Ignite Creation Date:
2025-12-24 @ 1:02 PM
Ignite Modification Date:
2025-12-25 @ 12:20 PM
Study NCT ID:
NCT00653861
Status:
COMPLETED
Last Update Posted:
2014-10-13
First Post:
2008-04-02
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Safety and Effectiveness of JUVÉDERM™ Injectable Gel With Lidocaine
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'devicetrials@allergan.com', 'phone': '(805) 961-5500', 'title': 'Therapeutic Area Head', 'organization': 'Allergan Medical'}, 'certainAgreement': {'otherDetails': 'At least ninety (90) days prior to any proposed submission for publication or presentation of Study data or other findings related to the Study, the Investigator will provide the Sponsor with a manuscript of such submission(s) for review and comment.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Juvéderm Lidocaine Nasolabial Folds (NLFs)', 'description': 'Nasolabial folds on one side of the face injected with the Juvederm formulation with lidocaine', 'otherNumAtRisk': 72, 'otherNumAffected': 21, 'seriousNumAtRisk': 72, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Juvéderm Nasolabial Folds (NLFs)', 'description': 'Nasolabial folds on the corresponding side of the face injected with Juvederm', 'otherNumAtRisk': 72, 'otherNumAffected': 20, 'seriousNumAtRisk': 72, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Injection side induration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Injection site nodule', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 12, 'numAffected': 12}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Injection site discoloration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Application site bruising', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Injection site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Injection site edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Procedural Pain Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Juvéderm Lidocaine Nasolabial Folds (NLFs)', 'description': 'Nasolabial folds on one side of the face injected with the Juvederm formulation with lidocaine'}, {'id': 'OG001', 'title': 'Juvéderm Nasolabial Folds (NLFs)', 'description': 'Nasolabial folds on the corresponding side of the face injected with Juvederm'}], 'classes': [{'categories': [{'measurements': [{'value': '2.0', 'spread': '1.71', 'groupId': 'OG000'}, {'value': '5.4', 'spread': '2.23', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 day', 'description': 'Evaluate pain on an 11-point scale, where 0 is no pain and 10 is the worst pain imaginable.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'populationDescription': 'Intention to treat (ITT)'}, {'type': 'SECONDARY', 'title': 'Comparative Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Total Study Participants', 'description': 'Subjects who received Juvéderm with Lidocaine in one nasolabial fold and Juvéderm without Lidocaine in the other nasolabial fold.'}], 'classes': [{'title': 'Juvéderm Lidocaine is Less Painful than Juvéderm', 'categories': [{'measurements': [{'value': '64', 'groupId': 'OG000'}]}]}, {'title': 'Juvéderm Lidocaine is Slightly Less Painful', 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}]}]}, {'title': 'No Difference', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Juvéderm Lidocaine is Slightly More Painful', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Juvéderm Lidocaine is More Painful than Juvéderm', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 day', 'description': 'A 5-point scale (-2 = Right NLF more painful than Left NLF; -1 = Right NLF slightly more painful than Left NLF; 0 = No difference; 1 = Left NLF slightly more painful than Right NLF; 2 = Left NLF more painful than Right NLF). Subjects selected one category from the scale; the percentage of subjects that selected each category is presented.', 'unitOfMeasure': 'Percent of Participants', 'populationDescription': 'ITT'}, {'type': 'SECONDARY', 'title': 'Nasolabial Fold (NLF) Severity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Juvéderm Lidocaine NLFs', 'description': 'Nasolabial folds on one side of the face injected with the Juvederm formulation with lidocaine'}, {'id': 'OG001', 'title': 'Juvéderm NLFs', 'description': 'Nasolabial folds on the corresponding side of the face injected with Juvederm'}], 'classes': [{'title': 'Improvement using Juvederm Ultra', 'categories': [{'measurements': [{'value': '1.6', 'spread': '0.60', 'groupId': 'OG000'}, {'value': '1.6', 'spread': '0.56', 'groupId': 'OG001'}]}]}, {'title': 'Improvement using Juvederm Ultra Plus', 'categories': [{'measurements': [{'value': '1.8', 'spread': '0.58', 'groupId': 'OG000'}, {'value': '1.8', 'spread': '0.65', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 weeks', 'description': 'Determination of improvement in NLF severity score on 5-point NLF Severity Scale (0 = None; 1 = Mild; 2 = Moderate; 3 = Severe; 4 = Extreme) two weeks after treatment with Juvederm with Lidocaine (either Ultra or Ultra Plus) in one nasolabial fold and Juvederm (either Ultra or Ultra Plus) in the other nasolabial fold.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'populationDescription': 'ITT'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Total Study Participants', 'description': 'Subjects who received Juvederm with Lidocaine in one nasolabial fold and Juvederm without Lidocaine in the other nasolabial fold'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '72'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '72'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'Other aesthetic procedures and products were not allowed 1 month prior to study entry or any time during the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Total Study Participants', 'description': 'Subjects who received Juvéderm with Lidocaine in one nasolabial fold and Juvéderm without Lidocaine in the other nasolabial fold.