Ignite Creation Date:
2025-12-24 @ 4:57 PM
Ignite Modification Date:
2025-12-29 @ 10:48 PM
Study NCT ID:
NCT03869450
Status:
COMPLETED
Last Update Posted:
2022-08-26
First Post:
2018-11-14
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Evaluate Effectiveness and Safety of Hyaluronic Acid (HA) Fillers
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'reception.seupp@galderma.com', 'phone': '+4618 474 9000', 'title': 'Clinical Project Manager', 'organization': 'Q-Med AB'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '24-27 weeks (depending on how long screening period), from signature of informed consent to last study visit.', 'eventGroups': [{'id': 'EG000', 'title': 'Restylane Volyme', 'description': 'According to the treatment algorithm, Restylane Volyme was chosen for participants whose primary need for treatment was volume deficiency.\n\nRestylane Volyme: Hyaluronic based filler', 'otherNumAtRisk': 31, 'deathsNumAtRisk': 31, 'otherNumAffected': 3, 'seriousNumAtRisk': 31, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Restylane Defyne', 'description': 'According to the treatment algorithm, Restylane Defyne was chosen for participants with thin tissue coverage and whose primary need for treatment was lifting or contouring.\n\nRestylane Defyne: Hyaluronic based filler', 'otherNumAtRisk': 25, 'deathsNumAtRisk': 25, 'otherNumAffected': 0, 'seriousNumAtRisk': 25, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Restylane Lyft Lidocaine', 'description': 'According to the treatment algorithm, Restylane Lyft Lidocaine was chosen for participants with thick tissue coverage and whose primary need for treatment was lifting or contouring.\n\nRestylane Lyft Lidocaine: Hyaluronic based filler', 'otherNumAtRisk': 34, 'deathsNumAtRisk': 34, 'otherNumAffected': 0, 'seriousNumAtRisk': 34, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Influenza', 'notes': 'Not related to study product or injection procedure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With Aesthetic Improvement of Midface', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Restylane Volyme', 'description': 'According to the treatment algorithm, Restylane Volyme was chosen for participants whose primary need for treatment was volume deficiency.\n\nRestylane Volyme: Hyaluronic based filler'}, {'id': 'OG001', 'title': 'Restylane Defyne', 'description': 'According to the treatment algorithm, Restylane Defyne was chosen for participants with thin tissue coverage and whose primary need for treatment was lifting or contouring.\n\nRestylane Defyne: Hyaluronic based filler'}, {'id': 'OG002', 'title': 'Restylane Lyft Lidocaine', 'description': 'According to the treatment algorithm, Restylane Lyft Lidocaine was chosen for participants with thick tissue coverage and whose primary need for treatment was lifting or contouring.\n\nRestylane Lyft Lidocaine: Hyaluronic based filler'}], 'classes': [{'categories': [{'measurements': [{'value': '96.8', 'groupId': 'OG000', 'lowerLimit': '83.3', 'upperLimit': '99.9'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '85.8', 'upperLimit': '100.0'}, {'value': '97.1', 'groupId': 'OG002', 'lowerLimit': '84.7', 'upperLimit': '99.9'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '8 weeks', 'description': 'A blinded evaluator assesses the improvement compared to baseline (pre-treatment) using a 5-graded scale; Worse, No change, Improved, Much improved or Very much improved. Aesthetic improvement of midface is defined as those participants assessed as Improved, Much improved or Very much improved.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Improved Midface Volume', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Restylane Volyme', 'description': 'According to the treatment algorithm, Restylane Volyme was chosen for participants whose primary need for treatment was volume deficiency.\n\nRestylane Volyme: Hyaluronic based filler'}, {'id': 'OG001', 'title': 'Restylane Defyne', 'description': 'According to the treatment algorithm, Restylane Defyne was chosen for participants with thin tissue coverage and whose primary need for treatment was lifting or contouring.\n\nRestylane Defyne: Hyaluronic based filler'}, {'id': 'OG002', 'title': 'Restylane Lyft Lidocaine', 'description': 'According to the treatment algorithm, Restylane Lyft Lidocaine was chosen for participants with thick tissue coverage and whose primary need for treatment was lifting or contouring.\n\nRestylane Lyft Lidocaine: Hyaluronic based filler'}], 'classes': [{'categories': [{'measurements': [{'value': '90.3', 'groupId': 'OG000', 'lowerLimit': '74.2', 'upperLimit': '98.0'}, {'value': '87.5', 'groupId': 'OG001', 'lowerLimit': '67.6', 'upperLimit': '97.3'}, {'value': '79.4', 'groupId': 'OG002', 'lowerLimit': '62.1', 'upperLimit': '91.3'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '8 weeks', 'description': 'A blinded evaluator assessed the fullness of the midface by using a 4-graded scale where 1= fairly full and 4= substantial loss of fullness.