}, {'title': 'Much Improved', 'measurements': [{'value': '51', 'groupId': 'OG000'}]}, {'title': 'Improved', 'measurements': [{'value': '27', 'groupId': 'OG000'}]}, {'title': 'No Change', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Worse', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Much Worse', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Very Much Worse', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Week 12', 'description': 'GAIS ratings (-3 to +3 scores; lower scores mean worse outcome).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population consisted of all randomized participants. Here "overall number of participants analyzed" were participants who were evaluable for this outcome measure. As planned, this OM was evaluated only for participants in treatment with Radiesse (+) group.'}, {'type': 'SECONDARY', 'title': 'GAIS Scores as Assessed by Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '116', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment With Radiesse (+)', 'description': 'Right and left jawline injected with Radiesse (+).'}], 'classes': [{'categories': [{'title': 'Very Much Improved', 'measurements': [{'value': '32', 'groupId': 'OG000'}]}, {'title': 'Much Improved', 'measurements': [{'value': '38', 'groupId': 'OG000'}]}, {'title': 'Improved', 'measurements': [{'value': '39', 'groupId': 'OG000'}]}, {'title': 'No Change', 'measurements': [{'value': '6', 'groupId': 'OG000'}]}, {'title': 'Worse', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Much Worse', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Very Much Worse', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Week 12', 'description': 'GAIS ratings (-3 to +3 scores; lower scores mean worse outcome).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population consisted of all randomized participants. Here "overall number of participants analyzed" were participants who were evaluable for this outcome measure. As planned, this OM was evaluated only for participants in treatment with Radiesse (+) group.'}, {'type': 'SECONDARY', 'title': 'Responder Rate According to the MJAS as Assessed by Independent Panel Reviewers (IPRs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment With Radiesse (+)', 'description': 'Right and left jawline injected with Radiesse (+).'}, {'id': 'OG001', 'title': 'Control/Delayed Treatment With Radiesse (+)', 'description': 'Participants did not receive treatment for the first 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '47.7', 'groupId': 'OG000', 'lowerLimit': '38.7', 'upperLimit': '57.0'}, {'value': '8.2', 'groupId': 'OG001', 'lowerLimit': '3.2', 'upperLimit': '19.2'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Week 12', 'description': 'MJAS was a 5-point scale (0-4 scores; higher scores mean worse outcome). Responder rate was defined as percentage of participants with a \\>=1-point improvement.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population consisted of all randomized participants. Here "overall number of participants analyzed" were participants who were evaluable for this outcome measure.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Treatment With Radiesse (+)', 'description': 'Right and left jawline injected with Radiesse (+).'}, {'id': 'FG001', 'title': 'Control/Delayed Treatment With Radiesse (+)', 'description': 'Participants did not receive treatment for the first 12 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '123'}, {'groupId': 'FG001', 'numSubjects': '57'}]}, {'type': 'Treated Participants', 'achievements': [{'groupId': 'FG000', 'numSubjects': '122'}, {'groupId': 'FG001', 'numSubjects': '53'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '94'}, {'groupId': 'FG001', 'numSubjects': '45'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '29'}, {'groupId': 'FG001', 'numSubjects': '12'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': '15 investigational sites in the United States.', 'preAssignmentDetails': 'A total of 180 participants were enrolled and randomized in the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'BG000'}, {'value': '57', 'groupId': 'BG001'}, {'value': '180', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Treatment With Radiesse (+)', 'description': 'Right and left jawline injected with Radiesse (+).'}, {'id': 'BG001', 'title': 'Control/Delayed Treatment With Radiesse (+)', 'description': 'Participants did not receive treatment for the first 12 weeks.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '55.5', 'spread': '7.3', 'groupId': 'BG000'}, {'value': '55.0', 'spread': '6.6', 'groupId': 'BG001'}, {'value': '55.3', 'spread': '7.