Ignite Creation Date:
2025-12-24 @ 9:09 PM
Ignite Modification Date:
2025-12-25 @ 6:59 PM
Study NCT ID:
NCT03519204
Status:
COMPLETED
Last Update Posted:
2019-08-06
First Post:
2018-04-26
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Safety and Effectiveness of JUVÉDERM® VOLBELLA® With Lidocaine for Lip Enhancement in Chinese Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@allergan.com', 'phone': '714-246-4500', 'title': 'Therapeutic Area, Head', 'organization': 'Allergan'}, 'certainAgreement': {'otherDetails': 'A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Baseline up to Month 12 Post Treatment', 'description': 'Safety population included all participants randomized to the treatment group who received at least 1 study treatment and all participants randomized to the control group, as treated. 29 participants in the No-treatment Control arm received JUVÉDERM® VOLBELLA® XC with Lidocaine after 3 months and are included in the JUVÉDERM® VOLBELLA® XC with Lidocaine arm.', 'eventGroups': [{'id': 'EG000', 'title': 'No-treatment Control (Control Period)', 'description': 'No-treatment was administered during control period.', 'otherNumAtRisk': 40, 'deathsNumAtRisk': 40, 'otherNumAffected': 1, 'seriousNumAtRisk': 40, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'JUVÉDERM® VOLBELLA® XC With Lidocaine (All Treated)', 'description': 'JUVÉDERM® VOLBELLA® XC with lidocaine injected into lips at Day 1. Participants were eligible to receive optional touch-up retreatment one month following initial treatment if applicable.\n\nIncludes 29 participants in the No-treatment Control arm who received treatment with JUVÉDERM® VOLBELLA® XC with Lidocaine injected into lips after 3 months.', 'otherNumAtRisk': 165, 'deathsNumAtRisk': 165, 'otherNumAffected': 40, 'seriousNumAtRisk': 165, 'deathsNumAffected': 0, 'seriousNumAffected': 5}], 'otherEvents': [{'term': 'Injection site induration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 165, 'numAffected': 24}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Injection site mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 165, 'numAffected': 10}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 165, 'numAffected': 16}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}], 'seriousEvents': [{'term': 'Injection site ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 165, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Intervertebral disc protrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 165, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Uterine leiomyoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 165, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Cervical dysplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 165, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Endometriosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 165, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Ovarian cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 165, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Ovarian cyst torsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 165, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': "Percentage of Participants With a ≥1-point Increase (Improvement) on the Evaluating Investigator's (EI's) Assessed 5-point Lip Fullness Scale (LFS)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'No-treatment Control', 'description': 'No-treatment was administered during control period.'}, {'id': 'OG001', 'title': 'JUVÉDERM® VOLBELLA® XC With Lidocaine', 'description': 'JUVÉDERM® VOLBELLA® XC with lidocaine injected into lips at Day 1. Participants were eligible to receive optional touch-up retreatment one month following initial treatment if applicable.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '11.9'}, {'value': '84.7', 'groupId': 'OG001', 'lowerLimit': '77.0', 'upperLimit': '90.7'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Responder Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '84.7', 'ciLowerLimit': '68.2', 'ciUpperLimit': '94.2', 'pValueComment': "P-value was based on 2-sided Fisher's exact test comparing responder rate between treatment group and no-treated control group.", 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to Month 3 Post Last Treatment (JUVÉDERM® VOLBELLA® XC with Lidocaine arm) or Month 3 Post Randomization (No-treatment Control arm)', 'description': "The investigator assessed the participant's lip fullness using the 5-point LFS where: 0=Minimal (Flat or nearly flat contour, minimal red lip show), 1=Mild (Some red lip show; no lower lip pout), 2=Moderate (Moderate red lip show with slight lower lip pout), 3=Marked (Significant red lip show and lower lip pout), and 4=Very Marked (Very significant red lip show, lower lip pout, and upper lip pout). Improvement was defined as a ≥1-point increase in fullness from Baseline. Number analyzed is the number of participants with data available for analysis at Baseline and Month 3.", 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population included all participants who were randomized to study treatment (treatment group), received at least 1 study device treatment, and had baseline and at least 1 posttreatment assessment of primary variable, and who were randomized to no-treatment control group had baseline and at least 1 follow-up assessment of primary variable.'