Ignite Creation Date:
2025-12-24 @ 4:31 PM
Ignite Modification Date:
2025-12-28 @ 2:35 PM
Study NCT ID:
NCT03438266
Status:
COMPLETED
Last Update Posted:
2019-08-05
First Post:
2018-02-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of the Safety and Effectiveness of JUVÉDERM VOLUMA® XC Injectable Gel for Cheek Augmentation Using Cannula
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000072601', 'term': 'Cannula'}, {'id': 'D009339', 'term': 'Needles'}], 'ancestors': [{'id': 'D057785', 'term': 'Catheters'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@allergan.com', 'phone': '714-246-4500', 'title': 'Therapeutic Area, Head', 'organization': 'Allergan'}, 'certainAgreement': {'otherDetails': 'A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to 3 months', 'description': 'The data for adverse events is reported by participant because both treatments were received at the same time and it included both treatment-related and non-treatment-related adverse events.', 'eventGroups': [{'id': 'EG000', 'title': 'JUVÉDERM VOLUMA® XC (All Participants)', 'description': 'Participants had 1 cheek treated with JUVÉDERM VOLUMA® XC injectable gel with cannula and 1 cheek treated with JUVÉDERM VOLUMA® XC injectable gel with a needle.', 'otherNumAtRisk': 60, 'deathsNumAtRisk': 60, 'otherNumAffected': 3, 'seriousNumAtRisk': 60, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Mid-Face Volume Deficit Scale (MFVDS) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'JUVÉDERM VOLUMA® XC Injectable Gel With Cannula', 'description': 'Participants had 1 cheek treated with JUVÉDERM VOLUMA® XC injectable gel with cannula.'}, {'id': 'OG001', 'title': 'JUVÉDERM VOLUMA® XC Injectable Gel With Needle', 'description': 'Participants had 1 cheek treated with JUVÉDERM VOLUMA® XC injectable gel with a needle.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '3.5', 'spread': '0.62', 'groupId': 'OG000'}, {'value': '3.5', 'spread': '0.62', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Month 1', 'categories': [{'measurements': [{'value': '-1.8', 'spread': '1.03', 'groupId': 'OG000'}, {'value': '-1.9', 'spread': '0.96', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.1', 'ciLowerLimit': '-0.05', 'ciUpperLimit': '0.25', 'estimateComment': 'The 95% CI is based on the paired t-test.', 'groupDescription': 'Change from Baseline at Month 1', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'If the upper limit of the confidence interval at Month 1 was less than 0.5, then treatment with cannula was considered non-inferior to treatment with needle.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Screening) to Month 1', 'description': "The evaluating investigator (EI) assessed the participant's overall mid-face volume deficit for each cheek using a 6-point photonumeric scale, where: 0=None (moon face; fullness) \\[best\\] to 5=Severe (wasting) \\[worst\\]. A negative change from Baseline indicates improvement.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population included all randomized participants who received treatment with cannula on 1 cheek and treatment with needle on the contralateral (other) cheek.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With at Least a 1-Point Improvement (Decrease From Baseline) in MFVDS Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'JUVÉDERM VOLUMA® XC Injectable Gel With Cannula', 'description': 'Participants had 1 cheek treated with JUVÉDERM VOLUMA® XC injectable gel with cannula.'}, {'id': 'OG001', 'title': 'JUVÉDERM VOLUMA® XC Injectable Gel With Needle', 'description': 'Participants had 1 cheek treated with JUVÉDERM VOLUMA® XC injectable gel with a needle.'}], 'classes': [{'categories': [{'measurements': [{'value': '93.3', 'groupId': 'OG000', 'lowerLimit': '83.80', 'upperLimit': '98.15'}, {'value': '95.0', 'groupId': 'OG001', 'lowerLimit': '86.08', 'upperLimit': '98.96'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Percentage Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.7', 'ciLowerLimit': '-7.31', 'ciUpperLimit': '3.98', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (Screening) to Month 1', 'description': "The EI assessed the participant's overall mid-face volume deficit for each cheek using a 6-point photonumeric scale, where: 0=None (moon face; fullness) \\[best\\] to 5=Severe (wasting) \\[worst\\]. The percentage of participants who showed ≥1-point improvement (decrease in severity) from Baseline is reported.", 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population included all randomized participants who received treatment with cannula on 1 cheek and treatment with needle on the contralateral (other) cheek.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in FACE-Q Satisfaction With Cheeks Questionnaire Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'JUVÉDERM VOLUMA® XC (All Participants)', 'description': 'Participants had 1 cheek treated with JUVÉDERM VOLUMA® XC injectable gel with cannula and 1 cheek treated with JUVÉDERM VOLUMA® XC injectable gel with a needle.