Ignite Creation Date:
2025-12-25 @ 2:26 AM
Ignite Modification Date:
2025-12-27 @ 6:59 AM
Study NCT ID:
NCT01629134
Status:
COMPLETED
Last Update Posted:
2014-10-13
First Post:
2012-06-25
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Postmarket Study of JUVÉDERM VOLBELLA™ With Lidocaine in the Lips
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@allergan.com', 'phone': '714-246-4500', 'title': 'Medical Monitor', 'organization': 'Allergan, Inc.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Volbella', 'description': "Subjects treated with JUVÉDERM VOLBELLA™ according to the physician's experience and Directions for Use\n\nCrosslinked hyaluronic acid gel : All treatments are carried out according to the physician's experience and the Directions for Use", 'otherNumAtRisk': 62, 'otherNumAffected': 0, 'seriousNumAtRisk': 62, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Subject Rating of the Natural Look and Feel of the Lips', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Volbella', 'description': "Subjects treated with JUVÉDERM VOLBELLA™ according to the physician's experience and Directions for Use\n\nCrosslinked hyaluronic acid gel : All treatments are carried out according to the physician's experience and the Directions for Use"}], 'classes': [{'title': 'Extremely natural', 'categories': [{'measurements': [{'value': '52.5', 'groupId': 'OG000'}]}]}, {'title': 'Very natural', 'categories': [{'measurements': [{'value': '35.6', 'groupId': 'OG000'}]}]}, {'title': 'Slightly natural', 'categories': [{'measurements': [{'value': '11.9', 'groupId': 'OG000'}]}]}, {'title': 'Not natural', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '4 weeks', 'description': 'Percentage of subjects rating the look and feel of their lips as being extremely natural, very natural, slightly natural, and not natural.', 'unitOfMeasure': 'Percentage of subjects', 'populationDescription': 'All subjects who met the criteria and treatment was initiated'}, {'type': 'PRIMARY', 'title': 'Injector Rating of the Natural Look and Feel of the Lips', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Volbella', 'description': "Subjects treated with JUVÉDERM VOLBELLA™ according to the physician's experience and Directions for Use\n\nCrosslinked hyaluronic acid gel : All treatments are carried out according to the physician's experience and the Directions for Use"}], 'classes': [{'title': 'Extremely natural', 'categories': [{'measurements': [{'value': '45.9', 'groupId': 'OG000'}]}]}, {'title': 'Very natural', 'categories': [{'measurements': [{'value': '54.1', 'groupId': 'OG000'}]}]}, {'title': 'Slightly natural', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Not natural', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '4 weeks', 'description': "Percentage of injectors who rated the look and feel of subjects' lips as being extremely natural, very natural, slightly natural, and not natural.", 'unitOfMeasure': 'Percentage of subjects', 'populationDescription': 'All subjects who met the criteria and treatment was initiated'}, {'type': 'SECONDARY', 'title': 'Bruising of the Lips', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Volbella', 'description': "Subjects treated with JUVÉDERM VOLBELLA™ according to the physician's experience and Directions for Use\n\nCrosslinked hyaluronic acid gel : All treatments are carried out according to the physician's experience and the Directions for Use"}], 'classes': [{'title': 'None', 'categories': [{'measurements': [{'value': '85.5', 'groupId': 'OG000'}]}]}, {'title': 'Little', 'categories': [{'measurements': [{'value': '12.9', 'groupId': 'OG000'}]}]}, {'title': 'Some', 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000'}]}]}, {'title': 'Moderate', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Considerable', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '15 minutes after injection', 'description': "Injector assessment of whether there was none, little, some, moderate, or considerable bruising in subjects' lips", 'unitOfMeasure': 'Percentage of subjects', 'populationDescription': 'All subjects who met the criteria and treatment was initiated'}, {'type': 'SECONDARY', 'title': 'Swelling of the Lips', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Volbella', 'description': "Subjects treated with JUVÉDERM VOLBELLA™ according to the physician's experience