}, {'type': 'SECONDARY', 'title': "Percentage of Participants With a ≥1-point Increase (Improvement) Based on the Participant's Assessed 5-point LFS", 'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'JUVÉDERM® VOLBELLA® XC With Lidocaine', 'description': 'JUVÉDERM® VOLBELLA® XC with lidocaine injected into lips at Day 1. Participants were eligible to receive optional touch-up retreatment one month following initial treatment if applicable.'}], 'classes': [{'categories': [{'measurements': [{'value': '65.0', 'groupId': 'OG000', 'lowerLimit': '55.6', 'upperLimit': '73.5'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to Month 3 Post Treatment', 'description': 'Lip fullness was assessed by the participant using the 5-point LFS where: 0=Minimal (Flat or nearly flat contour, minimal red lip show), 1=Mild (Some red lip show; no lower lip pout), 2=Moderate (Moderate red lip show with slight lower lip pout), 3=Marked (Significant red lip show and lower lip pout), and 4=Very Marked (Very significant red lip show, lower lip pout, and upper lip pout). Improvement was defined as a ≥1-point increase in fullness from Baseline. Number analyzed is the number of participants with data available for analysis at Baseline and Month 3.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population included all participants who were randomized to study treatment (treatment group), received at least 1 study device treatment, and had baseline and at least 1 posttreatment assessment of the primary variable. As per protocol, analysis for this Outcome Measure was for the Treatment arm only.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Overall Lip Volume', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'No-treatment Control', 'description': 'No-treatment was administered during control period.'}, {'id': 'OG001', 'title': 'JUVÉDERM® VOLBELLA® XC With Lidocaine', 'description': 'JUVÉDERM® VOLBELLA® XC with lidocaine injected into lips at Day 1. Participants were eligible to receive optional touch-up retreatment one month following initial treatment if applicable.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.03990', 'groupId': 'OG000', 'lowerLimit': '-2.2055', 'upperLimit': '0.5676'}, {'value': '0.45150', 'groupId': 'OG001', 'lowerLimit': '-0.8456', 'upperLimit': '1.9478'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Median Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.55800', 'ciLowerLimit': '0.34470', 'ciUpperLimit': '0.77390', 'pValueComment': 'P-value was computed using Wilcoxon test with normal approximation.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.109492', 'estimateComment': 'The median difference (the location shift) and its 95% CI were computed using Hodges-Lehmann estimation associated with Wilcoxon statistics.', 'statisticalMethod': 'Wilcoxon Rank-sum Test', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline to Month 3 Post Treatment ( JUVÉDERM® VOLBELLA® XC with Lidocaine arm) or Month 3 Post Randomization (No-treatment Control arm)', 'description': 'Overall lip volume was measured by 3-dimensional (3D) photography images. A positive change from Baseline indicates improvement. Number analyzed is the number of participants with data available for analysis at Baseline and Month 3.', 'unitOfMeasure': 'cubic centimeters (cc)', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population included all participants who were randomized to study treatment (treatment group), received at least 1 study device treatment, and had baseline and at least 1 posttreatment assessment of primary variable, and who were randomized to no-treatment control group had baseline and at least 1 follow-up assessment of primary variable.'}, {'type': 'SECONDARY', 'title': 'Percentage Change From Baseline in Lip Surface Area', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'No-treatment Control', 'description': 'No-treatment was administered during control period.'}, {'id': 'OG001', 'title': 'JUVÉDERM® VOLBELLA® XC With Lidocaine', 'description': 'JUVÉDERM® VOLBELLA® XC with lidocaine injected into lips at Day 1. Participants were eligible to receive optional touch-up retreatment one month following initial treatment if applicable.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.11', 'groupId': 'OG000', 'lowerLimit': '-21.5', 'upperLimit': '20.1'}, {'value': '12.16', 'groupId': 'OG001', 'lowerLimit': '-9.5', 'upperLimit': '76.9'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Median Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '13.04', 'ciLowerLimit': '8.861', 'ciUpperLimit': '17.180', 'pValueComment': 'P-value was computed using Wilcoxon test with normal approximation.