Ignite Creation Date:
2025-12-25 @ 1:25 AM
Ignite Modification Date:
2025-12-27 @ 3:48 AM
Study NCT ID:
NCT04206293
Status:
COMPLETED
Last Update Posted:
2021-08-26
First Post:
2019-12-18
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Evaluate The Impact on Skin Quality Attributes by Juvederm® Volite Injection on Healthy Volunteers
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': 'First dose of study treatment to end of the study (Up to 9 months)', 'description': 'All-Cause Mortality included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Population included any participant having used the tested device.', 'eventGroups': [{'id': 'EG000', 'title': 'Juvéderm® VOLITE Treated Zone', 'description': 'Participants received Juvéderm® VOLITE, intradermal injection on a zone of 8 cm x 4 cm (32 cm\\^2) of the volar left forearm on Day 0. The dose to be injected was decided by the investigator as per the Directions for Use. A maximum of 1 mL was injected on the zone treated.', 'otherNumAtRisk': 11, 'deathsNumAtRisk': 11, 'otherNumAffected': 5, 'seriousNumAtRisk': 11, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Herpes virus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Oral herpes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Burning sensation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Skin tightness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Skin Hydration as Measured by MoistureMeterD® 0.5 mm', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Juvéderm® VOLITE Treated Zone', 'description': 'Participants received Juvéderm® VOLITE, intradermal injection on a zone of 8 cm x 4 cm (32 cm\\^2) of the volar left forearm on Day 0. The dose to be injected was decided by the investigator as per the Directions for Use. A maximum of 1 mL was injected on the zone treated.'}, {'id': 'OG001', 'title': 'Non-Treated Zone', 'description': 'The not-treated zone of the same arm in same the participant served as a control.'}], 'classes': [{'title': 'Change from Baseline to Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.7', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '-0.0', 'spread': '0.7', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline to Day 84', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.2', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '0.6', 'spread': '0.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0736', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares (LS) Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.7', 'ciLowerLimit': '-0.2', 'ciUpperLimit': '3.6', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.9', 'groupDescription': 'Change from Baseline to Day 28', 'statisticalMethod': 'Mixed ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.'}, {'pValue': '0.5259', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.7', 'ciLowerLimit': '-1.5', 'ciUpperLimit': '2.8', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.0', 'groupDescription': 'Change from Baseline to Day 84', 'statisticalMethod': 'Mixed ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline [Day 0 (D0)] to Days 28 (D28) and 84 (D84)', 'description': 'Skin hydration was measured using MoistureMeterD® XS (for epidermis and dermis), a non-invasive probe which measures the dielectric constant of the skin at a depth of 0.5 mm. 5 measurements were done on the same zone and the average value was calculated, expressed as tissue dielectric constant (TDC). The TDC is directly proportional to the amount of water in the tissue. A positive change from Baseline indicates better skin hydration. Values were obtained from a mixed analysis of variance (ANOVA) model. The data is presented for area treated with Juvéderm® VOLITE and non-treated area in the same participants.', 'unitOfMeasure': 'tissue dielectric constant', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) included any participant included in the study with at least a post-baseline value. Number analyzed is the number of participants with data available for analyses at the given timepoint.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Skin Hydration as Measured by MoistureMeter D® 1.5 mm', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Juvéderm® VOLITE Treated Zone', 'description': 'Participants received Juvéderm® VOLITE, intradermal injection on a zone of 8 cm x 4 cm (32 cm\\^2) of the volar left forearm on Day 0. The dose to be injected was decided by the investigator as per the Directions for Use. A maximum of 1 mL was injected on the zone treated.'}, {'id': 'OG001', 'title': 'Non-Treated Zone', 'description': 'The not-treated zone of the same arm in same the participant served as a control.'}], 'classes': [{'title': 'Change from Baseline to Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.8', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '1.0', 'spread': '1.0', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline to Day 84', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.4', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '1.4', 'spread': '0.6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.8848', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.2', 'ciLowerLimit': '-2.8', 'ciUpperLimit': '2.4', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.2', 'groupDescription': 'Change from Baseline to Day 28', 'statisticalMethod': 'Mixed ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.'}, {'pValue': '0.9505', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.1', 'ciLowerLimit': '-1.8', 'ciUpperLimit': '1.7', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.8', 'groupDescription': 'Change from Baseline to Day 84', 'statisticalMethod': 'Mixed ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (D0) to D28 and D84', 'description': 'Skin hydration was measured using MoistureMeter D® S15 (for epidermis and dermis), a non-invasive probe which measures the dielectric constant of the skin at a depth of 1.5 mm. 5 measurements were done on the same zone and the average value was calculated, expressed as TDC. The TDC is directly proportional to the amount of water in the tissue. A positive change from Baseline indicates better skin hydration. Values were obtained from a mixed ANOVA model. The data is presented for area treated with Juvéderm® VOLITE and non-treated area in the same participants.', 'unitOfMeasure': 'tissue dielectric constant', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included any participant included in the study with at least a post-baseline value. Number analyzed is the number of participants with data available for analyses at the given timepoint.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Skin Hydration as Measured by Corneometer®', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Juvéderm® VOLITE Treated Zone', 'description': 'Participants received Juvéderm® VOLITE, intradermal injection on a zone of 8 cm x 4 cm (32 cm\\^2) of the volar left forearm on Day 0. The dose to be injected was decided by the investigator as per the Directions for Use. A maximum of 1 mL was injected on the zone treated.'}, {'id': 'OG001', 'title': 'Non-Treated Zone', 'description': 'The not-treated zone of the same arm in same the participant served as a control.'}], 'classes': [{'title': 'Change from Baseline to Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.3', 'spread': '1.1', 'groupId': 'OG000'}, {'value': '-1.4', 'spread': '1.0', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline to Day 84', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.5', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '1.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0007', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.7', 'ciLowerLimit': '1.4', 'ciUpperLimit': '4.0', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.6', 'groupDescription': 'Change from Baseline to Day 28', 'statisticalMethod': 'Mixed ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.'}, {'pValue': '0.0033', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.4', 'ciLowerLimit': '0.9', 'ciUpperLimit': '3.9', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.7', 'groupDescription': 'Change from Baseline to Day 84', 'statisticalMethod': 'Mixed ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (D0) to D28 and D84', 'description': 'Corneometer® measures the hydration level of the superficial skin surface (epidermis). The measurement is based on capacitance measurement of a dielectric medium in this case skin. It uses fringing field capacitance sensors to measure the dielectric constant of the skin. The dielectric constant of skin will change with water content. This allows for any changes in skin hydration to be measured by the precision measuring capacitor. These changes in water content of the stratum corneum are converted into arbitrary units of hydration. 