and Directions for Use\n\nCrosslinked hyaluronic acid gel : All treatments are carried out according to the physician's experience and the Directions for Use"}], 'classes': [{'title': 'None', 'categories': [{'measurements': [{'value': '38.7', 'groupId': 'OG000'}]}]}, {'title': 'Little', 'categories': [{'measurements': [{'value': '53.2', 'groupId': 'OG000'}]}]}, {'title': 'Some', 'categories': [{'measurements': [{'value': '8.1', 'groupId': 'OG000'}]}]}, {'title': 'Moderate', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Considerable', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '15 minutes after injection', 'description': "Injector assessment of whether there was none, little, some, moderate, or considerable swelling in subjects' lips", 'unitOfMeasure': 'Percentage of subjects', 'populationDescription': 'All subjects who met the criteria and treatment was initiated'}, {'type': 'SECONDARY', 'title': 'Ease of Injection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Volbella', 'description': "Subjects treated with JUVÉDERM VOLBELLA™ according to the physician's experience and Directions for Use\n\nCrosslinked hyaluronic acid gel : All treatments are carried out according to the physician's experience and the Directions for Use"}], 'classes': [{'title': 'Score of 0', 'categories': [{'measurements': [{'value': '54.8', 'groupId': 'OG000'}]}]}, {'title': 'Score of 1', 'categories': [{'measurements': [{'value': '45.2', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '15 minutes after injection', 'description': 'Injectors rated the ease of injection on a scale ranging from 0 (Very easy) to 10 (Extremely difficult)', 'unitOfMeasure': 'Percentage of subjects', 'populationDescription': 'All subjects who met the criteria and treatment was initiated'}, {'type': 'SECONDARY', 'title': 'Malleability of Product', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Volbella', 'description': "Subjects treated with JUVÉDERM VOLBELLA™ according to the physician's experience and Directions for Use\n\nCrosslinked hyaluronic acid gel : All treatments are carried out according to the physician's experience and the Directions for Use"}], 'classes': [{'title': 'Score of 0', 'categories': [{'measurements': [{'value': '45.2', 'groupId': 'OG000'}]}]}, {'title': 'Score of 1', 'categories': [{'measurements': [{'value': '54.8', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '15 minutes after injection', 'description': 'Injectors rated the malleability on a scale ranging from 0 (Extremely malleable/Not hard to mold) to 10 (Not malleable/Hard to mold)', 'unitOfMeasure': 'Percentage of subjects', 'populationDescription': 'All subjects who met the criteria and treatment was initiated'}, {'type': 'SECONDARY', 'title': 'Need for Massage', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Volbella', 'description': "Subjects treated with JUVÉDERM VOLBELLA™ according to the physician's experience and Directions for Use\n\nCrosslinked hyaluronic acid gel : All treatments are carried out according to the physician's experience and the Directions for Use"}], 'classes': [{'title': 'None/minimal', 'categories': [{'measurements': [{'value': '41.9', 'groupId': 'OG000'}]}]}, {'title': 'A little', 'categories': [{'measurements': [{'value': '58.1', 'groupId': 'OG000'}]}]}, {'title': 'Some', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'A lot', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '15 minutes after injection', 'description': 'Injectors rated whether none/minimal, a little, some, or a lot of massage was required to optimize placement of VOLBELLA', 'unitOfMeasure': 'Percentage of subjects', 'populationDescription': 'All subjects who met the criteria and treatment was initiated'}, {'type': 'SECONDARY', 'title': 'Return to Social Engagement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Volbella', 'description': "Subjects treated with JUVÉDERM VOLBELLA™ according to the physician's experience and Directions for Use\n\nCrosslinked hyaluronic acid gel : All treatments are carried out according to the physician's experience and the Directions for Use"}], 'classes': [{'title': '< 1 Day (same day)', 'categories': [{'measurements': [{'value': '62.3', 'groupId': 'OG000'}]}]}, {'title': '1 Day (next day)', 'categories': [{'measurements': [{'value': '19.7', 'groupId': 'OG000'}]}]}, {'title': '2-3 Days', 