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.122', 'estimateComment': 'The median difference (the location shift) and its 95% CI were computed using Hodges-Lehmann estimation associated with Wilcoxon statistics.', 'statisticalMethod': 'Wilcoxon Rank-sum Test', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline to Month 3 Post Treatment ( JUVÉDERM® VOLBELLA® XC with Lidocaine arm) or Month 3 Post Randomization (No-treatment Control arm)', 'description': 'Lips surface area was measured by 3D photography images. A positive percentage change from Baseline indicates improvement. Number analyzed is the number of participants with data available for analysis at Baseline and Month 3.', 'unitOfMeasure': 'percentage change in lip surface area', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population included all participants who were randomized to study treatment (treatment group), received at least 1 study device treatment, and had baseline and at least 1 posttreatment assessment of primary variable, and who were randomized to no-treatment control group had baseline and at least 1 follow-up assessment of primary variable.'}, {'type': 'SECONDARY', 'title': 'Procedural Pain Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '136', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treated Control', 'description': 'No-treatment was administered during control period. After 3 months, participants received treatment with JUVÉDERM® VOLBELLA® XC with lidocaine if applicable followed by an optional touch-up retreatment one month following initial treatment.'}, {'id': 'OG001', 'title': 'JUVÉDERM® VOLBELLA® XC With Lidocaine', 'description': 'JUVÉDERM® VOLBELLA® XC with lidocaine injected into lips at Day 1. Participants were eligible to receive optional touch-up retreatment one month following initial treatment if applicable.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.6', 'spread': '1.86', 'groupId': 'OG000'}, {'value': '2.6', 'spread': '1.69', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 30 days after initial treatment with JUVÉDERM® VOLBELLA® XC with Lidocaine', 'description': 'Procedural pain (pain during injection) was evaluated by the participant using an 11-point scale, where: 0=No pain to 10=Worst pain imaginable. Participants recorded procedural pain in safety diary for 30 days after initial treatment. Number analyzed is the number of participants with safety diary data available for analysis.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants randomized to the treatment group who received at least 1 study treatment and all participants randomized to the control group, as treated. Analysis excludes 11 participants in the No-treatment Control group who did not receive JUVÉDERM® VOLBELLA®.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Injection Site Responses (ISRs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '136', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treated Control', 'description': 'No-treatment was administered during control period. After 3 months, participants received treatment with JUVÉDERM® VOLBELLA® XC with lidocaine if applicable followed by an optional touch-up retreatment one month following initial treatment.'}, {'id': 'OG001', 'title': 'JUVÉDERM® VOLBELLA® XC With Lidocaine', 'description': 'JUVÉDERM® VOLBELLA® XC with lidocaine injected into lips at Day 1. Participants were eligible to receive optional touch-up retreatment one month following initial treatment if applicable.'}], 'classes': [{'title': 'Initial Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}]}]}, {'title': 'Touch-up Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 30 days after each treatment with JUVÉDERM® VOLBELLA® XC with Lidocaine', 'description': 'ISRs were recorded by the participant in a safety diary for 30 days after each treatment and were summarized by treatment (initial and touch-up). ISRs were defined as redness, pain after injection, tenderness to touch, firmness, swelling, lumps/bumps, bruising, itching and discoloration. Number analyzed is the number of participants with safety diary data available for analysis.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants randomized to the treatment group who received at least 1 study treatment and all participants randomized to the control group, as treated. Analysis excludes 11 participants in the No-treatment Control group who did not receive JUVÉDERM® VOLBELLA® XC with Lidocaine.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment-emergent Adverse Events (TEAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '165', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'No-treatment Control (Control Period)', 'description': 'No-treatment was administered during control period.'}, {'id': 'OG001', 'title': 'JUVÉDERM® VOLBELLA® XC With Lidocaine (All Treated)', 'description': 'JUVÉDERM® VOLBELLA® XC with lidocaine injected into lips at Day 1. Participants were eligible to receive optional touch-up retreatment one month following initial treatment if applicable.