Ignite Creation Date:
2025-12-24 @ 2:12 PM
Ignite Modification Date:
2025-12-29 @ 6:52 AM
Study NCT ID:
NCT07186595
Status:
RECRUITING
Last Update Posted:
2025-12-22
First Post:
2025-09-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Safety and Effectiveness of JUVÉDERM Products in Adult Participants for the Change of Their Overall Facial Appearance
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 94}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-09-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-18', 'studyFirstSubmitDate': '2025-09-16', 'studyFirstSubmitQcDate': '2025-09-16', 'lastUpdatePostDateStruct': {'date': '2025-12-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Change from Baseline in the Participant's Rasch-Transformed Score of the FACE-Q™ Satisfaction with Facial Appearance Scale", 'timeFrame': 'Month 3', 'description': 'The FACE-Q Satisfaction with Facial Appearance is a validated questionnaire that asks participants to report their level of satisfaction with the appearance of their face.'}, {'measure': 'Number of Participants with Adverse Events (AEs)', 'timeFrame': 'Up to approximately Month 6', 'description': 'An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants Achieving "Responder" Status of Global Aesthetic Improvement on Facial Appearance Based on the Principal Investigator\'s Assessment Using the Global Aesthetic Improvement Scale (GAIS)', 'timeFrame': 'Month 3', 'description': 'The GAIS uses a 5-point scale where: 2=much improved, 1=improved, 0=no change, -1=worse and -2=much worse. A responder is defined as "improved" or "much improved" in the overall aesthetics assessment in the periorbital area.'}, {'measure': "Change from Baseline in the Participant's Rasch-Transformed Score of the FACE-Q Psychological Function Scale", 'timeFrame': 'Month 3', 'description': 'The FACE-Q Psychological Function is a validated questionnaire that asks participants to report their level of satisfaction with psychological function.'}, {'measure': "Change from Baseline in the Participant's Rasch-Transformed Score of the FACE-Q Social Function Scale", 'timeFrame': 'Month 3', 'description': 'The FACE-Q Social Function Scale is a validated questionnaire that asks participants to report their level of satisfaction with social function.'}, {'measure': "Change from Baseline in the Participant's Rasch-Transformed Score of the SKIN-Q Feels Scale", 'timeFrame': 'Month 3', 'description': 'The SKIN-Q Scale is a validated questionnaire that asks participants to report their level of satisfaction with skin quality related to how the skin feels.'}, {'measure': "Change from Baseline in the Participant's Rasch-Transformed Score of the SKIN-Q Looks Scale", 'timeFrame': 'Month 3', 'description': 'The SKIN-Q Scale is a validated questionnaire that asks participants to report their level of satisfaction with skin quality related to how the skin looks.'}, {'measure': 'Percentage of Participants Achieving "Responder" Status Based on Participant Responses on the Natural Look Satisfaction Scale (NLSS) Assessment', 'timeFrame': 'Month 3', 'description': 'The NLSS is an 8-item scale that measures satisfaction with various attributes that are associated with natural looking results following aesthetic treatment.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Mid Face Volume Deficit', 'JUVÉDERM VOLUX XC', 'JUVÉDERM VOLUMA XC', 'JUVÉDERM VOLLURE XC', 'JUVÉDERM VOLBELLA XC', 'SKINVIVE by JUVÉDERM', 'JUVÉDERM ULTRA XC', 'JUVÉDERM ULTRA PLUS XC'], 'conditions': ['Mid Face Volume Deficit']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.abbvieclinicaltrials.com/study/?id=M25-631', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety and effectiveness of JUVÉDERM products in adults seeking improvement in facial volume and/or skin quality.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '22 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Must meet at least 3 of the following criteria for treatment in the face with at least 2 JUVÉDERM products, per investigator's assessment:\n\n * Minimal, moderate, or severe on Allergan Temple Hollowing Scale (ATHS)\n * Moderate or severe for both eyes on Allergan Infraorbital Hollow Scale (AIHS)\n * Moderate or severe on Allergan Cheek Smoothness Scale (ACSS)\n * Moderate, significant, or severe on Mid-face Volume Deficit Scale (MFVDS)\n * Moderate or severe on Nasolabial Fold Severity Scale (NLFSS)\n * Minimal, mild, or moderate on Allergan Lip Fullness Scale 2 (ALFS2)\n * Moderate or severe on Allergan Chin Retrusion Scale (ACRS)\n * Moderate or severe on Allergan Loss of Jawline Definition Scale (ALJDS)\n* Must be in good health as determined by subject's medical history, physical examination, and vital sign measurements.