5 measurements were done on the same zone and average value was calculated. Values were obtained from a mixed ANOVA model and expressed in arbitrary units. A positive change from Baseline indicates better skin hydration rate. The data is presented for area treated with Juvéderm® VOLITE and non-treated area in the same participants.', 'unitOfMeasure': 'arbitrary units of hydration', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included any participant included in the study with at least a post-baseline value. Number analyzed is the number of participants with data available for analyses at the given timepoint.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Skin Elasticity Parameters: Uf: Final Deformation (Firmness), Ue: Immediate Extensibility, Ur: Immediate Retraction (Tonicity), Ua: Total Recovery of the Initial State as Measured by Cutometer ®', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Juvéderm® VOLITE Treated Zone', 'description': 'Participants received Juvéderm® VOLITE, intradermal injection on a zone of 8 cm x 4 cm (32 cm\\^2) of the volar left forearm on Day 0. The dose to be injected was decided by the investigator as per the Directions for Use. A maximum of 1 mL was injected on the zone treated.'}, {'id': 'OG001', 'title': 'Non-Treated Zone', 'description': 'The not-treated zone of the same arm in same the participant served as a control.'}], 'classes': [{'title': 'Uf: Change from Baseline to Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.092', 'spread': '0.009', 'groupId': 'OG000'}, {'value': '0.003', 'spread': '0.008', 'groupId': 'OG001'}]}]}, {'title': 'Uf: Change from Baseline to Day 84', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.073', 'spread': '0.009', 'groupId': 'OG000'}, {'value': '-0.003', 'spread': '0.007', 'groupId': 'OG001'}]}]}, {'title': 'Ue: Change from Baseline to Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.094', 'spread': '0.010', 'groupId': 'OG000'}, {'value': '-0.005', 'spread': '0.013', 'groupId': 'OG001'}]}]}, {'title': 'Ue: Change from Baseline to Day 84', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.075', 'spread': '0.008', 'groupId': 'OG000'}, {'value': '0.006', 'spread': '0.009', 'groupId': 'OG001'}]}]}, {'title': 'Ur: Change from Baseline to Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.097', 'spread': '0.015', 'groupId': 'OG000'}, {'value': '-0.018', 'spread': '0.020', 'groupId': 'OG001'}]}]}, {'title': 'Ur: Change from Baseline to Day 84', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.096', 'spread': '0.012', 'groupId': 'OG000'}, {'value': '-0.022', 'spread': '0.015', 'groupId': 'OG001'}]}]}, {'title': 'Ua: Change from Baseline to Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.090', 'spread': '0.015', 'groupId': 'OG000'}, {'value': '-0.009', 'spread': '0.015', 'groupId': 'OG001'}]}]}, {'title': 'Ua: Change from Baseline to Day 84', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.093', 'spread': '0.011', 'groupId': 'OG000'}, {'value': '-0.016', 'spread': '0.010', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.095', 'ciLowerLimit': '-0.119', 'ciUpperLimit': '-0.070', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.011', 'groupDescription': 'Uf: Change from Baseline to Day 28', 'statisticalMethod': 'Mixed ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.071', 'ciLowerLimit': '-0.094', 'ciUpperLimit': '-0.048', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.011', 'groupDescription': 'Uf: Change from Baseline to Day 84', 'statisticalMethod': 'Mixed ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.089', 'ciLowerLimit': '-0.116', 'ciUpperLimit': '-0.061', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.013', 'groupDescription': 'Ue: Change from Baseline to Day 28', 'statisticalMethod': 'Mixed ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.081', 'ciLowerLimit': '-0.102', 'ciUpperLimit': '-0.061', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.009', 'groupDescription': 'Ue: Change from Baseline to Day 84', 'statisticalMethod': 'Mixed ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.'}, {'pValue': '0.0003', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciPctValue': '95', 'paramValue': '-0.079', 'ciLowerLimit': '-0.116', 'ciUpperLimit': '-0.041', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.018', 'groupDescription': 'Ur: Change from Baseline to Day 28', 'statisticalMethod': 'Mixed ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.'}, {'pValue': '0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.074', 'ciLowerLimit': '-0.103', 'ciUpperLimit': '-0.044', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.013', 'groupDescription': 'Ur: Change from Baseline to Day 84', 'statisticalMethod': 'Mixed ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.'}, {'pValue': '0.0002', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.081', 'ciLowerLimit': '-0.117', 'ciUpperLimit': '-0.045', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.017', 'groupDescription': 'Ua: Change from Baseline to Day 28', 'statisticalMethod': 'Mixed ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.077', 'ciLowerLimit': '-0.103', 'ciUpperLimit': '-0.052', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.012', 'groupDescription': 'Ua: Change from Baseline to Day 84', 'statisticalMethod': 'Mixed ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (D0) to D28 and D84', 'description': 'Skin elasticity was measured by a Cutometer ® which uses an in vivo non-invasive method to evaluate biological extensibility and elasticity variations. The various parameters analysed were Uf: final deformation (firmness), Ue: immediate extensibility, Ur: immediate retraction (tonicity), Ua: total recovery of the initial state. 2 measurements were done on the same zone and the average value was calculated. Values were obtained from a mixed ANOVA model. A Negative change from Baseline indicates firmer skin. The data is presented for area treated with Juvéderm® VOLITE and non-treated area in the same participants.', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included any participant included in the study with at least a post-baseline value. Number analyzed is the number of participants with data available for analyses at the given timepoint.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Relative Parameters of Skin Elasticity: Q1, Q2, Q3 as Measured by Cutometer ®', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Juvéderm® VOLITE Treated Zone', 'description': 'Participants received Juvéderm® VOLITE, intradermal injection on a zone of 8 cm x 4 cm (32 cm\\^2) of the volar left forearm on Day 0. The dose to be injected was decided by the investigator as per the Directions for Use. A maximum of 1 mL was injected on the zone treated.'}, {'id': 'OG001', 'title': 'Non-Treated Zone', 'description': 'The not-treated zone of the same arm in same the participant served as a control.'}], 'classes': [{'title': 'Q1: Change from Baseline to Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.025', 'spread': '0.015', 'groupId': 'OG000'}, {'value': '-0.017', 'spread': '0.013', 'groupId': 'OG001'}]}]}, {'title': 'Q1: Change from Baseline to Day 84', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.042', 'spread': '0.012', 'groupId': 'OG000'}, {'value': '-0.018', 'spread': '0.011', 'groupId': 'OG001'}]}]}, {'title': 'Q2: Change from Baseline to Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.045', 'spread': '0.017', 'groupId': 'OG000'}, {'value': '-0.023', 'spread': '0.018', 'groupId': 'OG001'}]}]}, {'title': 'Q2: Change from Baseline to Day 84', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.053', 'spread': '0.014', 'groupId': 'OG000'}, {'value': '-0.019', 'spread': '0.015', 'groupId': 'OG001'}]}]}, {'title': 'Q3: Change from Baseline to Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.019', 'spread': '0.006', 'groupId': 'OG000'}, {'value': '0.006', 'spread': '0.007', 'groupId': 'OG001'}]}]}, {'title': 'Q3: Change from Baseline to Day 84', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.013', 'spread': '0.005', 'groupId': 'OG000'}, {'value': '0.001', 'spread': '0.006', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.5786', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.008', 'ciLowerLimit': '-0.038', 'ciUpperLimit': '0.022', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.014', 'groupDescription': 'Q1: Change from Baseline to Day 28', 'statisticalMethod': 'Mixed ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.'