'categories': [{'measurements': [{'value': '9.8', 'groupId': 'OG000'}]}]}, {'title': '4-5 Days', 'categories': [{'measurements': [{'value': '8.2', 'groupId': 'OG000'}]}]}, {'title': '> 6 Days', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '4 weeks', 'description': 'Time to return to normal daily activities', 'unitOfMeasure': 'Percentage of subjects', 'populationDescription': 'All subjects who met the criteria and treatment was initiated'}, {'type': 'SECONDARY', 'title': 'Comparative Rating With Previous Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Volbella', 'description': "Subjects treated with JUVÉDERM VOLBELLA™ according to the physician's experience and Directions for Use\n\nCrosslinked hyaluronic acid gel : All treatments are carried out according to the physician's experience and the Directions for Use"}], 'classes': [{'title': 'Significantly better', 'categories': [{'measurements': [{'value': '46.2', 'groupId': 'OG000'}]}]}, {'title': 'Somewhat better', 'categories': [{'measurements': [{'value': '53.8', 'groupId': 'OG000'}]}]}, {'title': 'No difference', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Somewhat worse', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Significantly worse', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '15 minutes after injection', 'description': 'Subject rating of lip improvement with VOLBELLA compared with previous lip enhancement treatments as significantly better, somewhat better, no difference, somewhat worse, or significantly worse', 'unitOfMeasure': 'Percentage of subjects', 'populationDescription': 'All subjects who met the criteria and treatment was initiated'}, {'type': 'SECONDARY', 'title': 'Rating of Injection Discomfort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Volbella', 'description': "Subjects treated with JUVÉDERM VOLBELLA™ according to the physician's experience and Directions for Use\n\nCrosslinked hyaluronic acid gel : All treatments are carried out according to the physician's experience and the Directions for Use"}], 'classes': [{'categories': [{'measurements': [{'value': '1.3', 'spread': '1.5', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '15 minutes after injection', 'description': 'The level of discomfort during treatment on a scale of 0 (no discomfort) to 10 (extreme discomfort).', 'unitOfMeasure': 'scale score', 'dispersionType': 'Standard Deviation', 'populationDescription': 'All subjects who met the criteria and treatment was initiated'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Volbella', 'description': "Subjects treated with JUVÉDERM VOLBELLA™ according to the physician's experience and Directions for Use\n\nCrosslinked hyaluronic acid gel : All treatments are carried out according to the physician's experience and the Directions for Use"}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '62'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '62'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Volbella', 'description': "Subjects treated with JUVÉDERM VOLBELLA™ according to the physician's experience and Directions for Use\n\nCrosslinked hyaluronic acid gel : All treatments are carried out according to the physician's experience and the Directions for Use"}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '59', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '39.7', 'spread': '12.6', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '55', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Germany', 'categories': [{'measurements': [{'value': '62', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 62}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-10', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-10-03', 'studyFirstSubmitDate': '2012-06-25', 'resultsFirstSubmitDate': '2013-03-21', 'studyFirstSubmitQcDate': '2012-06-26', 'lastUpdatePostDateStruct': {'date': '2014-10-13', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-03-21', 'studyFirstPostDateStruct': {'date': '2012-06-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-05-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Subject Rating of the Natural Look and Feel of the Lips', 'timeFrame': '4 weeks', 'description': 'Percentage of subjects rating the look and feel of their lips as being extremely natural, very natural, slightly natural, and not natural.'