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '102', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '146', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '101', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '149', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '103', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '145', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The Intent-to-Treat (ITT) population consisted of all randomized participants.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-05-02', 'size': 3599249, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-05-03T05:36', 'hasProtocol': True}, {'date': '2022-05-02', 'size': 420540, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-05-03T05:37', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 180}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-08-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'dispFirstSubmitDate': '2020-05-15', 'completionDateStruct': {'date': '2020-03-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-10', 'studyFirstSubmitDate': '2018-06-28', 'dispFirstSubmitQcDate': '2022-06-20', 'resultsFirstSubmitDate': '2022-05-10', 'studyFirstSubmitQcDate': '2018-06-28', 'dispFirstPostDateStruct': {'date': '2022-06-28', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2023-11-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-06-20', 'studyFirstPostDateStruct': {'date': '2018-07-11', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-06-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Responder Rate According to the Merz Jawline Assessment Scale (MJAS)', 'timeFrame': 'At Week 12', 'description': 'MJAS was a 5-point scale (0-4 scores; higher scores mean worse outcome). Responder rate was defined as percentage of participants with a greater than or equal to (\\>=) 1-point improvement.'}, {'measure': 'Number of Participants Reporting One or More Device and/or Injection Related Treatment-emergent Adverse Events (TEAEs) and Device and/or Injection Related Serious TEAEs', 'timeFrame': 'Baseline up to end of study (Week 60)'}], 'secondaryOutcomes': [{'measure': 'Percent Change From Baseline in Face-Q Satisfaction', 'timeFrame': 'Baseline up to Week 12', 'description': 'The participant assessed satisfaction using the Face-Q Satisfaction with Lower Face and Jawline module (Rasch transformed score 0-100; higher scores mean better outcome).'}, {'measure': 'Global Aesthetic Improvement Scale (GAIS) Scores as Assessed by the Treating Investigator', 'timeFrame': 'At Week 12', 'description': 'GAIS ratings (-3 to +3 scores; lower scores mean worse outcome).'}, {'measure': 'GAIS Scores as Assessed by Participants', 'timeFrame': 'At Week 12', 'description': 'GAIS ratings (-3 to +3 scores; lower scores mean worse outcome).'}, {'measure': 'Responder Rate According to the MJAS as Assessed by Independent Panel Reviewers (IPRs)', 'timeFrame': 'At Week 12', 'description': 'MJAS was a 5-point scale (0-4 scores; higher scores mean worse outcome). Responder rate was defined as percentage of participants with a \\>=1-point improvement.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Improvement of Jawline Contour']}, 'referencesModule': {'references': [{'pmid': '34784131', 'type': 'BACKGROUND', 'citation': 'Moradi A, Green J, Cohen J, Joseph J, Dakovic R, Odena G, Verma A, Scher R. Effectiveness and Safety of Calcium Hydroxylapatite With Lidocaine for Improving Jawline Contour. J Drugs Dermatol. 2021 Nov 1;20(11):1231-1238. doi: 10.36849/jdd.6442.'}, {'pmid': '39505354', 'type': 'DERIVED', 'citation': 'Moradi A, Dakovic R. Plain language summary of the pivotal study of calcium hydroxylapatite with lidocaine for improvement of jawline contour. J Dermatolog Treat. 2024 Dec;35(1):2421435. doi: 10.1080/09546634.2024.2421435. Epub 2024 Nov 6.'}, {'pmid': '38934231', 'type': 'DERIVED', 'citation': 'Green JB, Del Campo R, Durkin AJ, Funt DK, Nasrallah N, Martinez K, Moradi A. Long-term duration and safety of Radiesse (+) for the treatment of jawline. J Cosmet Dermatol. 2024 Oct;23(10):3202-3209. doi: 10.1111/jocd.16436. Epub 2024 Jun 27.'}]}, 'descriptionModule': {'briefSummary': 'To demonstrate the effectiveness and safety of Radiesse (+) following deep (subdermal and/or supraperiosteal) injection to improve the contour of jawline by adding volume to the jawline.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '22 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Has right and left jawline ratings of 2 or 3 (moderate or severe) on the Merz Jawline Assessment Scale (MJAS).\n2. Has the same MJAS score on both jawlines (that is, jawlines are symmetrical).\n3. Is greater than or equal to (\\>=) 22 and less than or equal to (\\<=) 65 years of age.