}, {'pValue': '0.0690', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.023', 'ciLowerLimit': '-0.049', 'ciUpperLimit': '0.002', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.012', 'groupDescription': 'Q1: Change from Baseline to Day 84', 'statisticalMethod': 'Mixed ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.'}, {'pValue': '0.1934', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.021', 'ciLowerLimit': '-0.054', 'ciUpperLimit': '0.012', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.016', 'groupDescription': 'Q2: Change from Baseline to Day 28', 'statisticalMethod': 'Mixed ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.'}, {'pValue': '0.0194', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.034', 'ciLowerLimit': '-0.062', 'ciUpperLimit': '-0.006', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.013', 'groupDescription': 'Q2: Change from Baseline to Day 84', 'statisticalMethod': 'Mixed ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.'}, {'pValue': '0.0652', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.013', 'ciLowerLimit': '-0.001', 'ciUpperLimit': '0.028', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.007', 'groupDescription': 'Q3: Change from Baseline to Day 28', 'statisticalMethod': 'Mixed ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.'}, {'pValue': '0.0756', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.012', 'ciLowerLimit': '-0.001', 'ciUpperLimit': '0.024', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.006', 'groupDescription': 'Q3: Change from Baseline to Day 84', 'statisticalMethod': 'Mixed ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (D0) to D28 and D84', 'description': 'The parameters evaluated were: Elastic Recovery (Q1)=elastic recovery area (QE)/maximum recovery area (QO), Viscous Recovery (Q2)=viscous recovery area (QR)/maximum recovery area (QO) and Viscoelastic Recovery (Q3)= (QE+QR)/QO. 2 measurements were done on the same zone and the average value was calculated. Values were obtained from a mixed ANOVA model. A negative change from Baseline in Q1 and Q2 indicates decreased skin elasticity. A positive change from Baseline in Q3 indicates decreased skin elasticity. The data is presented for area treated with Juvéderm® VOLITE and non-treated area in the same participants.', 'unitOfMeasure': 'dimensionless', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included any participant included in the study with at least a post-baseline value. Number analyzed is the number of participants with data available for analyses at the given timepoint.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Skin Elasticity as Measured by Elastimeter®', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Juvéderm® VOLITE Treated Zone', 'description': 'Participants received Juvéderm® VOLITE, intradermal injection on a zone of 8 cm x 4 cm (32 cm\\^2) of the volar left forearm on Day 0. The dose to be injected was decided by the investigator as per the Directions for Use. A maximum of 1 mL was injected on the zone treated.'}, {'id': 'OG001', 'title': 'Non-Treated Zone', 'description': 'The not-treated zone of the same arm in same the participant served as a control.'}], 'classes': [{'title': 'Change from Baseline to Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.45', 'spread': '2.12', 'groupId': 'OG000'}, {'value': '5.00', 'spread': '2.30', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline to Day 84', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.90', 'spread': '3.20', 'groupId': 'OG000'}, {'value': '4.32', 'spread': '3.49', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.8409', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.55', 'ciLowerLimit': '-6.19', 'ciUpperLimit': '5.10', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.68', 'groupDescription': 'Change from Baseline to Day 28', 'statisticalMethod': 'Mixed ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.'}, {'pValue': '0.9183', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.42', 'ciLowerLimit': '-9.18', 'ciUpperLimit': '8.35', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.98', 'groupDescription': 'Change from Baseline to Day 84', 'statisticalMethod': 'Mixed ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (D0) to D28 and D84', 'description': 'Instant skin elasticity was measured with Elastimeter® and defines the skin elasticity determined as a resistance against deformation caused by the Elastimeter® probe on the skin surface. 3 measurements were done on the same zone and the average value was calculated. The values were expressed in Newton/meter. Higher values of ISE indicate higher skin elasticity. A positive change from Baseline indicates increased skin elasticity. Values were obtained from a mixed ANOVA model. The data is presented for area treated with Juvéderm® VOLITE and non-treated area in the same participants.', 'unitOfMeasure': 'Newton/meter', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included any participant included in the study with at least a post-baseline value. Number analyzed is the number of participants with data available for analyses at the given timepoint.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Skin Thickness as Measured by Skin Scanner®', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Juvéderm® VOLITE Treated Zone', 'description': 'Participants received Juvéderm® VOLITE, intradermal injection on a zone of 8 cm x 4 cm (32 cm\\^2) of the volar left forearm on Day 0. The dose to be injected was decided by the investigator as per the Directions for Use. A maximum of 1 mL was injected on the zone treated.'}, {'id': 'OG001', 'title': 'Non-Treated Zone', 'description': 'The not-treated zone of the same arm in same the participant served as a control.'}], 'classes': [{'title': 'Change from Baseline to Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '56', 'spread': '72', 'groupId': 'OG000'}, {'value': '-14', 'spread': '35', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline to Day 84', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-85', 'spread': '74', 'groupId': 'OG000'}, {'value': '-3', 'spread': '36', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.4128', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '70', 'ciLowerLimit': '-142', 'ciUpperLimit': '282', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '77', 'groupDescription': 'Change from Baseline to Day 28', 'statisticalMethod': 'Mixed ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.'}, {'pValue': '0.3851', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-82', 'ciLowerLimit': '-355', 'ciUpperLimit': '191', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '79', 'groupDescription': 'Change from Baseline to Day 84', 'statisticalMethod': 'Mixed ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (D0) to D28 and D84', 'description': 'Skin thickness was measured as the average thickness of the epidermis and dermis (in mm) using SkinScanner®, a high frequency echograph. Values were obtained from a mixed ANOVA model. A positive change from Baseline indicates increased skin thickness. The data is presented for area treated with Juvéderm® VOLITE and non-treated area in the same participants.', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included any participant included in the study with at least a post-baseline value. Number analyzed is the number of participants with data available for analyses at the given timepoint.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Skin Density as Measured by Skin Scanner®', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Juvéderm® VOLITE Treated Zone', 'description': 'Participants received Juvéderm® VOLITE, intradermal injection on a zone of 8 cm x 4 cm (32 cm\\^2) of the volar left forearm on Day 0. The dose to be injected was decided by the investigator as per the Directions for Use. A maximum of 1 mL was injected on the zone treated.'}, {'id': 'OG001', 'title': 'Non-Treated Zone', 'description': 'The not-treated zone of the same arm in same the participant served as a control.'