\n\nImproved midface volume was defined as at least a 1-grade decrease from baseline.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Assessed as Having Natural Treatment Results', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Restylane Volyme', 'description': 'According to the treatment algorithm, Restylane Volyme was chosen for participants whose primary need for treatment was volume deficiency.\n\nRestylane Volyme: Hyaluronic based filler'}, {'id': 'OG001', 'title': 'Restylane Defyne', 'description': 'According to the treatment algorithm, Restylane Defyne was chosen for participants with thin tissue coverage and whose primary need for treatment was lifting or contouring.\n\nRestylane Defyne: Hyaluronic based filler'}, {'id': 'OG002', 'title': 'Restylane Lyft Lidocaine', 'description': 'According to the treatment algorithm, Restylane Lyft Lidocaine was chosen for participants with thick tissue coverage and whose primary need for treatment was lifting or contouring.\n\nRestylane Lyft Lidocaine: Hyaluronic based filler'}], 'classes': [{'categories': [{'measurements': [{'value': '93.5', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}, {'value': '93.9', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '8 weeks', 'description': 'Blinded evaluator assessed participants by answering Strongly agree/Agree/Neither agree nor disagree/Disagree/Strongly disagree to the question "Are the subject\'s treatment results natural looking?". Having natural treatment results is defined as being assessed with answers Strongly agree or Agree.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Restylane Volyme', 'description': 'According to the treatment algorithm, treated with Restylane Volyme\n\nRestylane Volyme: Hyaluronic based filler'}, {'id': 'FG001', 'title': 'Restylane Defyne', 'description': 'According to the treatment algorithm, treated with Restylane Defyne\n\nRestylane Defyne: Hyaluronic based filler'}, {'id': 'FG002', 'title': 'Restylane Lyft Lidocaine', 'description': 'According to the treatment algorithm, treated with Restylane Lyft Lidocaine\n\nRestylane Lyft Lidocaine: Hyaluronic based filler'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '31'}, {'groupId': 'FG001', 'numSubjects': '25'}, {'groupId': 'FG002', 'numSubjects': '34'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '23'}, {'groupId': 'FG002', 'numSubjects': '34'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}, {'value': '90', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Restylane Volyme', 'description': 'According to the treatment algorithm, Restylane Volyme was chosen for participants whose primary need for treatment was volume deficiency.\n\nRestylane Volyme: Hyaluronic based filler'}, {'id': 'BG001', 'title': 'Restylane Defyne', 'description': 'According to the treatment algorithm, Restylane Defyne was chosen for participants with thin tissue coverage and whose primary need for treatment was lifting or contouring.\n\nRestylane Defyne: Hyaluronic based filler'}, {'id': 'BG002', 'title': 'Restylane Lyft Lidocaine', 'description': 'According to the treatment algorithm, Restylane Lyft Lidocaine was chosen for participants with thick tissue coverage and whose primary need for treatment was lifting or contouring.\n\nRestylane Lyft Lidocaine: Hyaluronic based filler'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}, {'value': '90', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}, {'value': '74', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '16', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}, {'value': '89', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Italy', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '30', 'groupId': 'BG003'}]}]}, {'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '30', 'groupId': 'BG003'}]}]}, {'title': 'Germany', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '30', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-06-20', 'size': 674142, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-03-10T07:59', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-11-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2019-08-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-24', 'studyFirstSubmitDate': '2018-11-14', 'resultsFirstSubmitDate': '2020-03-17', 'studyFirstSubmitQcDate': '2019-03-08', 'lastUpdatePostDateStruct': {'date': '2022-08-26', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-04-01', 'studyFirstPostDateStruct': {'date': '2019-03-11', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-04-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-08-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Aesthetic Improvement of Midface', 'timeFrame': '8 weeks', 'description': 'A blinded evaluator assesses the improvement compared to baseline (pre-treatment) using a 5-graded scale; Worse, No change, Improved, Much improved or Very much improved. Aesthetic improvement of midface is defined as those participants assessed as Improved, Much improved or Very much improved.