Ignite Creation Date:
2025-12-24 @ 6:51 PM
Ignite Modification Date:
2025-12-28 @ 9:10 AM
Study NCT ID:
NCT01545557
Status:
COMPLETED
Last Update Posted:
2023-03-01
First Post:
2012-02-24
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Pan Facial Volume Restoration
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001284', 'term': 'Atrophy'}], 'ancestors': [{'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'aestheticclinicaltrials@galderma.com', 'phone': '817-961-5655', 'title': 'Clinical project manager', 'organization': 'Galderma'}, 'certainAgreement': {'otherDetails': "Any intent of Institution and Investigator/Researcher to publish or disclose in any way Information requires Sponsor's prior written approval. Investigator/Researcher shall provide his draft of such publication to Sponsor for review and approval at least two months prior to the date of intended publication. Sponsor hereby agrees he shall endeavour to preserve accuracy of results in authorized publications and negative as well as positive results shall be published or made publicly available.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From Baseline up to 18 Months after last injection', 'eventGroups': [{'id': 'EG000', 'title': 'Hyaluronic Acid', 'description': 'Hyaluronic acid dermal filler gel: 1 injection per indication and 1 touch-up injection if necessary', 'otherNumAtRisk': 60, 'deathsNumAtRisk': 60, 'otherNumAffected': 2, 'seriousNumAtRisk': 60, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Back pain', 'notes': 'unrelated to study product or injection procedure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean Change From Baseline in Volume Loss Assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Volume loss18 Months After Injection', 'description': 'Full face volume loss 18 months after last injections for all subjects having received Hyaluronic Acid injections'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.8', 'spread': '0.7', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 18 Months after last injection', 'description': 'Overall loss of volume on full face was graded on a volume loss scale (VLS) of 0 to 3 by the investigator as follow: 0= normal, 1= evidence of early soft tissue ptosis or atrophy slightly visible, 2=visible depression or descent, 3= severe depression or atrophy. Last injections were given either at baseline or touch-up injections (if needed) on previously injected areas at 3 Weeks after baseline.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all participants who were injected.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Satisfied or Very Satisfied at 3 Weeks After Last Injection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Full Face Overall Aesthetic Outcome', 'description': 'All participants satisfied to very satisfied with overall full face aesthetic outcome'}], 'classes': [{'title': 'Satisfied', 'categories': [{'measurements': [{'value': '32.2', 'groupId': 'OG000'}]}]}, {'title': 'Very satisfied', 'categories': [{'measurements': [{'value': '67.8', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At 3 Weeks after last injection', 'description': 'Participants satisfaction with the overall, full face aesthetic results were assessed by use of participants global satisfaction questionnaire. Participants rated their satisfaction by answering question ; Rate overall, full face aesthetic outcome using the following options: not satisfied, somewhat satisfied, satisfied or very satisfied. Percentage of participants satisfied and very satisfied with the full face aesthetic outcome at 3 weeks after last injection were reported.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': "ITT population included all participants who were injected. Here, 'overall number of participants analyzed' signifies participants who completed a questionnaire about their satisfaction with the overall, full face aesthetic outcome."}, {'type': 'SECONDARY', 'title': 'Percentage of Investigators Satisfied With the Use of Study Hyaluronic Acid Dermal Filler', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'The Study Investigators (Injectors)', 'description': 'The study investigators (injectors) who injected study product to the participants included in the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to 18 Months after last injection', 'description': 'The study investigators (injectors) were requested to complete a questionnaire about their satisfaction with the use of study hyaluronic acid dermal filler (Emervel® Volume Lidocaine). The percentage of investigators who agreed to use Emervel® Volume Lidocaine again were reported in this outcome measure.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Here overall number of participants analyzed refers to the study investigators who completed a questionnaire about their satisfaction with the use of study hyaluronic acid dermal filler.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Hyaluronic Acid', 'description': 'All injected participants.'}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline up to 18 Months after last injection', 'description': 'An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population was defined as all participants who were injected with the study product.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Satisfied or Very Satisfied at 18 Months After Last Injection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Full Face Overall Aesthetic Outcome', 'description': 'Percent of subjects satisfied to very satisfied with overall full face aesthetic outcome'}], 'classes': [{'title': 'Satisfied', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}]}]}, {'title': 'Very satisfied', 'categories': [{'measurements': [{'value': '70', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At 18 Months after last injection', 'description': 'Participants satisfaction with the overall, full face aesthetic results were assessed by use of participants global satisfaction questionnaire. Participants rated their satisfaction by answering question; rate overall, full face aesthetic outcome using the following options : not satisfied, somewhat satisfied, satisfied or very satisfied. Percentage of participants satisfied and very satisfied with the full-face aesthetic outcome at 18 Months after last injection were reported.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All injected subjects satisfied to very satisfied'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Hyaluronic Acid', 'description': 'Hyaluronic acid dermal filler gel: 1 injection per indication and 1 touch-up injection if necessary'}], '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': 'Sixty subjects were recruited across 4 sites in Brazil (15 subjects per site) between February 2012 and October 2013.