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '32.1', 'spread': '15.62', 'groupId': 'OG000'}]}]}, {'title': 'Change from Baseline at Month 1', 'categories': [{'measurements': [{'value': '55.5', 'spread': '25.06', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Screening) to Month 1', 'description': 'The participant completed the 5-item Satisfaction with Cheeks module of the FACE-Q questionnaire that evaluated various aspects of the cheeks including symmetry, smoothness, attractiveness, contour, and fullness using a 4-point scale where: 1=very dissatisfied to 4=very satisfied. The total score was transformed to a 0 to 100 point scale, with higher scores indicating greater satisfaction. A positive change from Baseline indicates improvement. The FACE-Q Satisfaction with Cheeks outcome was assessed by the participant overall and not by each cheek.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population included all randomized participants who received treatment with cannula on 1 cheek and treatment with needle on the contralateral (other) cheek. FACE-Q is a global assessment and was administered per participant.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment-Emergent Adverse Events (TEAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'JUVÉDERM VOLUMA® XC (All Participants)', 'description': 'Participants had 1 cheek treated with JUVÉDERM VOLUMA® XC injectable gel with cannula and 1 cheek treated with JUVÉDERM VOLUMA® XC injectable gel with a needle.'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 3 months', 'description': 'An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. A TEAE is defined as an AE that initially occurred or increased in severity on or after the treatment start date.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all randomized participants who received at least 1 study treatment. The data for adverse events is reported by participant because both treatments were received at the same time and it included both treatment-related and non-treatment-related adverse events.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'JUVÉDERM VOLUMA® XC (All Participants)', 'description': 'Participants had 1 cheek treated with JUVÉDERM VOLUMA® XC injectable gel with cannula and 1 cheek treated with JUVÉDERM VOLUMA® XC injectable gel with a needle.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '60'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '60'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'A total of 66 participants were enrolled in the study and 6 were excluded as screen failures. Only 60 participants were randomized and received study treatment.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'BG000'}]}, {'units': 'Cheeks', 'counts': [{'value': '120', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'JUVÉDERM VOLUMA® XC (All Participants)', 'description': 'Participants had 1 cheek treated with JUVÉDERM VOLUMA® XC injectable gel with cannula and 1 cheek treated with JUVÉDERM VOLUMA® XC injectable gel with a needle.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '54.9', 'spread': '6.41', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION', 'denomUnitsSelected': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '49', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'denomUnitsSelected': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'categories': [{'title': 'White', 'measurements': [{'value': '59', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'denomUnitsSelected': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '53', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'denomUnitsSelected': 'Participants'}], 'typeUnitsAnalyzed': 'Cheeks', 'populationDescription': 'Modified Intent-to-Treat (mITT) population included all randomized participants who received treatment with cannula on 1 cheek and treatment with needle on the contralateral (other) cheek.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-10-19', 'size': 703467, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-05-29T23:56', 'hasProtocol': True}, {'date': '2018-07-13', 'size': 600084, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2019-05-29T23:56', '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': 66}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-02-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2018-08-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-01', 'studyFirstSubmitDate': '2018-02-05', 'resultsFirstSubmitDate': '2019-05-29', 'studyFirstSubmitQcDate': '2018-02-16', 'lastUpdatePostDateStruct': {'date': '2019-08-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-08-01', 'studyFirstPostDateStruct': {'date': '2018-02-19', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2019-08-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-05-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Mid-Face Volume Deficit Scale (MFVDS) Score', 'timeFrame': 'Baseline (Screening) to Month 1', 'description': "The evaluating investigator (EI) assessed the participant's overall mid-face volume deficit for each cheek using a 6-point photonumeric scale, where: 0=None (moon face; fullness) \\[best\\] to 5=Severe (wasting) \\[worst\\]. A negative change from Baseline indicates improvement."}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With at Least a 1-Point Improvement (Decrease From Baseline) in MFVDS Score', 'timeFrame': 'Baseline (Screening) to Month 1', 'description': "The EI assessed the participant's overall mid-face volume deficit for each cheek using a 6-point photonumeric scale, where: 0=None (moon face; fullness) \\[best\\] to 5=Severe (wasting) \\[worst\\]. The percentage of participants who showed ≥1-point improvement (decrease in severity) from Baseline is reported."