Ignite Creation Date:
2025-12-25 @ 3:08 AM
Ignite Modification Date:
2025-12-26 @ 1:47 AM
Study NCT ID:
NCT01579305
Status:
COMPLETED
Last Update Posted:
2019-01-17
First Post:
2012-04-16
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Safety and Effectiveness of Juvéderm® Volbella With Lidocaine Versus Restylane-L® for Lip Volume Enhancement
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'devicetrials@allergan.com', 'phone': '805 961 5000', 'title': 'Medical Monitor', 'organization': 'Allergan, Inc.'}, 'certainAgreement': {'otherDetails': 'Allergan, as the Sponsor, has proprietary interest in this study. Authorship and manuscript composition will reflect joint cooperation between multiple Investigators and sites and Allergan personnel. Authorship will be established prior to the writing of the manuscript. As this study involves multiple centers, no individual publications will be allowed prior to completion of the final report of the multicenter study except as agreed with Allergan.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Subjects Treated With VOLBELLA®', 'otherNumAtRisk': 139, 'otherNumAffected': 27, 'seriousNumAtRisk': 139, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Subjects Treated With Restylane-L®', 'otherNumAtRisk': 141, 'otherNumAffected': 26, 'seriousNumAtRisk': 141, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Injection site mass', 'notes': 'lumps/bumps', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 141, 'numAffected': 12}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 141, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Oral herpes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 141, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}], 'seriousEvents': [{'term': 'Tendon rupture', 'notes': 'This event was classified as not related to the anesthesia, study device, or procedure, and resolved without sequelae after treatment with medication and a procedure.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 141, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Breast cancer', 'notes': 'This event was classified as not related to the anesthesia, study device, or procedure, and resolved with sequelae after treatment with a procedure.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 141, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': "Month 3 Overall Lip Fullness Scale Responder Rate Based on Independent Central Reviewer's Assessment", 'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Subjects Randomized to Receive VOLBELLA® and Treated'}, {'id': 'OG001', 'title': 'Subjects Randomized to Receive Restylane-L® and Treated'}], 'classes': [{'categories': [{'measurements': [{'value': '34.1', 'groupId': 'OG000', 'lowerLimit': '25.77', 'upperLimit': '42.53'}, {'value': '29.3', 'groupId': 'OG001', 'lowerLimit': '21.23', 'upperLimit': '37.31'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in responder rates', 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '97.5', 'paramValue': '4.9', 'ciLowerLimit': '-6.7', 'estimateComment': 'Difference in responder rates is calculated as the responder rate at Month 3 for VOLBELLA® minus the responder rate at Month 3 for Restylane-L®.', 'groupDescription': 'The null hypothesis is that VOLBELLA® is inferior to Restylane-L® in terms of responder rate at Month 3, and the alternative hypothesis is that VOLBELLA® is inferior to Restylane-L® in terms of responder rate at Month 3 with 15% pre-defined non-inferiority margin. To test the null hypothesis, a difference in responder rates of these products (VOLBELLA® - Restylane-L®) at Month 3 and a 1-sided 97.5% Wald confidence interval for the difference is calculated.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'The non-inferiority margin is pre-defined as 15% i.e., if the difference in responder rates is significantly greater than -15% (i.e., the lower confidence limit is greater than -15%), statistical non-inferiority of VOLBELLA® to Restylane-L® is established.'}], 'paramType': 'NUMBER', 'timeFrame': '3 months', 'description': 'The primary effectiveness variable is the responder rate (percentage of subjects who show ≥ 1-point improvement on the 5-point Lip Fullness Scale (Minimal, Mild, Moderate, Marked, Very Marked) compared to baseline assessment, as determined by Independent Central Reviewer evaluation of 3D photographic images).', 'unitOfMeasure': 'Percentage of subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-protocol population (all subjects who are randomized, received at least 1 study treatment, and have no protocol deviations that affect the primary effectiveness endpoint)'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Subject Randomized to Receive VOLBELLA®'}, {'id': 'FG001', 'title': 'Subjects Randomized to Receive Restylane-L®'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Subjects that signed Informed Consent, passed screening criteria, and were randomized.', 'groupId': 'FG000', 'numSubjects': '139'}, {'comment': 'Subjects that signed Informed Consent, passed screening criteria, and were randomized.', 'groupId': 'FG001', 'numSubjects': '142'}]}, {'type': 'Discontinued Before Treatment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Continued After Treatment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '139'}, {'groupId': 'FG001', 'numSubjects': '141'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '118'}, {'groupId': 'FG001', 'numSubjects': '115'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '27'}]}]}], 'preAssignmentDetails': 'Enrollment was defined as having signed the IRB-approved Informed Consent Form. Prior to randomization, 4 subjects were excluded as screen fails, leaving an "Intent-to-Treat" population of 281 subjects.