\n\nExclusion Criteria:\n\n* Prior treatment with non-permanent soft tissue fillers or fat-reducing injectables in the face or neck within 12 months prior to screening.\n* Excessively loose skin in the face and/or neck.\n* Tendency to develop hypertrophic scarring and/or keloid scarring."}, 'identificationModule': {'nctId': 'NCT07186595', 'briefTitle': 'A Study to Evaluate the Safety and Effectiveness of JUVÉDERM Products in Adult Participants for the Change of Their Overall Facial Appearance', 'organization': {'class': 'INDUSTRY', 'fullName': 'AbbVie'}, 'officialTitle': 'A Prospective, Open-Label Study to Evaluate Subject Satisfaction With Overall Facial Appearance After Treatment With JUVÉDERM® Products in Medical Weight Loss (MWL) Subjects', 'orgStudyIdInfo': {'id': 'M25-631'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Open-Label JUVÉDERM', 'description': 'Participants will receive at least 2 JUVÉDERM products for at least 3 indications (specific products and indications will be at the discretion of the investigator and per participant eligibility criteria) at Treatment Visit 1.', 'interventionNames': ['Device: JUVÉDERM VOLUX XC', 'Device: JUVÉDERM VOLUMA XC', 'Device: JUVÉDERM VOLBELLA XC', 'Device: JUVÉDERM VOLLURE XC', 'Device: SKINVIVE by JUVÉDERM', 'Device: JUVÉDERM ULTRA XC', 'Device: JUVÉDERM ULTRA PLUS XC']}], 'interventions': [{'name': 'JUVÉDERM VOLUX XC', 'type': 'DEVICE', 'description': 'Injections', 'armGroupLabels': ['Open-Label JUVÉDERM']}, {'name': 'JUVÉDERM VOLUMA XC', 'type': 'DEVICE', 'description': 'Injections', 'armGroupLabels': ['Open-Label JUVÉDERM']}, {'name': 'JUVÉDERM VOLBELLA XC', 'type': 'DEVICE', 'description': 'Injections', 'armGroupLabels': ['Open-Label JUVÉDERM']}, {'name': 'JUVÉDERM VOLLURE XC', 'type': 'DEVICE', 'description': 'Injections', 'armGroupLabels': ['Open-Label JUVÉDERM']}, {'name': 'SKINVIVE by JUVÉDERM', 'type': 'DEVICE', 'description': 'Injections', 'armGroupLabels': ['Open-Label JUVÉDERM']}, {'name': 'JUVÉDERM ULTRA XC', 'type': 'DEVICE', 'description': 'Injections', 'armGroupLabels': ['Open-Label JUVÉDERM']}, {'name': 'JUVÉDERM ULTRA PLUS XC', 'type': 'DEVICE', 'description': 'Injections', 'armGroupLabels': ['Open-Label JUVÉDERM']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90025', 'city': 'Los Angeles', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Kian Aesthetic Institute /ID# 277045', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '92121', 'city': 'San Diego', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'West Dermatology La Jolla /ID# 277034', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '92083', 'city': 'Vista', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Pacific Clinical Innovations /ID# 277026', 'geoPoint': {'lat': 33.20004, 'lon': -117.24254}}, {'zip': '33146-1837', 'city': 'Coral Gables', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Skin Research Institute LLC /ID# 277038', 'geoPoint': {'lat': 25.72149, 'lon': -80.26838}}, {'zip': '30328', 'city': 'Atlanta', 'state': 'Georgia', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Monarch Plastic Surgery and Skin Renewal Center /ID# 278182', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '60069', 'city': 'Lincolnshire', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Advanced Dermatology - Lincolnshire /ID# 277036', 'geoPoint': {'lat': 42.19002, 'lon': -87.9084}}, {'zip': '70001', 'city': 'Metairie', 'state': 'Louisiana', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'H&H Research, LLC /ID# 277084', 'geoPoint': {'lat': 29.98409, 'lon': -90.15285}}, {'zip': '70115', 'city': 'New Orleans', 'state': 'Louisiana', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'DelRicht Research - New Orleans 308 /ID# 277039', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'zip': '77401', 'city': 'Bellaire', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Bellaire Dermatology Associates /ID# 278180', 'geoPoint': {'lat': 29.70579, 'lon': -95.45883}}, {'zip': '22209', 'city': 'Arlington', 'state': 'Virginia', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'SkinDC /ID# 277062', 'geoPoint': {'lat': 38.88101, 'lon': -77.10428}}], 'centralContacts': [{'name': 'ABBVIE CALL CENTER', 'role': 'CONTACT', 'email': 'abbvieclinicaltrials@abbvie.com', 'phone': '844-663-3742'}], 'overallOfficials': [{'name': 'ABBVIE INC.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AbbVie'}]}, 'ipdSharingStatementModule': {'url': 'https://vivli.org/ourmember/abbvie/', 'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/', 'ipdSharing': 'YES', 'description': 'AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.', 'accessCriteria': 'To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AbbVie', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}