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With Improved Midface Volume', 'timeFrame': '8 weeks', 'description': 'A blinded evaluator assessed the fullness of the midface by using a 4-graded scale where 1= fairly full and 4= substantial loss of fullness.\n\nImproved midface volume was defined as at least a 1-grade decrease from baseline.'}, {'measure': 'Percentage of Participants Assessed as Having Natural Treatment Results', 'timeFrame': '8 weeks', 'description': 'Blinded evaluator assessed participants by answering Strongly agree/Agree/Neither agree nor disagree/Disagree/Strongly disagree to the question "Are the subject\'s treatment results natural looking?". Having natural treatment results is defined as being assessed with answers Strongly agree or Agree.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Volume Deficiency of the Midface']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to investigate the degree of improvement in appearance after treatment with different hyaluronic acid (HA) fillers. Product selection is based on Investigator assessment of participant tissue coverage and main treatment goal (volumizing, lifting or contouring).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '25 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male/Female 25 to 55 years old that needs lifting, contouring or volumization of the midface\n* Signed and dated informed consent\n\nExclusion Criteria:\n\n* Known/previous allergy or hypersensitivity to any injectable hyaluronic acid (HA) gel and lidocain\n* Previous use of any permanent or semi-permanent facial tissue augmentation therapy or contouring with, lifting threads, permanent implants, or autologous fat in the treatment area\n* Previous use of any HA or collagen based facial tissue augmentation therapy in the facial area, any previous use of neurotoxin or any previous facial surgery\n* Any medical condition that in the opinion of the Investigator would make the participant unsuitable for inclusion'}, 'identificationModule': {'nctId': 'NCT03869450', 'acronym': '05DF1707', 'briefTitle': 'A Study to Evaluate Effectiveness and Safety of Hyaluronic Acid (HA) Fillers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Galderma R&D'}, 'officialTitle': 'A Multi-center, Evaluator-blinded Study to Evaluate Effectiveness and Safety of HA Fillers for Lifting, Contouring and Correcting Volume Deficiency of the Midface Using an Individualized Treatment Algorithm', 'orgStudyIdInfo': {'id': '05DF1707'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Restylane Volyme', 'description': 'According to the treatment algorithm, treated with Restylane Volyme', 'interventionNames': ['Device: Restylane Volyme']}, {'type': 'EXPERIMENTAL', 'label': 'Restylane Defyne', 'description': 'According to the treatment algorithm, treated with Restylane Defyne', 'interventionNames': ['Device: Restylane Defyne']}, {'type': 'EXPERIMENTAL', 'label': 'Restylane Lyft Lidocaine', 'description': 'According to the treatment algorithm, treated with Restylane Lyft Lidocaine', 'interventionNames': ['Device: Restylane Lyft Lidocaine']}], 'interventions': [{'name': 'Restylane Volyme', 'type': 'DEVICE', 'description': 'Hyaluronic based filler', 'armGroupLabels': ['Restylane Volyme']}, {'name': 'Restylane Defyne', 'type': 'DEVICE', 'description': 'Hyaluronic based filler', 'armGroupLabels': ['Restylane Defyne']}, {'name': 'Restylane Lyft Lidocaine', 'type': 'DEVICE', 'description': 'Hyaluronic based filler', 'armGroupLabels': ['Restylane Lyft Lidocaine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80636', 'city': 'Munich', 'country': 'Germany', 'facility': 'Galderma Research Site', 'geoPoint': {'lat': 48.13743, 'lon': 11.57549}}, {'zip': '90141', 'city': 'Palermo', 'country': 'Italy', 'facility': 'Galderma Research Site', 'geoPoint': {'lat': 38.1166, 'lon': 13.3636}}, {'zip': 'EH10 4BE', 'city': 'Edinburgh', 'country': 'United Kingdom', 'facility': 'Galderma Research Site', 'geoPoint': {'lat': 55.95206, 'lon': -3.19648}}], 'overallOfficials': [{'name': 'Q-Med AB', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Galderma R&D'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Galderma R&D', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}