}, {'measure': 'Injector Rating of the Natural Look and Feel of the Lips', 'timeFrame': '4 weeks', 'description': "Percentage of injectors who rated the look and feel of subjects' lips as being extremely natural, very natural, slightly natural, and not natural."}], 'secondaryOutcomes': [{'measure': 'Bruising of the Lips', 'timeFrame': '15 minutes after injection', 'description': "Injector assessment of whether there was none, little, some, moderate, or considerable bruising in subjects' lips"}, {'measure': 'Swelling of the Lips', 'timeFrame': '15 minutes after injection', 'description': "Injector assessment of whether there was none, little, some, moderate, or considerable swelling in subjects' lips"}, {'measure': 'Ease of Injection', 'timeFrame': '15 minutes after injection', 'description': 'Injectors rated the ease of injection on a scale ranging from 0 (Very easy) to 10 (Extremely difficult)'}, {'measure': 'Malleability of Product', 'timeFrame': '15 minutes after injection', 'description': 'Injectors rated the malleability on a scale ranging from 0 (Extremely malleable/Not hard to mold) to 10 (Not malleable/Hard to mold)'}, {'measure': 'Need for Massage', 'timeFrame': '15 minutes after injection', 'description': 'Injectors rated whether none/minimal, a little, some, or a lot of massage was required to optimize placement of VOLBELLA'}, {'measure': 'Return to Social Engagement', 'timeFrame': '4 weeks', 'description': 'Time to return to normal daily activities'}, {'measure': 'Comparative Rating With Previous Treatment', 'timeFrame': '15 minutes after injection', 'description': 'Subject rating of lip improvement with VOLBELLA compared with previous lip enhancement treatments as significantly better, somewhat better, no difference, somewhat worse, or significantly worse'}, {'measure': 'Rating of Injection Discomfort', 'timeFrame': '15 minutes after injection', 'description': 'The level of discomfort during treatment on a scale of 0 (no discomfort) to 10 (extreme discomfort).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Lip Augmentation']}, 'referencesModule': {'references': [{'pmid': '24910276', 'type': 'RESULT', 'citation': 'Philipp-Dormston WG, Hilton S, Nathan M. A prospective, open-label, multicenter, observational, postmarket study of the use of a 15 mg/mL hyaluronic acid dermal filler in the lips. J Cosmet Dermatol. 2014 Jun;13(2):125-34. doi: 10.1111/jocd.12085.'}]}, 'descriptionModule': {'briefSummary': 'A prospective, multicenter postmarket study of the use of JUVÉDERM VOLBELLA™ with Lidocaine in the lips.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy volunteers desiring lip augmentation', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Desire and willingness for correction of asymmetry or volume enhancement of his/her lips\n* Females and males ≥ 18 years of age\n* Have established a realistic treatment goal that the Physician agrees is achievable, i.e., have realistic expectations of aesthetic results\n\nExclusion Criteria:\n\n* Not fulfilling the standard prescribing criteria for JUVÉDERM VOLBELLA™ with Lidocaine as detailed in the Directions for Use\n* Have a condition or be in a situation that, in the Physician's opinion, may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study"}, 'identificationModule': {'nctId': 'NCT01629134', 'briefTitle': 'Postmarket Study of JUVÉDERM VOLBELLA™ With Lidocaine in the Lips', 'organization': {'class': 'INDUSTRY', 'fullName': 'Allergan'}, 'orgStudyIdInfo': {'id': 'MAF/AGN/MED/FIL/019'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Volbella', 'description': "Subjects treated with JUVÉDERM VOLBELLA™ according to the physician's experience and Directions for Use", 'interventionNames': ['Device: Crosslinked hyaluronic acid gel']}], 'interventions': [{'name': 'Crosslinked hyaluronic acid gel', 'type': 'DEVICE', 'otherNames': ['JUVÉDERM VOLBELLA™'], 'description': "All treatments are carried out according to the physician's experience and the Directions for Use", 'armGroupLabels': ['Volbella']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Düsseldorf', 'state': 'North Rhine-Westphalia', 'country': 'Germany', 'geoPoint': {'lat': 51.22172, 'lon': 6.77616}}], 'overallOfficials': [{'name': 'Medical Monitor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Allergan Medical'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Allergan Medical', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}