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Hyaluronic Acid', 'description': 'Hyaluronic acid dermal filler gel: 1 injection per indication and 1 touch-up injection if necessary'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '53.5', 'spread': '8.3', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '54', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Race', 'categories': [{'title': 'Black or African American', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '53', 'groupId': 'BG000'}]}, {'title': 'Hispanic', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Brazil', 'categories': [{'measurements': [{'value': '60', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-02-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2014-03-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-27', 'studyFirstSubmitDate': '2012-02-24', 'resultsFirstSubmitDate': '2021-02-16', 'studyFirstSubmitQcDate': '2012-03-01', 'lastUpdatePostDateStruct': {'date': '2023-03-01', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-02-27', 'studyFirstPostDateStruct': {'date': '2012-03-06', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2023-03-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-03-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Change From Baseline in Volume Loss Assessment', 'timeFrame': 'Baseline and 18 Months after last injection', 'description': 'Overall loss of volume on full face was graded on a volume loss scale (VLS) of 0 to 3 by the investigator as follow: 0= normal, 1= evidence of early soft tissue ptosis or atrophy slightly visible, 2=visible depression or descent, 3= severe depression or atrophy. Last injections were given either at baseline or touch-up injections (if needed) on previously injected areas at 3 Weeks after baseline.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants Satisfied or Very Satisfied at 3 Weeks After Last Injection', 'timeFrame': 'At 3 Weeks after last injection', 'description': 'Participants satisfaction with the overall, full face aesthetic results were assessed by use of participants global satisfaction questionnaire. Participants rated their satisfaction by answering question ; Rate overall, full face aesthetic outcome using the following options: not satisfied, somewhat satisfied, satisfied or very satisfied. Percentage of participants satisfied and very satisfied with the full face aesthetic outcome at 3 weeks after last injection were reported.'}, {'measure': 'Percentage of Investigators Satisfied With the Use of Study Hyaluronic Acid Dermal Filler', 'timeFrame': 'Baseline up to 18 Months after last injection', 'description': 'The study investigators (injectors) were requested to complete a questionnaire about their satisfaction with the use of study hyaluronic acid dermal filler (Emervel® Volume Lidocaine). The percentage of investigators who agreed to use Emervel® Volume Lidocaine again were reported in this outcome measure.'}, {'measure': 'Number of Participants With Adverse Events (AEs)', 'timeFrame': 'Baseline up to 18 Months after last injection', 'description': 'An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.'}, {'measure': 'Percentage of Participants Satisfied or Very Satisfied at 18 Months After Last Injection', 'timeFrame': 'At 18 Months after last injection', 'description': 'Participants satisfaction with the overall, full face aesthetic results were assessed by use of participants global satisfaction questionnaire. Participants rated their satisfaction by answering question; rate overall, full face aesthetic outcome using the following options : not satisfied, somewhat satisfied, satisfied or very satisfied. Percentage of participants satisfied and very satisfied with the full-face aesthetic outcome at 18 Months after last injection were reported.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Volume loss'], 'conditions': ['Volume Loss (Soft Tissue Ptosis or Atrophy )']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to assess performance and tolerance as well as investigator and subject satisfaction further to pan-facial volume restoration with a new cross-linked hyaluronic acid dermal filler containing lidocaine 0.3%.', 'detailedDescription': 'Clinical hypothesis: The global approach of the subject pan-facial dermal volume depletion and face soft-tissue contour defects correction using specific dermal filler for all indications to be injected will satisfy both subjects and investigators.\n\nThis device will be used for full face correction of volume loss: chin, temporal areas, jawline, cheek, cheekbones, deep to very deep nasolabial folds (only if cheekbones are injected concomitantly).\n\nStudy duration will be up to 19 months. Injections will be performed at baseline. If necessary, investigator will perform touch-up injections at the following visit (3 weeks after baseline injection).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects seeking treatment for correction of volume loss.\n* Subjects presenting a score of at least 2 (visible depression or descent) for whole face on the volume loss scale and at least 2 indications affected by volume loss among the following: chin temporal areas, jawlines, cheeks, cheekbones, deep to very deep nasolabial folds (severity score 4 at least on Lemperle rating scale) if cheekbones are injected.\n\nExclusion Criteria:\n\n* Subjects at risk in term of precautions, warnings and contraindication referred in the package insert of the study device,\n* Subjects who underwent previous injection of permanent filler in the injected area.'}, 'identificationModule': {'nctId': 'NCT01545557', 'acronym': 'EVE', 'briefTitle': 'Pan Facial Volume Restoration', 'organization': {'class': 'INDUSTRY', 'fullName': 'Galderma R&D'}, 'officialTitle': 'Pan Facial Volume Restoration With a New Hyaluronic Acid Dermal Filler', 'orgStudyIdInfo': {'id': 'RD.03.CIP.29090'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Hyaluronic acid dermal filler', 'description': 'One Emervel Volume injection at baseline and touch up injections 3 weeks after if needed', 'interventionNames': ['Device: Hyaluronic acid dermal filler gel']}], 'interventions': [{'name': 'Hyaluronic acid dermal filler gel', 'type': 'DEVICE', 'otherNames': ['Study filler is Emervel Volume Lidocaine.'], 'description': '1 Emervel Volume injection per indication and 1 touch-up injection if necessary', 'armGroupLabels': ['Hyaluronic acid dermal filler']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Botucatu', 'country': 'Brazil', 'facility': 'Galderma Investigational Center', 'geoPoint': {'lat': -22.88583, 'lon': -48.445}}, {'city': 'Rio de Janeiro', 'country': 'Brazil', 'facility': 'Galderma Investigational Center', 'geoPoint': {'lat': -22.90642, 'lon': -43.18223}}, {'city': 'Saö Paulo', 'country': 'Brazil', 'facility': 'Galderma Investigational Center'}], 'overallOfficials': [{'name': 'Clinical Scientist', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Galderma R&D'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Galderma R&D', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}