}, {'measure': 'Change From Baseline in FACE-Q Satisfaction With Cheeks Questionnaire Score', 'timeFrame': 'Baseline (Screening) to Month 1', 'description': 'The participant completed the 5-item Satisfaction with Cheeks module of the FACE-Q questionnaire that evaluated various aspects of the cheeks including symmetry, smoothness, attractiveness, contour, and fullness using a 4-point scale where: 1=very dissatisfied to 4=very satisfied. The total score was transformed to a 0 to 100 point scale, with higher scores indicating greater satisfaction. A positive change from Baseline indicates improvement. The FACE-Q Satisfaction with Cheeks outcome was assessed by the participant overall and not by each cheek.'}, {'measure': 'Number of Participants With Treatment-Emergent Adverse Events (TEAEs)', 'timeFrame': 'Up to 3 months', 'description': 'An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. A TEAE is defined as an AE that initially occurred or increased in severity on or after the treatment start date.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Age-related Volume Deficit in the Mid-face']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.allerganclinicaltrials.com/', 'label': 'Additional information on study locations near you may be found at AllerganClinicalTrials.com. For any study not on AllerganClinicalTrials.com, please contact IR-CTRegistration@Allergan.com for assistance.'}]}, 'descriptionModule': {'briefSummary': 'The objective of this study is to evaluate the safety and effectiveness of JUVÉDERM VOLUMA® XC injectable gel using cannula in participants seeking correction of age-related volume deficit in the mid-face.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '35 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nMale or female aged 35 to 65 (inclusive) years of age with overall mid-face severity of Moderate, Significant, or Severe for both cheeks on the Mid-Face Volume Deficit Scale (MFVDS);\n\nExclusion criteria:\n\n* Has any facial procedures or trauma that may interfere with the study procedures and results;\n* Has a history of anaphylaxis or allergy to lidocaine (or any amide-based anesthetics), hyaluronic acid (HA) products, or Streptococcal protein, or is planning to undergo allergen desensitization therapy during the term of the study;\n* Has active autoimmune disease;\n* Has current cutaneous or mucosal inflammatory or infectious processes.'}, 'identificationModule': {'nctId': 'NCT03438266', 'briefTitle': 'A Study of the Safety and Effectiveness of JUVÉDERM VOLUMA® XC Injectable Gel for Cheek Augmentation Using Cannula', 'organization': {'class': 'INDUSTRY', 'fullName': 'Allergan'}, 'officialTitle': 'A Multicenter, Single-blind, Randomized, Controlled Study of the Safety and Effectiveness of JUVÉDERM VOLUMA® XC Injectable Gel for Cheek Augmentation Using Cannula', 'orgStudyIdInfo': {'id': '1650-801-008'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'JUVÉDERM VOLUMA® XC Injectable Gel with Cannula', 'description': 'Participants had 1 cheek treated with JUVÉDERM VOLUMA® XC injectable gel with cannula.', 'interventionNames': ['Device: JUVÉDERM VOLUMA® XC injectable gel with cannula']}, {'type': 'OTHER', 'label': 'JUVÉDERM VOLUMA® XC Injectable Gel with Needle', 'description': 'Participants had 1 cheek treated with JUVÉDERM VOLUMA® XC injectable gel with a needle.', 'interventionNames': ['Device: JUVÉDERM VOLUMA® XC injectable gel with needle']}], 'interventions': [{'name': 'JUVÉDERM VOLUMA® XC injectable gel with cannula', 'type': 'DEVICE', 'description': 'Participants had 1 cheek treated with JUVÉDERM VOLUMA® XC injectable gel with cannula.', 'armGroupLabels': ['JUVÉDERM VOLUMA® XC Injectable Gel with Cannula']}, {'name': 'JUVÉDERM VOLUMA® XC injectable gel with needle', 'type': 'DEVICE', 'description': 'Participants had 1 cheek treated with JUVÉDERM VOLUMA® XC injectable gel with a needle.', 'armGroupLabels': ['JUVÉDERM VOLUMA® XC Injectable Gel with Needle']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90069', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Skin Care and Laser Physicians of Beverly Hills', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '92075', 'city': 'Solana Beach', 'state': 'California', 'country': 'United States', 'facility': 'Art of Skin MD', 'geoPoint': {'lat': 32.99115, 'lon': -117.27115}}, {'zip': '33137', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Baumann Cosmetic and Research Institute', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '63122', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Saint Louis University Dermatology', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '07601', 'city': 'Hackensack', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Skin Laser & Surgery Specialists of NY/NJ', 'geoPoint': {'lat': 40.88593, 'lon': -74.04347}}, {'zip': '10604', 'city': 'White Plains', 'state': 'New York', 'country': 'United States', 'facility': 'Rhoda S. Narins, MD, PC', 'geoPoint': {'lat': 41.03399, 'lon': -73.76291}}, {'zip': '27517', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Aesthetic Solutions, PA', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}], 'overallOfficials': [{'name': 'Steve Abrams', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Allergan'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Allergan', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}