Ignite Creation Date:
2025-12-25 @ 5:03 AM
Ignite Modification Date:
2025-12-26 @ 4:05 AM
Study NCT ID:
NCT03166618
Status:
TERMINATED
Last Update Posted:
2018-10-18
First Post:
2017-03-06
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Safety and Effectiveness of JUVÉDERM VOLUMA® XC Injectable Gel for Correction of Temple Hollowing
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'IR-CTRegistration@allergan.com', 'phone': '877-277-8566', 'title': 'Therapeutic Area Head', 'organization': 'Allergan Sales LLC'}, 'certainAgreement': {'otherDetails': 'The TI is responsible for compliance with the protocol at the investigational site. A representative of Allergan will make frequent contact with the TI and his/her research staff and will conduct regular monitoring visits at the site to review subject and device accountability records for compliance with the protocol', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Due to low patient enrollment, the target number of participants needed to achieve target power and statistically reliable results was not met.'}}, 'adverseEventsModule': {'timeFrame': '3 months', 'description': 'Up to 189 subjects were planned; 1 subject was enrolled in the control\\_No Treatment arm', 'eventGroups': [{'id': 'EG000', 'title': 'VOLUMA® XC Treatment', 'description': 'Participants will be treated with JUVÉDERM® VOLUMA® XC injectable gel in both temples (area above the eye). Participants are eligible for touch-up treatment 30 days later.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control_No Treatment', 'description': 'No treatment is administered.', 'otherNumAtRisk': 1, 'deathsNumAtRisk': 1, 'otherNumAffected': 0, 'seriousNumAtRisk': 1, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With at Least a 1-Point Improvement (Decrease) in Both Temples as Assessed by the Evaluating Investigator Using the Allergan Temple Hollowing Scale (ATHS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'VOLUMA® XC Treatment', 'description': 'Participants will be treated with JUVÉDERM® VOLUMA® XC injectable gel in both temples (area above the eye). Participants are eligible for touch-up treatment 30 days later.'}, {'id': 'OG001', 'title': 'Control_No Treatment', 'description': 'No treatment is administered.'}], 'timeFrame': 'Change from Baseline to Month 3', 'description': "The Evaluating Investigator will assess the participant's temple hollowing using the ATHS 5-point scale where: 0=convex, rounded temple to 4=severe, deeply recessed, sunken appearance. A 1-point decrease from Baseline indicates improvement.", 'reportingStatus': 'POSTED', 'populationDescription': 'Up to 189 subjects were planned; 1 subject was enrolled in the control\\_No Treatment arm. Terminated study; no treatment was administered and no analyses were conducted.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants "Improved" or "Much Improved" as Assessed by the Evaluating Investigator Using the Global Aesthetic Improvement Scale (GAIS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'VOLUMA® XC Treatment', 'description': 'Participants will be treated with JUVÉDERM® VOLUMA® XC injectable gel in both temples (area above the eye). Participants are eligible for touch-up treatment 30 days later.'}, {'id': 'OG001', 'title': 'Control_No Treatment', 'description': 'No treatment is administered.'}], 'timeFrame': 'Month 3', 'description': "The Evaluating Investigator will assess the participant's temple area using the GAIS 5-point scale where: 2=much improved, 1=improved, 0=no change, -1=worse and -2=much worse. The percentage of participants who the Evaluating Investigator assesses as 2=much improved or 1=improved will be reported.", 'reportingStatus': 'POSTED', 'populationDescription': 'Up to 189 subjects were planned; 1 subject was enrolled in the control\\_No Treatment arm. Terminated study; no treatment was administered and no analyses were conducted.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants "Improved" or "Much Improved" as Assessed by the Participant Using the GAIS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'VOLUMA® XC Treatment', 'description': 'Participants will be treated with JUVÉDERM® VOLUMA® XC injectable gel in both temples (area above the eye). Participants are eligible for touch-up treatment 30 days later.'}, {'id': 'OG001', 'title': 'Control_No Treatment', 'description': 'No treatment is administered.'}], 'timeFrame': 'Month 3', 'description': 'The participant will assess their temple area using the GAIS 5-point scale where: 2=much improved, 1=improved, 0=no change, -1=worse and -2=much worse. The percentage of participants who assess themselves as 2=much improved or 1=improved will be reported.', 'reportingStatus': 'POSTED', 'populationDescription': 'Up to 189 subjects were planned; 1 subject was enrolled in the control\\_No Treatment arm. Terminated study; no treatment was administered and no analyses were conducted.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'VOLUMA® XC Treatment', 'description': 'Participants will be treated with JUVÉDERM® VOLUMA® XC injectable gel in both temples (area above the eye). Participants are eligible for touch-up treatment 30 days later.'}, {'id': 'FG001', 'title': 'Control_No Treatment', 'description': 'No treatment is administered.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Study was Terminated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': 'Up to 189 subjects were planned; 1 subject was enrolled but did not receive treatment.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'VOLUMA® XC Treatment', 'description': 'Participants will be treated with JUVÉDERM® VOLUMA® XC injectable gel in both temples (area above the eye). Participants are eligible for touch-up treatment 30 days later.'}, {'id': 'BG001', 'title': 'Control_No Treatment', 'description': 'No treatment is administered.