\n\nExclusion Criteria:\n\n1. Ever been treated with fat injections or permanent fillers (example, silicone, polymethylmethacrylate (PMMA)) in the lower face and/or jawline area or plans to receive such treatments during participation in the study.\n2. Been treated with semi-permanent dermal fillers (example, poly L-lactic acid) in the lower face and/or jawline area in the past 5 years or plans to receive such treatments during participation in the study.'}, 'identificationModule': {'nctId': 'NCT03583359', 'briefTitle': 'Evaluation of Effectiveness and Safety of Radiesse (+) to Improve the Contour of Jawline by Adding Volume to the Jawline', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merz North America, Inc.'}, 'officialTitle': 'Evaluation of Effectiveness and Safety of Radiesse (+) to Improve the Contour of Jawline by Adding Volume to the Jawline', 'orgStudyIdInfo': {'id': 'M900391004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment with Radiesse (+)', 'interventionNames': ['Device: Radiesse (+)']}, {'type': 'OTHER', 'label': 'Control/Delayed Treatment with Radiesse (+)', 'interventionNames': ['Device: Radiesse (+)']}], 'interventions': [{'name': 'Radiesse (+)', 'type': 'DEVICE', 'otherNames': ['Radiesse (+) Injectable Dermal Filler with Lidocaine'], 'description': 'Radiesse (+) for jawlines.', 'armGroupLabels': ['Control/Delayed Treatment with Radiesse (+)', 'Treatment with Radiesse (+)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90210', 'city': 'Beverly Hills', 'state': 'California', 'country': 'United States', 'facility': 'Clinical Testing of Beverly Hills, Merz Investigational Site #0010395', 'geoPoint': {'lat': 34.07362, 'lon': -118.40036}}, {'zip': '90069', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Skin Care Center, Merz Investigational Site #0010099', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90404', 'city': 'Santa Monica', 'state': 'California', 'country': 'United States', 'facility': 'Ava MD, Merz Investigational Site #0010299', 'geoPoint': {'lat': 34.01949, 'lon': -118.49138}}, {'zip': '92083', 'city': 'Vista', 'state': 'California', 'country': 'United States', 'facility': 'Moradi MD Face Beautiful Inc, Merz Investigational Site #0010358', 'geoPoint': {'lat': 33.20004, 'lon': -117.24254}}, {'zip': '80111', 'city': 'Greenwood Village', 'state': 'Colorado', 'country': 'United States', 'facility': 'AboutSkin Research LLC, Merz Investigational Site #0010103', 'geoPoint': {'lat': 39.61721, 'lon': -104.95081}}, {'zip': '33146', 'city': 'Coral Gables', 'state': 'Florida', 'country': 'United States', 'facility': 'Skin Research Institute, Merz Investigational Site #0010101', 'geoPoint': {'lat': 25.72149, 'lon': -80.26838}}, {'zip': '33401', 'city': 'West Palm Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Institute of the Southeast, LLC, Merz Investigational Site #0010420', 'geoPoint': {'lat': 26.71534, 'lon': -80.05337}}, {'zip': '70124', 'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Lupo Center for Aesthetic and General Dermatology, Merz Investigational Site #0010418', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'zip': '21030', 'city': 'Hunt Valley', 'state': 'Maryland', 'country': 'United States', 'facility': 'MD Laser Skin & Vein Institute, Merz Investigational Site #0010323', 'geoPoint': {'lat': 39.49983, 'lon': -76.64108}}, {'zip': '02467', 'city': 'Chestnut Hill', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'SkinCare Physicians of Chestnut Hill. Merz Investigational #0010098', 'geoPoint': {'lat': 42.33065, 'lon': -71.16616}}, {'zip': '10028', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Skinfluence Medical PC, Merz Investigational #0010421', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10065', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Bass Plastic Surgery PLLC, Merz Investigational Site #0010419', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '28207', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Dermatology, Laser & Vein Specialists of the Carolinas, Merz Investigational Site #0010194', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '29407', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Clinical Research Center of the Carolinas, Merz Investigational Site #0010417', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '78746', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Westlake Dermatology, Merz Investigational Site #0010322', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}], 'overallOfficials': [{'name': 'Merz Medical Expert', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merz North America, Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merz North America, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}