}], 'classes': [{'title': 'Change from Baseline to Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.69', 'spread': '2.82', 'groupId': 'OG000'}, {'value': '-1.83', 'spread': '2.31', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline to Day 84', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.56', 'spread': '2.65', 'groupId': 'OG000'}, {'value': '3.00', 'spread': '2.27', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0798', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.52', 'ciLowerLimit': '-0.89', 'ciUpperLimit': '13.93', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.44', 'groupDescription': 'Change from Baseline to Day 28', 'statisticalMethod': 'Mixed ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.'}, {'pValue': '0.1142', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.56', 'ciLowerLimit': '-1.55', 'ciUpperLimit': '12.67', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.27', 'groupDescription': 'Change from Baseline to Day 84', 'statisticalMethod': 'Mixed ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (D0) to D28 and D84', 'description': 'Skin density was measured as the percentage of echogenic surface using SkinScanner®, a high frequency echograph. Values were obtained from a mixed ANOVA model. A positive change from Baseline indicates increased skin density. The data is presented for area treated with Juvéderm® VOLITE and non-treated area in the same participants.', 'unitOfMeasure': 'percentage of echogenic surface', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included any participant included in the study with at least a post-baseline value. Number analyzed is the number of participants with data available for analyses at the given timepoint.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Skin Roughness as Measured by Vivosight OCT®', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Juvéderm® VOLITE Treated Zone', 'description': 'Participants received Juvéderm® VOLITE, intradermal injection on a zone of 8 cm x 4 cm (32 cm\\^2) of the volar left forearm on Day 0. The dose to be injected was decided by the investigator as per the Directions for Use. A maximum of 1 mL was injected on the zone treated.'}, {'id': 'OG001', 'title': 'Non-Treated Zone', 'description': 'The not-treated zone of the same arm in same the participant served as a control.'}], 'classes': [{'title': 'Ra: Change from Baseline to Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.94', 'spread': '0.64', 'groupId': 'OG000'}, {'value': '-1.90', 'spread': '0.63', 'groupId': 'OG001'}]}]}, {'title': 'Ra: Change from Baseline to Day 84', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.27', 'spread': '0.53', 'groupId': 'OG000'}, {'value': '-1.37', 'spread': '0.54', 'groupId': 'OG001'}]}]}, {'title': 'Rz: Change from Baseline to Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.95', 'spread': '3.59', 'groupId': 'OG000'}, {'value': '-9.85', 'spread': '3.53', 'groupId': 'OG001'}]}]}, {'title': 'Rz: Change from Baseline to Day 84', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.64', 'spread': '3.26', 'groupId': 'OG000'}, {'value': '-11.86', 'spread': '3.35', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.2592', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.96', 'ciLowerLimit': '-0.78', 'ciUpperLimit': '2.71', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.82', 'groupDescription': 'Ra: Change from Baseline to Day 28', 'statisticalMethod': 'Mixed ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.'}, {'pValue': '0.1341', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.09', 'ciLowerLimit': '-0.38', 'ciUpperLimit': '2.57', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.69', 'groupDescription': 'Ra: Change from Baseline to Day 84', 'statisticalMethod': 'Mixed ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.'}, {'pValue': '0.2138', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.91', 'ciLowerLimit': '-3.79', 'ciUpperLimit': '15.61', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.55', 'groupDescription': 'Rz: Change from Baseline to Day 28', 'statisticalMethod': 'Mixed ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.'}, {'pValue': '0.0700', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '8.22', 'ciLowerLimit': '-0.77', 'ciUpperLimit': '17.20', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.20', 'groupDescription': 'Rz: Change from Baseline to Day 84', 'statisticalMethod': 'Mixed ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (D0) to D28 and D84', 'description': 'Skin roughness was measured by Vivosight optical coherence tomography (OCT®) system which is used to obtain high resolution imaging of skin sub-structures and vascular networks. The skin roughness parameters from the images included Ra and Rz. Ra is a measure of the average length that is between peaks and valleys. Rz helps measure the vertical distance between the highest peak and the lowest valley. Values were obtained from a mixed ANOVA model. A negative change from Baseline indicates decreased skin roughness. The data is presented for area treated with Juvéderm® VOLITE and non-treated area in the same participants.', 'unitOfMeasure': 'µm', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included any participant included in the study with at least a post-baseline value. Number analyzed is the number of participants with data available for analyses at the given timepoint.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Epidermal Thickness as Measured by Vivosight OCT®', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Juvéderm® VOLITE Treated Zone', 'description': 'Participants received Juvéderm® VOLITE, intradermal injection on a zone of 8 cm x 4 cm (32 cm\\^2) of the volar left forearm on Day 0. The dose to be injected was decided by the investigator as per the Directions for Use. A maximum of 1 mL was injected on the zone treated.'}, {'id': 'OG001', 'title': 'Non-Treated Zone', 'description': 'The not-treated zone of the same arm in same the participant served as a control.'}], 'classes': [{'title': 'Change from Baseline to Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.79', 'spread': '2.80', 'groupId': 'OG000'}, {'value': '1.68', 'spread': '2.22', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline to Day 84', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.93', 'spread': '3.64', 'groupId': 'OG000'}, {'value': '-0.51', 'spread': '2.77', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.9608', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.11', 'ciLowerLimit': '-4.70', 'ciUpperLimit': '4.91', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.17', 'groupDescription': 'Change from Baseline to Day 28', 'statisticalMethod': 'Mixed ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.'}, {'pValue': '0.6192', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.42', 'ciLowerLimit': '-7.48', 'ciUpperLimit': '4.64', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.79', 'groupDescription': 'Change from Baseline to Day 84', 'statisticalMethod': 'Mixed ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (D0) to D28 and D84', 'description': 'Epidermal thickness is a skin density parameter measured by Vivosight OCT® system used to obtain high resolution imaging of skin sub-structures and vascular networks. Values were obtained from a mixed ANOVA model. A positive change from Baseline indicates increased epidermal thickness. The data is presented for area treated with Juvéderm® VOLITE and non-treated area in the same participants.', 'unitOfMeasure': 'µm', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included any participant included in the study with at least a post-baseline value. Number analyzed is the number of participants with data available for analyses at the given timepoint.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Optical Attenuation Coefficient (OAC) as Measured by Vivosight OCT®', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Juvéderm® VOLITE Treated Zone', 'description': 'Participants received Juvéderm® VOLITE, intradermal injection on a zone of 8 cm x 4 cm (32 cm\\^2) of the volar left forearm on Day 0. The dose to be injected was decided by the investigator as per the Directions for Use. A maximum of 1 mL was injected on the zone treated.'}, {'id': 'OG001', 'title': 'Non-Treated Zone', 'description': 'The not-treated zone of the same arm in same the participant served as a control.'}], 'classes': [{'title': 'Change from Baseline to Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.02', 'spread': '0.09', 'groupId': 'OG000'}, {'value': '0.04', 'spread': '0.08', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline to Day 84', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.07', 'spread': '0.07', 'groupId': 'OG000'}, {'value': '0.18', 'spread': '0.07', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.8322', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.02', 'ciLowerLimit': '-0.20', 'ciUpperLimit': '0.16', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.08', 'groupDescription': 'Change from Baseline to Day 28', 'statisticalMethod': 'Mixed ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.'