\n\nIncludes 29 participants in the No-treatment Control arm who received treatment with JUVÉDERM® VOLBELLA® XC with Lidocaine injected into lips after 3 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline to Month 12 Post Treatment', 'description': 'An Adverse event (AE) is any untoward medical occurrence in a patient or a participant using an investigational drug, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. A TEAE is an AE that occurred after receiving the first dose of study device or study injection or an AE present prior to first dose but increased in severity during the Treatment Period.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants randomized to the treatment group who received at least 1 study treatment and all participants randomized to the control group, as treated.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'No-treatment Control', 'description': 'No-treatment was administered during control period. After 3 months, participants were eligible to receive treatment with JUVÉDERM® VOLBELLA® XC with lidocaine if applicable followed by an optional touch-up retreatment one month following initial treatment.'}, {'id': 'FG001', 'title': 'JUVÉDERM® VOLBELLA® XC With Lidocaine', 'description': 'JUVÉDERM® VOLBELLA® XC with lidocaine injected into lips at Day 1. Participants were eligible to receive optional touch-up retreatment one month following initial treatment if applicable.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': '3 control participants were treated in error; 29 participants received treatment after 3 months.', 'groupId': 'FG000', 'numSubjects': '43'}, {'groupId': 'FG001', 'numSubjects': '133'}]}, {'type': 'mITT Population', 'achievements': [{'groupId': 'FG000', 'numSubjects': '33'}, {'groupId': 'FG001', 'numSubjects': '130'}]}, {'type': 'Safety Population', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}, {'groupId': 'FG001', 'numSubjects': '136'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '118'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '15'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'Other Miscellaneous Reasons', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'Three participants were randomized to the no-treatment control group but were treated in error on the day of randomization and were included in the treatment group for the Modified-intent-to-treat (mITT) population and the Safety population for analysis.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'BG000'}, {'value': '130', 'groupId': 'BG001'}, {'value': '163', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'No-treatment Control', 'description': 'No-treatment was administered during control period. After 3 months, participants were eligible to receive treatment with JUVÉDERM® VOLBELLA® XC with lidocaine if applicable followed by an optional touch-up retreatment one month following initial treatment.'}, {'id': 'BG001', 'title': 'JUVÉDERM® VOLBELLA® XC With Lidocaine', 'description': 'JUVÉDERM® VOLBELLA® XC with lidocaine injected into lips at Day 1. Participants were eligible to receive optional touch-up retreatment one month following initial treatment if applicable.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '35.0', 'spread': '8.40', 'groupId': 'BG000'}, {'value': '35.0', 'spread': '9.83', 'groupId': 'BG001'}, {'value': '35.0', 'spread': '9.53', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '127', 'groupId': 'BG001'}, {'value': '158', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Asian', 'categories': [{'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '130', 'groupId': 'BG001'}, {'value': '163', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Chinese', 'categories': [{'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '130', 'groupId': 'BG001'}, {'value': '163', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Lip Fullness Scale (LFS) Score as Assessed by Evaluating Investigator (EI)', 'classes': [{'title': 'Minimal', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}, {'title': 'Mild', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '75', 'groupId': 'BG002'}]}]}, {'title': 'Moderate', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '79', 'groupId': 'BG002'}]}]}, {'title': 'Marked', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Very Marked', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': "The investigator assessed the participant's lip fullness using a 5-point scale where: 0=Minimal (Flat or nearly flat contour, minimal red lip show), 1=Mild (Some red lip show; no lower lip pout), 2=Moderate (Moderate red lip show with slight lower lip pout), 3=Marked (Significant red lip show and lower lip pout), and 4=Very Marked (Very significant red lip show, lower lip pout, and upper lip pout).", 'unitOfMeasure': 'Participants', 'populationDescription': 'mITT population included all participants who were randomized to study treatment (treatment group), received at least 1 study device treatment, and had baseline and at least 1 posttreatment assessment of primary variable, and who were randomized to no-treatment control group had baseline and at least 1 follow-up assessment of primary variable.'