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years'}, {'title': 'Between 18 and 65 years'}, {'title': '>=65 years'}]}], 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female'}, {'title': 'Male'}]}], 'unitOfMeasure': 'participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino'}, {'title': 'Not Hispanic or Latino'}, {'title': 'Unknown or Not Reported'}]}], 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native'}, {'title': 'Asian'}, {'title': 'Native Hawaiian or Other Pacific Islander'}, {'title': 'Black or African American'}, {'title': 'White'}, {'title': 'More than one race'}, {'title': 'Unknown or Not Reported'}]}], 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Up to 189 subjects were planned; 1 subject was enrolled in the control\\_No Treatment arm. Due to confidentiality considerations, baseline data is not being provided to protect participant privacy.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-02-24', 'size': 983058, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2018-07-17T11:09', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1}}, 'statusModule': {'whyStopped': 'Business decision to stop the program.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2017-04-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2017-07-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-16', 'studyFirstSubmitDate': '2017-03-06', 'resultsFirstSubmitDate': '2018-07-20', 'studyFirstSubmitQcDate': '2017-05-23', 'lastUpdatePostDateStruct': {'date': '2018-10-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-10-16', 'studyFirstPostDateStruct': {'date': '2017-05-25', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2018-10-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-07-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With at Least a 1-Point Improvement (Decrease) in Both Temples as Assessed by the Evaluating Investigator Using the Allergan Temple Hollowing Scale (ATHS)', 'timeFrame': 'Change from Baseline to Month 3', 'description': "The Evaluating Investigator will assess the participant's temple hollowing using the ATHS 5-point scale where: 0=convex, rounded temple to 4=severe, deeply recessed, sunken appearance. A 1-point decrease from Baseline indicates improvement."}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants "Improved" or "Much Improved" as Assessed by the Evaluating Investigator Using the Global Aesthetic Improvement Scale (GAIS)', 'timeFrame': 'Month 3', 'description': "The Evaluating Investigator will assess the participant's temple area using the GAIS 5-point scale where: 2=much improved, 1=improved, 0=no change, -1=worse and -2=much worse. The percentage of participants who the Evaluating Investigator assesses as 2=much improved or 1=improved will be reported."}, {'measure': 'Percentage of Participants "Improved" or "Much Improved" as Assessed by the Participant Using the GAIS', 'timeFrame': 'Month 3', 'description': 'The participant will assess their temple area using the GAIS 5-point scale where: 2=much improved, 1=improved, 0=no change, -1=worse and -2=much worse. The percentage of participants who assess themselves as 2=much improved or 1=improved will be reported.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Temple Hollowing']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://allerganclinicaltrials.com', 'label': 'More Information'}]}, 'descriptionModule': {'briefSummary': 'This study will evaluate the safety and effectiveness of JUVÉDERM VOLUMA XC injectable gel in adult participants seeking correction of temple hollowing.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '22 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n-Has temple hollowing and is seeking restoration in the temple area.\n\nExclusion Criteria:\n\n* Has temple hollowing due to due to trauma, congenital malformations, or lipodystrophy\n* Has received permanent facial implants in the face or neck\n* Has undergone fat injections\n* Has tattoos, piercings, facial hair or scars that would interfere with visual assessment of the temple\n* Has undergone semipermanent dermal filler treatment in the temple or mid-face within the past 36 months\n* Has undergone dermal filler injections above the subnasale within the past 24 months\n* Has temporal arteritis or history of temporal arteritis\n* Has temporomandibular joint dysfunction\n* Has eye inflammation or infection\n* Has a history of detached retina, retinal vascular occlusion, narrow angle glaucoma, or neovascular eye disease\n* Has ever received a facelift, browlift, or facial reconstructive surgery\n* Has undergone mesotherapy or cosmetic treatment (laser, photomodulation, intense pulsed light, radio frequency, dermabrasion, moderate or greater depth chemical peel, liposuction, lipolysis, or other ablative procedures) anywhere in the face or neck or botulinum toxin injections within the past 6 months\n* Has experienced trauma to the temple within the past 6 months or has residual deficiencies, deformities, or scarring\n* Has a tendency to develop hypertrophic scarring\n* Has a history of anaphylaxis or allergy to lidocaine (or any amide-based anesthetics), hyaluronic acid products, or Streptococcal protein\n* Has porphyria or untreated epilepsy\n* Has active autoimmune disease\n* Has current cutaneous or mucosal inflammatory or infectious processes\n* Is on a lidocaine, anticoagulation therapy'}, 'identificationModule': {'nctId': 'NCT03166618', 'briefTitle': 'Safety and Effectiveness of JUVÉDERM VOLUMA® XC Injectable Gel for Correction of Temple Hollowing', 'organization': {'class': 'INDUSTRY', 'fullName': 'Allergan'}, 'officialTitle': 'A Multicenter, Single-Blind, Randomized, Parallel-Group, Controlled Study of the Safety and Effectiveness of JUVÉDERM VOLUMA® XC Injectable Gel for Correction of Temple Hollowing', 'orgStudyIdInfo': {'id': 'VOLUMA-007'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'VOLUMA® XC Treatment', 'description': 'Participants will be treated with JUVÉDERM® VOLUMA® XC injectable gel in both temples (area above the eye). Participants are eligible for touch-up treatment 30 days later.', 'interventionNames': ['Device: Juvéderm® VOLUMA XC']}, {'type': 'NO_INTERVENTION', 'label': 'Control_No Treatment', 'description': 'No treatment is administered.'}], 'interventions': [{'name': 'Juvéderm® VOLUMA XC', 'type': 'DEVICE', 'description': 'Juvéderm® VOLUMA XC hyaluronic acid injectable gel', 'armGroupLabels': ['VOLUMA® XC Treatment']}]}, '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}}], 'overallOfficials': [{'name': 'Nikki Amaratunge', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Allergan'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Allergan', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}