}, {'pValue': '0.1334', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.11', 'ciLowerLimit': '-0.25', 'ciUpperLimit': '0.04', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.07', 'groupDescription': 'Change from Baseline to Day 84', 'statisticalMethod': 'Mixed ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (D0) to D28 and D84', 'description': 'OAC is a skin density parameter measured by Vivosight OCT® system used to obtain high resolution imaging of skin sub-structures and vascular networks. It analytically describes the reduction of OCT signal intensity with increasing depth-in-tissue. Values were obtained from a mixed ANOVA model. A positive change from Baseline indicates increased skin density. The data is presented for area treated with Juvéderm® VOLITE and non-treated area in the same participants.', 'unitOfMeasure': 'mm^-1', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included any participant included in the study with at least a post-baseline value. Number analyzed is the number of participants with data available for analyses at the given timepoint.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Plexus Depth as Measured by Vivosight OCT®', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Juvéderm® VOLITE Treated Zone', 'description': 'Participants received Juvéderm® VOLITE, intradermal injection on a zone of 8 cm x 4 cm (32 cm\\^2) of the volar left forearm on Day 0. The dose to be injected was decided by the investigator as per the Directions for Use. A maximum of 1 mL was injected on the zone treated.'}, {'id': 'OG001', 'title': 'Non-Treated Zone', 'description': 'The not-treated zone of the same arm in same the participant served as a control.'}], 'classes': [{'title': 'Change from Baseline to Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-11.54', 'spread': '4.89', 'groupId': 'OG000'}, {'value': '-6.45', 'spread': '6.52', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline to Day 84', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-13.81', 'spread': '5.07', 'groupId': 'OG000'}, {'value': '-20.55', 'spread': '6.84', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.5221', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-5.09', 'ciLowerLimit': '-21.56', 'ciUpperLimit': '11.38', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '7.78', 'groupDescription': 'Change from Baseline to Day 28', 'statisticalMethod': 'Mixed ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.'}, {'pValue': '0.4174', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.74', 'ciLowerLimit': '-10.55', 'ciUpperLimit': '24.03', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '8.07', 'groupDescription': 'Change from Baseline to Day 84', 'statisticalMethod': 'Mixed ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (D0) to D28 and D84', 'description': 'Plexus depth is a skin vascularity parameter and was measured by Vivosight OCT® system which is used to obtain high resolution imaging of skin sub-structures and vascular networks. Values were obtained from a mixed ANOVA model. A negative change from Baseline indicates decreased plexus depth. The data is presented for area treated with Juvéderm® VOLITE and non-treated area in the same participants.', 'unitOfMeasure': 'µm', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included any participant included in the study with at least a post-baseline value. Number analyzed is the number of participants with data available for analyses at the given timepoint.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Vessel Diameter as Measured by Vivosight OCT®', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Juvéderm® VOLITE Treated Zone', 'description': 'Participants received Juvéderm® VOLITE, intradermal injection on a zone of 8 cm x 4 cm (32 cm\\^2) of the volar left forearm on Day 0. The dose to be injected was decided by the investigator as per the Directions for Use. A maximum of 1 mL was injected on the zone treated.'}, {'id': 'OG001', 'title': 'Non-Treated Zone', 'description': 'The not-treated zone of the same arm in same the participant served as a control.'}], 'classes': [{'title': 'Change from Baseline to Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.59', 'spread': '2.42', 'groupId': 'OG000'}, {'value': '-0.18', 'spread': '2.62', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline to Day 84', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.66', 'spread': '2.35', 'groupId': 'OG000'}, {'value': '-6.33', 'spread': '2.63', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.3052', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.77', 'ciLowerLimit': '-2.90', 'ciUpperLimit': '8.44', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.58', 'groupDescription': 'Change from Baseline to Day 28', 'statisticalMethod': 'Mixed ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.'}, {'pValue': '0.0016', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '9.99', 'ciLowerLimit': '4.48', 'ciUpperLimit': '15.50', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.57', 'groupDescription': 'Change from Baseline to Day 84', 'statisticalMethod': 'Mixed ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (D0) to D28 and D84', 'description': 'Vessel diameter is a skin vascularity parameter and was measured by Vivosight OCT® system which is used to obtain high resolution imaging of skin sub-structures and vascular networks. Values were obtained from a mixed ANOVA model. A positive change from Baseline indicates increased vessel diameter. The data is presented for area treated with Juvéderm® VOLITE and non-treated area in the same participants.', 'unitOfMeasure': 'µm', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included any participant included in the study with at least a post-baseline value. Number analyzed is the number of participants with data available for analyses at the given timepoint.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Vessel Density as Measured by Vivosight OCT®', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Juvéderm® VOLITE Treated Zone', 'description': 'Participants received Juvéderm® VOLITE, intradermal injection on a zone of 8 cm x 4 cm (32 cm\\^2) of the volar left forearm on Day 0. The dose to be injected was decided by the investigator as per the Directions for Use. A maximum of 1 mL was injected on the zone treated.'}, {'id': 'OG001', 'title': 'Non-Treated Zone', 'description': 'The not-treated zone of the same arm in same the participant served as a control.'}], 'classes': [{'title': 'Change from Baseline to Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.47', 'spread': '0.50', 'groupId': 'OG000'}, {'value': '-0.23', 'spread': '0.47', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline to Day 84', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.19', 'spread': '0.31', 'groupId': 'OG000'}, {'value': '-0.36', 'spread': '0.30', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.1672', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.70', 'ciLowerLimit': '-0.33', 'ciUpperLimit': '1.73', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.48', 'groupDescription': 'Change from Baseline to Day 28', 'statisticalMethod': 'Mixed ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.'}, {'pValue': '0.0881', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.55', 'ciLowerLimit': '-0.10', 'ciUpperLimit': '1.21', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.29', 'groupDescription': 'Change from Baseline to Day 84', 'statisticalMethod': 'Mixed ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (D0) to D28 and D84', 'description': 'Vessel density is a skin vascularity parameter and was measured by Vivosight OCT® system which is used to obtain high resolution imaging of skin sub-structures and vascular networks. A positive change from Baseline indicates increased vessel density. Values were obtained from a mixed ANOVA model. The data is presented for area treated with Juvéderm® VOLITE and non-treated area in the same participants.', 'unitOfMeasure': 'dimensionless', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included any participant included in the study with at least a post-baseline value. Number analyzed is the number of participants with data available for analyses at the given timepoint.