}], 'populationDescription': 'mITT population included all participants who were randomized to study treatment (treatment group), received at least 1 study device treatment, and had baseline and at least 1 posttreatment assessment of primary variable, and who were randomized to no-treatment control group had baseline and at least 1 follow-up assessment of primary variable.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-07-16', 'size': 622095, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_000.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2019-03-28T17:48', 'hasProtocol': False}, {'date': '2015-07-29', 'size': 791236, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_001.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-03-28T17:48', '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': 176}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2018-03-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-25', 'studyFirstSubmitDate': '2018-04-26', 'resultsFirstSubmitDate': '2019-03-28', 'studyFirstSubmitQcDate': '2018-04-26', 'lastUpdatePostDateStruct': {'date': '2019-08-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-03-28', 'studyFirstPostDateStruct': {'date': '2018-05-08', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2019-06-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-03-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Percentage of Participants With a ≥1-point Increase (Improvement) on the Evaluating Investigator's (EI's) Assessed 5-point Lip Fullness Scale (LFS)", 'timeFrame': 'Baseline to Month 3 Post Last Treatment (JUVÉDERM® VOLBELLA® XC with Lidocaine arm) or Month 3 Post Randomization (No-treatment Control arm)', 'description': "The investigator assessed the participant's lip fullness using the 5-point LFS where: 0=Minimal (Flat or nearly flat contour, minimal red lip show), 1=Mild (Some red lip show; no lower lip pout), 2=Moderate (Moderate red lip show with slight lower lip pout), 3=Marked (Significant red lip show and lower lip pout), and 4=Very Marked (Very significant red lip show, lower lip pout, and upper lip pout). Improvement was defined as a ≥1-point increase in fullness from Baseline. Number analyzed is the number of participants with data available for analysis at Baseline and Month 3."}], 'secondaryOutcomes': [{'measure': "Percentage of Participants With a ≥1-point Increase (Improvement) Based on the Participant's Assessed 5-point LFS", 'timeFrame': 'Baseline to Month 3 Post Treatment', 'description': 'Lip fullness was assessed by the participant using the 5-point LFS where: 0=Minimal (Flat or nearly flat contour, minimal red lip show), 1=Mild (Some red lip show; no lower lip pout), 2=Moderate (Moderate red lip show with slight lower lip pout), 3=Marked (Significant red lip show and lower lip pout), and 4=Very Marked (Very significant red lip show, lower lip pout, and upper lip pout). Improvement was defined as a ≥1-point increase in fullness from Baseline. Number analyzed is the number of participants with data available for analysis at Baseline and Month 3.'}, {'measure': 'Change From Baseline in Overall Lip Volume', 'timeFrame': 'Baseline to Month 3 Post Treatment ( JUVÉDERM® VOLBELLA® XC with Lidocaine arm) or Month 3 Post Randomization (No-treatment Control arm)', 'description': 'Overall lip volume was measured by 3-dimensional (3D) photography images. A positive change from Baseline indicates improvement. Number analyzed is the number of participants with data available for analysis at Baseline and Month 3.'}, {'measure': 'Percentage Change From Baseline in Lip Surface Area', 'timeFrame': 'Baseline to Month 3 Post Treatment ( JUVÉDERM® VOLBELLA® XC with Lidocaine arm) or Month 3 Post Randomization (No-treatment Control arm)', 'description': 'Lips surface area was measured by 3D photography images. A positive percentage change from Baseline indicates improvement. Number analyzed is the number of participants with data available for analysis at Baseline and Month 3.'}, {'measure': 'Procedural Pain Score', 'timeFrame': 'Up to 30 days after initial treatment with JUVÉDERM® VOLBELLA® XC with Lidocaine', 'description': 'Procedural pain (pain during injection) was evaluated by the participant using an 11-point scale, where: 0=No pain to 10=Worst pain imaginable. Participants recorded procedural pain in safety diary for 30 days after initial treatment. Number analyzed is the number of participants with safety diary data available for analysis.'