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '67', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '51.9', 'spread': '9.03', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '69', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '72', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 72}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-12', 'completionDateStruct': {'date': '2008-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-10-06', 'studyFirstSubmitDate': '2008-04-02', 'resultsFirstSubmitDate': '2009-07-22', 'studyFirstSubmitQcDate': '2008-04-02', 'lastUpdatePostDateStruct': {'date': '2014-10-13', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2009-11-30', 'studyFirstPostDateStruct': {'date': '2008-04-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2009-12-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Procedural Pain Score', 'timeFrame': '1 day', 'description': 'Evaluate pain on an 11-point scale, where 0 is no pain and 10 is the worst pain imaginable.'}], 'secondaryOutcomes': [{'measure': 'Comparative Pain', 'timeFrame': '1 day', 'description': 'A 5-point scale (-2 = Right NLF more painful than Left NLF; -1 = Right NLF slightly more painful than Left NLF; 0 = No difference; 1 = Left NLF slightly more painful than Right NLF; 2 = Left NLF more painful than Right NLF). Subjects selected one category from the scale; the percentage of subjects that selected each category is presented.'}, {'measure': 'Nasolabial Fold (NLF) Severity', 'timeFrame': '2 weeks', 'description': 'Determination of improvement in NLF severity score on 5-point NLF Severity Scale (0 = None; 1 = Mild; 2 = Moderate; 3 = Severe; 4 = Extreme) two weeks after treatment with Juvederm with Lidocaine (either Ultra or Ultra Plus) in one nasolabial fold and Juvederm (either Ultra or Ultra Plus) in the other nasolabial fold.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Aesthetic correction'], 'conditions': ['Nasolabial Folds']}, 'referencesModule': {'references': [{'pmid': '19735519', 'type': 'RESULT', 'citation': 'Weinkle SH, Bank DE, Boyd CM, Gold MH, Thomas JA, Murphy DK. A multi-center, double-blind, randomized controlled study of the safety and effectiveness of Juvederm injectable gel with and without lidocaine. J Cosmet Dermatol. 2009 Sep;8(3):205-10. doi: 10.1111/j.1473-2165.2009.00451.x.'}]}, 'descriptionModule': {'briefSummary': 'Safety and effectiveness of JUVÉDERM™ Injectable Gel with Lidocaine compared to JUVÉDERM™ without Lidocaine for procedural pain in the treatment of nasolabial folds.', 'detailedDescription': 'Controlled, randomized, split-face study in which subjects receive JUVÉDERM™ Injectable Gel with Lidocaine (Ultra or Ultra Plus) in one nasolabial fold and JUVÉDERM™ Injectable Gel without Lidocaine (Ultra or Ultra Plus) in the other nasolabial fold. The investigator determines whether the subject receives JUVÉDERM™ Ultra or Ultra Plus per the level of correction desired; the lidocaine assignment is randomized.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Be male or female, 18 years of age or older\n* Desire correction of moderate to severe nasolabial folds (NLFs)\n* Have approximately symmetrical NLFs, i.e., both NLFs have the same pretreatment NLF severity score\n\nExclusion Criteria:\n\n* Have undergone cosmetic facial procedures in the lower 2/3 of the face within 1 month prior to entry in the study or are planning to undergo these procedure during the study.\n* Begin use of any new over-the-counter or prescription, oral or topical, anti-wrinkle products in the NLF area within 1 month prior to enrollment or are planning to begin use of such products during the study.\n* Have undergone previous hyaluronic acid (HA)-based dermal filler treatments such that the total volume of HA injected within 12 months prior to study entry is within 5 mL of the recommended annual maximum volume for HA dermal fillers.\n* Has ever received semi-permanent fillers or permanent facial implants anywhere in the face or neck, or is planning to be implanted with these products during the study.\n* Have a history of anaphylaxis, multiple severe allergies, atopy, or allergy to lidocaine (or any amide-based anesthetic), hyaluronic acid products, or Streptococcal protein, or have plans to undergo desensitization therapy during the term of the study.\n* Have an active inflammation, infection, cancerous or pre-cancerous lesion, or unhealed wound in the NLF area'}, 'identificationModule': {'nctId': 'NCT00653861', 'briefTitle': 'Safety and Effectiveness of JUVÉDERM™ Injectable Gel With Lidocaine', 'organization': {'class': 'INDUSTRY', 'fullName': 'Allergan'}, 'orgStudyIdInfo': {'id': 'JULIDO-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Juvederm with Lidocaine', 'description': "Subjects receive Juvederm with Lidocaine (either Ultra or Ultra Plus at investigator's discretion) in one nasolabial fold.", 'interventionNames': ['Device: JUVÉDERM™ Injectable Gel with Lidocaine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Juvederm', 'description': "Subjects receive Juvederm without Lidocaine (either Ultra or Ultra Plus at investigator's discretion) in the other nasolabial fold.", 'interventionNames': ['Device: JUVÉDERM™ Injectable Gel']}], 'interventions': [{'name': 'JUVÉDERM™ Injectable Gel with Lidocaine', 'type': 'DEVICE', 'description': 'Single treatment, volume determined by investigator', 'armGroupLabels': ['Juvederm with Lidocaine']}, {'name': 'JUVÉDERM™ Injectable Gel', 'type': 'DEVICE', 'description': 'Single treatment, volume determined by investigator', 'armGroupLabels': ['Juvederm']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Mount Kisco', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 41.20426, 'lon': -73.72708}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Allergan Medical', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}