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in 300 μm Density as Measured by Vivosight OCT®', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Juvéderm® VOLITE Treated Zone', 'description': 'Participants received Juvéderm® VOLITE, intradermal injection on a zone of 8 cm x 4 cm (32 cm\\^2) of the volar left forearm on Day 0. The dose to be injected was decided by the investigator as per the Directions for Use. A maximum of 1 mL was injected on the zone treated.'}, {'id': 'OG001', 'title': 'Non-Treated Zone', 'description': 'The not-treated zone of the same arm in same the participant served as a control.'}], 'classes': [{'title': 'Change from Baseline to Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.75', 'spread': '0.26', 'groupId': 'OG000'}, {'value': '0.17', 'spread': '0.31', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline to Day 84', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.13', 'spread': '0.29', 'groupId': 'OG000'}, {'value': '0.33', 'spread': '0.34', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0577', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.57', 'ciLowerLimit': '-0.02', 'ciUpperLimit': '1.17', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.28', 'groupDescription': 'Change from Baseline to Day 28', 'statisticalMethod': 'Mixed ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.'}, {'pValue': '0.5224', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.20', 'ciLowerLimit': '-0.85', 'ciUpperLimit': '0.45', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.31', 'groupDescription': 'Change from Baseline to Day 84', 'statisticalMethod': 'Mixed ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (D0) to D28 and D84', 'description': '300 μm density is a skin vascularity parameter and was measured by Vivosight OCT® system which is used to obtain high resolution imaging of skin sub-structures and vascular networks. Values were obtained from a mixed ANOVA model. A positive change from Baseline indicates increased 300 μm density. The data is presented for area treated with Juvéderm® VOLITE and non-treated area in the same participants.', 'unitOfMeasure': 'dimensionless', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included any participant included in the study with at least a post-baseline value. Number analyzed is the number of participants with data available for analyses at the given timepoint.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Skin Brightness Index as Measured by Glossymeter®', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Juvéderm® VOLITE Treated Zone', 'description': 'Participants received Juvéderm® VOLITE, intradermal injection on a zone of 8 cm x 4 cm (32 cm\\^2) of the volar left forearm on Day 0. The dose to be injected was decided by the investigator as per the Directions for Use. A maximum of 1 mL was injected on the zone treated.'}, {'id': 'OG001', 'title': 'Non-Treated Zone', 'description': 'The not-treated zone of the same arm in same the participant served as a control.'}], 'classes': [{'title': 'Change from Baseline to Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.1', 'spread': '0.2', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '0.1', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline to Day 84', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.4', 'spread': '0.2', 'groupId': 'OG000'}, {'value': '0.2', 'spread': '0.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.2666', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.2', 'ciLowerLimit': '-0.6', 'ciUpperLimit': '0.2', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.2', 'groupDescription': 'Change from Baseline to Day 28', 'statisticalMethod': 'Mixed ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.'}, {'pValue': '0.4366', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.2', 'ciLowerLimit': '-0.3', 'ciUpperLimit': '0.7', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.2', 'groupDescription': 'Change from Baseline to Day 84', 'statisticalMethod': 'Mixed ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (D0) to D28 and D84', 'description': 'Skin brightness index was measured using Glossymeter®. 3 measurements were done on the same zone and the average value was calculated. Values were expressed in "Glossymeter Units". Values were obtained from a mixed ANOVA model. Higher glossymeter values indicate higher skin brightness. A positive change from Baseline indicates increased skin brightness. The data is presented for area treated with Juvéderm® VOLITE and non-treated area in the same participants.', 'unitOfMeasure': 'glossymeter unit', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included any participant included in the study with at least a post-baseline value. Number analyzed is the number of participants with data available for analyses at the given timepoint.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Skin Colour as Measured by Spectrophotometer®', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Juvéderm® VOLITE Treated Zone', 'description': 'Participants received Juvéderm® VOLITE, intradermal injection on a zone of 8 cm x 4 cm (32 cm\\^2) of the volar left forearm on Day 0. The dose to be injected was decided by the investigator as per the Directions for Use. A maximum of 1 mL was injected on the zone treated.'}, {'id': 'OG001', 'title': 'Non-Treated Zone', 'description': 'The not-treated zone of the same arm in same the participant served as a control.'}], 'classes': [{'title': 'a*: Change from Baseline to Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.3', 'spread': '0.2', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '0.2', 'groupId': 'OG001'}]}]}, {'title': 'a*: Change from Baseline to Day 84', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.8', 'spread': '0.3', 'groupId': 'OG000'}, {'value': '-0.7', 'spread': '0.2', 'groupId': 'OG001'}]}]}, {'title': 'b*: Change from Baseline to Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.3', 'spread': '0.3', 'groupId': 'OG000'}, {'value': '-0.2', 'spread': '0.2', 'groupId': 'OG001'}]}]}, {'title': 'b*: Change from Baseline to Day 84', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.4', 'spread': '0.4', 'groupId': 'OG000'}, {'value': '-1.1', 'spread': '0.4', 'groupId': 'OG001'}]}]}, {'title': 'L*: Change from Baseline to Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.4', 'spread': '0.3', 'groupId': 'OG000'}, {'value': '0.8', 'spread': '0.3', 'groupId': 'OG001'}]}]}, {'title': 'L*: Change from Baseline to Day 84', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.7', 'spread': '0.3', 'groupId': 'OG000'}, {'value': '1.1', 'spread': '0.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.4197', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.2', 'ciLowerLimit': '-0.6', 'ciUpperLimit': '0.3', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.2', 'groupDescription': 'a\\*: Change from Baseline to Day 28', 'statisticalMethod': 'Mixed ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.'}, {'pValue': '0.9140', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.0', 'ciLowerLimit': '-0.6', 'ciUpperLimit': '0.5', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.3', 'groupDescription': 'a\\*: Change from Baseline to Day 84', 'statisticalMethod': 'Mixed ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.'}, {'pValue': '0.7604', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.1', 'ciLowerLimit': '-0.6', 'ciUpperLimit': '0.4', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.2', 'groupDescription': 'b\\*: Change from Baseline to Day 28', 'statisticalMethod': 'Mixed ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.'}, {'pValue': '0.5936', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.2', 'ciLowerLimit': '-1.0', 'ciUpperLimit': '0.6', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.4', 'groupDescription': 'b\\*: Change from Baseline to Day 84', 'statisticalMethod': 'Mixed ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.'}, {'pValue': '0.0808', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.4', 'ciLowerLimit': '-0.9', 'ciUpperLimit': '0.1', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.2', 'groupDescription': 'L\\*: Change from Baseline to Day 28', 'statisticalMethod': 'Mixed ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.'