}, {'measure': 'Number of Participants With Injection Site Responses (ISRs)', 'timeFrame': 'Up to 30 days after each treatment with JUVÉDERM® VOLBELLA® XC with Lidocaine', 'description': 'ISRs were recorded by the participant in a safety diary for 30 days after each treatment and were summarized by treatment (initial and touch-up). ISRs were defined as redness, pain after injection, tenderness to touch, firmness, swelling, lumps/bumps, bruising, itching and discoloration. Number analyzed is the number of participants with safety diary data available for analysis.'}, {'measure': 'Number of Participants With Treatment-emergent Adverse Events (TEAEs)', 'timeFrame': 'Baseline to Month 12 Post Treatment', 'description': 'An Adverse event (AE) is any untoward medical occurrence in a patient or a participant using an investigational drug, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. A TEAE is an AE that occurred after receiving the first dose of study device or study injection or an AE present prior to first dose but increased in severity during the Treatment Period.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lip Enhancement']}, 'referencesModule': {'references': [{'pmid': '36387967', 'type': 'DERIVED', 'citation': 'Li D, Gao Z, Sun J, Li Q, Jiang P, Zhang L, Chawla S. Safe and Effective Lip Enhancement with VYC-15L in Chinese Adults. Clin Cosmet Investig Dermatol. 2022 Nov 10;15:2427-2436. doi: 10.2147/CCID.S382194. eCollection 2022.'}], 'seeAlsoLinks': [{'url': 'http://AllerganClinicalTrials.com', 'label': 'Additional information on study locations near you may be found at AllerganClinicalTrials.com. For any study not on AllerganClinicalTrials.com, please contact IR-CTRegistration@Allergan.com for assistance.'}]}, 'descriptionModule': {'briefSummary': 'This study will evaluate the safety and effectiveness of VOLBELLA with Lidocaine injectable gel in Chinese adults seeking lip enhancement.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female, 18 years of age or older with an overall baseline Lip Fullness Scale (LFS) score of minimal, mild or moderate on the 5-point LFS scale.\n* Has the ability to follow study instructions and is likely to complete all required visits\n\nExclusion Criteria:\n\n* Has had any facial procedures or trauma that may interfere with the study procedures and results\n* Is on anti-coagulation therapy or other contraindicated treatments\n* Has current cutaneous inflammatory or infectious processes or lesions in the mouth area'}, 'identificationModule': {'nctId': 'NCT03519204', 'briefTitle': 'Safety and Effectiveness of JUVÉDERM® VOLBELLA® With Lidocaine for Lip Enhancement in Chinese Adults', 'organization': {'class': 'INDUSTRY', 'fullName': 'Allergan'}, 'officialTitle': 'A Randomized, Multicenter, No-treatment Controlled Study of the Safety and Effectiveness of JUVÉDERM® VOLBELLA® With Lidocaine for Lip Enhancement in Chinese Adults', 'orgStudyIdInfo': {'id': 'VOLBELLA-005'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'JUVÉDERM® VOLBELLA® XC with Lidocaine', 'description': 'JUVÉDERM® VOLBELLA® XC with lidocaine injected into lips at Day 1. Participants were eligible to receive optional touch-up retreatment one month following initial treatment if applicable.', 'interventionNames': ['Device: JUVÉDERM® VOLBELLA® XC with Lidocaine']}, {'type': 'EXPERIMENTAL', 'label': 'No-treatment Control', 'description': 'No-treatment was administered during control period. After 3 months, participants were eligible to receive treatment with JUVÉDERM® VOLBELLA® XC with lidocaine if applicable followed by an optional touch-up retreatment one month following initial treatment.', 'interventionNames': ['Device: JUVÉDERM® VOLBELLA® XC with Lidocaine', 'Other: No-treatment Control']}], 'interventions': [{'name': 'JUVÉDERM® VOLBELLA® XC with Lidocaine', 'type': 'DEVICE', 'description': 'JUVÉDERM® VOLBELLA® XC with lidocaine injected into lips.', 'armGroupLabels': ['JUVÉDERM® VOLBELLA® XC with Lidocaine', 'No-treatment Control']}, {'name': 'No-treatment Control', 'type': 'OTHER', 'description': 'No-treatment was administered.', 'armGroupLabels': ['No-treatment Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510010', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'General Hospital of Southern Theatre Command', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '510515', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'Nanfang Hospital, Southern Medical University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '430000', 'city': 'Wuhan', 'state': 'Hubei', 'country': 'China', 'facility': 'Union Hospital Tongji Medical College Huazhong University of Science and Technology', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}, {'zip': '100029', 'city': 'Beijing', 'country': 'China', 'facility': 'China-Japan Friendship Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100083', 'city': 'Beijing', 'country': 'China', 'facility': 'Peking University Third Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'overallOfficials': [{'name': 'Smita Chawla', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Allergan'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Allergan', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}