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'BG000'}, {'value': '141', 'groupId': 'BG001'}, {'value': '280', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Subjects Randomized to Receive VOLBELLA®'}, {'id': 'BG001', 'title': 'Subjects Randomized to Receive Restylane-L®'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '47.1', 'spread': '11.94', 'groupId': 'BG000'}, {'value': '48.3', 'spread': '12.61', 'groupId': 'BG001'}, {'value': '47.7', 'spread': '12.28', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '135', 'groupId': 'BG000'}, {'value': '139', 'groupId': 'BG001'}, {'value': '274', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'France', 'categories': [{'measurements': [{'value': '48', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '97', 'groupId': 'BG002'}]}]}, {'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '91', 'groupId': 'BG000'}, {'value': '92', 'groupId': 'BG001'}, {'value': '183', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Baseline characteristics are based on the "modified Intent-to-Treat" population: subjects randomized to receive treatment and treated.'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 285}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-09', 'studyFirstSubmitDate': '2012-04-16', 'resultsFirstSubmitDate': '2014-06-27', 'studyFirstSubmitQcDate': '2012-04-16', 'lastUpdatePostDateStruct': {'date': '2019-01-17', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2014-07-10', 'studyFirstPostDateStruct': {'date': '2012-04-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-08-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Month 3 Overall Lip Fullness Scale Responder Rate Based on Independent Central Reviewer's Assessment", 'timeFrame': '3 months', 'description': 'The primary effectiveness variable is the responder rate (percentage of subjects who show ≥ 1-point improvement on the 5-point Lip Fullness Scale (Minimal, Mild, Moderate, Marked, Very Marked) compared to baseline assessment, as determined by Independent Central Reviewer evaluation of 3D photographic images).'}]}, 'conditionsModule': {'conditions': ['Lip Volume Enhancement']}, 'referencesModule': {'references': [{'pmid': '25878932', 'type': 'BACKGROUND', 'citation': 'Raspaldo H, Chantrey J, Belhaouari L, Saleh R, Murphy DK. Juvederm volbella with lidocaine for lip and perioral enhancement: a prospective, randomized, controlled trial. Plast Reconstr Surg Glob Open. 2015 Apr 7;3(3):e321. doi: 10.1097/GOX.0000000000000266. eCollection 2015 Mar.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is evaluate lip fullness 3 months following treatment with Juvéderm® Volbella with Lidocaine or Restylane-L®'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Desire enhancement of his/her vermilion borders and/or vermilion mucosa\n2. Have a baseline score of Minimal or Mild, as assessed by the Investigator, according to the 5-point LFS (Minimal, Mild, Moderate, Marked, Very Marked)\n3. Have established a realistic Lip Fullness treatment goal that the Investigator agrees is achievable\n\nExclusion Criteria:\n\n1. Have undergone cosmetic facial, lip or perioral procedures \\[e.g., face-lift, or other surgeries, which may alter the appearance of the lips or perioral area (laser, photomodulation, intense pulsed light, radio frequency, dermabrasion, moderate or greater depth chemical peel, or other ablative procedures), tissue augmentation with dermal fillers or fat injections, or mesotherapy\\] anywhere in the face or neck, or Botox® Cosmetic injections in the lower face (below the orbital rim), within 6 months prior to entry in the study or be planning to undergo any of these procedures at any time during the study. NOTE: Prior treatment with HA fillers and/or collagen is allowed, provided the treatment was administered more than 6 months prior to study entry\n2. Have ever received semi-permanent fillers or permanent facial implants, e.g., calcium hydroxyapatite, L-polylactic acid, polymethylmethacrylate (PMMA), silicone, expanded polytetrafluoroethylene (ePTFE) anywhere in the lips, or be planning to be implanted with any of these products at any time during the study'}, 'identificationModule': {'nctId': 'NCT01579305', 'briefTitle': 'Safety and Effectiveness of Juvéderm® Volbella With Lidocaine Versus Restylane-L® for Lip Volume Enhancement', 'organization': {'class': 'INDUSTRY', 'fullName': 'Allergan'}, 'orgStudyIdInfo': {'id': 'S15L-003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Juvéderm® Volbella with Lidocaine', 'description': 'Subjects injected with Juvéderm® Volbella with Lidocaine in their lips', 'interventionNames': ['Device: Juvéderm® Volbella with Lidocaine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Restylane-L®', 'description': 'Subjects injected with Restylane-L® in their lips', 'interventionNames': ['Device: Restylane-L®']}], 'interventions': [{'name': 'Juvéderm® Volbella with Lidocaine', 'type': 'DEVICE', 'description': 'Up to 4.0 mL at the discretion of the Investigator to achieve optimal results', 'armGroupLabels': ['Juvéderm® Volbella with Lidocaine']}, {'name': 'Restylane-L®', 'type': 'DEVICE', 'description': 'Up to 4.0 mL at the discretion of the Investigator to achieve optimal results', 'armGroupLabels': ['Restylane-L®']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cannes', 'country': 'France', 'geoPoint': {'lat': 43.55135, 'lon': 7.01275}}, {'city': 'Glasgow', 'country': 'United Kingdom', 'geoPoint': {'lat': 55.86515, 'lon': -4.25763}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Allergan Medical', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}