}, {'pValue': '0.1633', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.4', 'ciLowerLimit': '-1.0', 'ciUpperLimit': '0.2', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.3', 'groupDescription': 'L\\*: Change from Baseline to Day 84', 'statisticalMethod': 'Mixed ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (D0) to D28 and D84', 'description': "Skin colour was measured by Spectrophotometer®. It converts colours perceived by man to a digital code composed of three parameters: L\\*: for clarity (from dark to light) a\\*: for the green-to-red spectrum b\\*: for the blue-to-yellow spectrum; a\\* and b\\* are chrominance parameters, L\\* is a luminance parameter. Higher values of a\\*, b\\*and L\\* indicates 'skin more red', 'skin more yellow' and 'skin clearer'. Values were obtained from a mixed ANOVA model and expressed in arbitrary units. The data is presented for area treated with Juvéderm® VOLITE and non-treated area in the same participants.", 'unitOfMeasure': 'arbitrary units', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included any participant included in the study with at least a post-baseline value. Number analyzed is the number of participants with data available for analyses at the given timepoint.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Individual Typological Angle (ITA°) as Measured by Spectrophotometer®', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Juvéderm® VOLITE Treated Zone', 'description': 'Participants received Juvéderm® VOLITE, intradermal injection on a zone of 8 cm x 4 cm (32 cm\\^2) of the volar left forearm on Day 0. The dose to be injected was decided by the investigator as per the Directions for Use. A maximum of 1 mL was injected on the zone treated.'}, {'id': 'OG001', 'title': 'Non-Treated Zone', 'description': 'The not-treated zone of the same arm in same the participant served as a control.'}], 'classes': [{'title': 'Change from Baseline to Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.4', 'spread': '0.6', 'groupId': 'OG000'}, {'value': '2.0', 'spread': '0.5', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline to Day 84', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.8', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '4.0', 'spread': '1.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.1977', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.6', 'ciLowerLimit': '-1.6', 'ciUpperLimit': '0.4', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.4', 'groupDescription': 'Change from Baseline to Day 28', 'statisticalMethod': 'Mixed ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.'}, {'pValue': '0.7535', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.3', 'ciLowerLimit': '-2.2', 'ciUpperLimit': '1.7', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.9', 'groupDescription': 'Change from Baseline to Day 84', 'statisticalMethod': 'Mixed ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (D0) to D28 and D84', 'description': "Individual typological angle (ITA°), defines the skin pigmentation degree of a participant with taking into account the skin clarity (L\\*) and the melanin parameter (b\\*). 3 measurements were done on the same zone and the average values were calculated. Values were obtained from a mixed ANOVA model and expressed in degree (°). Higher values of ITA° indicates 'skin less pigmented'. A positive change from Baseline indicates less pigmented skin. The data is presented for area treated with Juvéderm® VOLITE and non-treated area in the same participants.", 'unitOfMeasure': 'degree', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included any participant included in the study with at least a post-baseline value. Number analyzed is the number of participants with data available for analyses at the given timepoint.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Skin Melanin Index as Measured by Mexameter®', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Juvéderm® VOLITE Treated Zone', 'description': 'Participants received Juvéderm® VOLITE, intradermal injection on a zone of 8 cm x 4 cm (32 cm\\^2) of the volar left forearm on Day 0. The dose to be injected was decided by the investigator as per the Directions for Use. A maximum of 1 mL was injected on the zone treated.'}, {'id': 'OG001', 'title': 'Non-Treated Zone', 'description': 'The not-treated zone of the same arm in same the participant served as a control.'}], 'classes': [{'title': 'Change from Baseline to Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.78', 'spread': '4.66', 'groupId': 'OG000'}, {'value': '-8.13', 'spread': '3.34', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline to Day 84', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.53', 'spread': '7.44', 'groupId': 'OG000'}, {'value': '-19.79', 'spread': '5.47', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.2905', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.35', 'ciLowerLimit': '-4.16', 'ciUpperLimit': '12.85', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.95', 'groupDescription': 'Change from Baseline to Day 28', 'statisticalMethod': 'Mixed ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.'}, {'pValue': '0.0241', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '17.27', 'ciLowerLimit': '2.84', 'ciUpperLimit': '31.69', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '6.37', 'groupDescription': 'Change from Baseline to Day 84', 'statisticalMethod': 'Mixed ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (D0) to D28 and D84', 'description': 'Melanin index measured with Mexameter® defines the skin pigmentation related to melanin content in the skin. Measurements are performed by the application of a probe to the skin surface. The probe has a 5 mm aperture that emits radiations. These radiations are reflected by the skin and captured back by the same probe. The results are expressed as an index value for each parameter in arbitrary units from 0 to 999. 3 measurements were done on the same zone and the average value was calculated. Values were obtained from a mixed ANOVA model. A negative change from Baseline indicates less pigmented skin. The data is presented for area treated with Juvéderm® VOLITE and non-treated area in the same participants.', 'unitOfMeasure': 'arbitrary units', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included any participant included in the study with at least a post-baseline value. Number analyzed is the number of participants with data available for analyses at the given timepoint.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With at Least One Treatment-emergent Adverse Event (AE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Juvéderm® VOLITE Treated Zone', 'description': 'Participants received Juvéderm® VOLITE, intradermal injection on a zone of 8 cm x 4 cm (32 cm\\^2) of the volar left forearm on Day 0. The dose to be injected was decided by the investigator as per the Directions for Use. A maximum of 1 mL was injected on the zone treated.'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'First dose of study treatment to end of the study (Up to 9 months)', 'description': 'An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. A treatment-emergent AE is an AE that occurs or worsens after a participant receives study drug.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population included any participant having used the tested device.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Injection Site Reactions (ISR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Juvéderm® VOLITE Treated Zone', 'description': 'Participants received Juvéderm® VOLITE, intradermal injection on a zone of 8 cm x 4 cm (32 cm\\^2) of the volar left forearm on Day 0. The dose to be injected was decided by the investigator as per the Directions for Use. A maximum of 1 mL was injected on the zone treated.'}], 'classes': [{'title': 'Redness/Erythema: Mild', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}, {'title': 'Pain/Tenderness: None', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Pain/Tenderness: Mild', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'Induration: None', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}, {'title': 'Swelling/Oedema: None', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Swelling/Oedema: Mild', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'Lumps/Bumps: None', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Lumps/Bumps: Mild', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': 'Bruising/Hematoma: None', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Bruising/Hematoma: Mild', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'Bruising/Hematoma: Moderate', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Itching: None', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}, {'title': 'Discoloration/Pigmentation: None', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 0', 'description': 'ISRs are reactions that occur after injection of the study drug. The following ISRs: Redness/Erythema, Pain/Tenderness, Induration, Swelling/Oedema, Lumps/Bumps, Bruising/Hematoma, Itching, Discoloration/Pigmentation were reported as None, Mild, Moderate or Severe. Only those categories reported for at least 1 participant are reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population included any participant having used the tested device.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Juvéderm® VOLITE Treated Zone', 'description': 'Participants received Juvéderm® VOLITE, intradermal injection on a zone of 8 cm x 4 cm (32 cm\\^2) of the volar left forearm on Day 0. The dose to be injected was decided by the investigator as per the Directions for Use. A maximum of 1 mL was injected on the zone treated.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Consent withdrawal', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Juvéderm® VOLITE Treated Zone', 'description': 'Participants received Juvéderm® VOLITE, intradermal injection on a zone of 8 cm x 4 cm (32 cm\\^2) of the volar left forearm on Day 0. The dose to be injected was decided by the investigator as per the Directions for Use. A maximum of 1 mL was injected on the zone treated.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '40.82', 'spread': '6.10', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Skin Hydration (MoistureMeterD® XS Probe)', 'classes': [{'title': 'Juvéderm® VOLITE Treated Zone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '32.6', 'spread': '4.3', 'groupId': 'BG000'}]}]}, {'title': 'Non-Treated Zone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '35.9', 'spread': '5.3', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Skin hydration was measured using MoistureMeterD® XS (for epidermis and dermis), a non-invasive probe which measures the dielectric constant of the skin at a depth of 0.5 mm. 5 measurements were done on the same zone and the average value was calculated, expressed as tissue dielectric constant (TDC). The TDC is directly proportional to the amount of water in the tissue.', 'unitOfMeasure': 'tissue dielectric constant', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Skin Hydration (MoistureMeterD® S Probe)', 'classes': [{'title': 'Juvéderm® VOLITE Treated Zone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '35.9', 'spread': '5.3', 'groupId': 'BG000'}]}]}, {'title': 'Non-Treated Zone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '30.6', 'spread': '2.6', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Skin hydration was measured using MoistureMeter D® S15 (for epidermis and dermis), a non-invasive probe which measures the dielectric constant of the skin at a depth of 1.5 mm. 5 measurements were done on the same zone and the average value was calculated, expressed as TDC. The TDC is directly proportional to the amount of water in the tissue.', 'unitOfMeasure': 'tissue dielectric constant', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Skin Hydration (Corneometer®)', 'classes': [{'title': 'Juvéderm® VOLITE Treated Zone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '29.5', 'spread': '5.5', 'groupId': 'BG000'}]}]}, {'title': 'Non-Treated Zone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '29.3', 'spread': '5.5', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Corneometer® measures the hydration level of the superficial skin surface (epidermis). It uses fringing field capacitance sensors to measure the dielectric constant of the skin. The dielectric constant of skin will change with water content. This allows for any changes in skin hydration to be measured by the precision measuring capacitor. These changes in water content of the stratum corneum are converted into arbitrary units of hydration. 5 measurements were done on the same zone and average value was calculated.', 'unitOfMeasure': 'arbitrary units of hydration', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Skin Elasticity Parameters (Cutometer ®)', 'classes': [{'title': 'Uf: Juvéderm® VOLITE Treated Zone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '0.989', 'spread': '0.109', 'groupId': 'BG000'}]}]}, {'title': 'Uf: Non-Treated Zone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '1.041', 'spread': '0.127', 'groupId': 'BG000'}]}]}, {'title': 'Ue: Juvéderm® VOLITE Treated Zone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '0.816', 'spread': '0.100', 'groupId': 'BG000'}]}]}, {'title': 'Ue: Non-Treated Zone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '0.864', 'spread': '0.115', 'groupId': 'BG000'}]}]}, {'title': 'Ur: Juvéderm® VOLITE Treated Zone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '0.660', 'spread': '0.131', 'groupId': 'BG000'}]}]}, {'title': 'Ur: Non-Treated Zone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '0.777', 'spread': '0.138', 'groupId': 'BG000'}]}]}, {'title': 'Ua: Juvéderm® VOLITE Treated Zone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '0.844', 'spread': '0.125', 'groupId': 'BG000'}]}]}, {'title': 'Ua: Non-Treated Zone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '0.916', 'spread': '0.131', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Skin elasticity was measured by a Cutometer ® which uses an in vivo non-invasive method to evaluate biological extensibility and elasticity variations. The various parameters analysed were Uf: final deformation (firmness), Ue: immediate extensibility, Ur: immediate retraction (tonicity), Ua: total recovery of the initial state. 2 measurements were done on the same zone and the average value was calculated.', 'unitOfMeasure': 'millimeters (mm)', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Relative Parameters of Skin Elasticity (Cutometer ®)', 'classes': [{'title': 'Elastic Recovery (Q1): Juvéderm® VOLITE Treated Zone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '0.781', 'spread': '0.052', 'groupId': 'BG000'}]}]}, {'title': 'Elastic Recovery (Q1): Non-Treated Zone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '0.825', 'spread': '0.046', 'groupId': 'BG000'}]}]}, {'title': 'Viscous Recovery (Q2): Juvéderm® VOLITE Treated Zone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '0.630', 'spread': '0.083', 'groupId': 'BG000'}]}]}, {'title': 'Viscous Recovery (Q2): Non-Treated Zone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '0.716', 'spread': '0.073', 'groupId': 'BG000'}]}]}, {'title': 'Viscoelastic Recovery (Q3): Juvéderm® VOLITE Treated Zone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '0.151', 'spread': '0.034', 'groupId': 'BG000'}]}]}, {'title': 'Viscoelastic Recovery (Q3): Non-Treated Zone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '0.109', 'spread': '0.028', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'The parameters evaluated were: Elastic Recovery (Q1)=elastic recovery area (QE)/maximum recovery area (QO), Viscous Recovery (Q2)=viscous recovery area (QR)/maximum recovery area (QO) and Viscoelastic Recovery (Q3)= (QE+QR)/QO. 2 measurements were done on the same zone and the average value was calculated.', 'unitOfMeasure': 'dimensionless', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Skin Elasticity', 'classes': [{'title': 'Juvéderm® VOLITE Treated Zone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '40.91', 'spread': '10.27', 'groupId': 'BG000'}]}]}, {'title': 'Non-Treated Zone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '38.55', 'spread': '11.49', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Instant skin elasticity was measured with Elastimeter® and defines the skin elasticity determined as a resistance against deformation caused by the Elastimeter® probe on the skin surface. 3 measurements were done on the same zone and the average value was calculated. The values were expressed in Newton/meter.', 'unitOfMeasure': 'Newton/meter', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Skin Thickness (Skin Scanner®)', 'classes': [{'title': 'Juvéderm® VOLITE Treated Zone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '1246', 'spread': '160', 'groupId': 'BG000'}]}]}, {'title': 'Non-Treated Zone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '1064', 'spread': '121', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Skin thickness was measured as the average thickness of the epidermis and dermis (in mm) using SkinScanner®, a high frequency echograph.', 'unitOfMeasure': 'mm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Skin Density (Skin Scanner®)', 'classes': [{'title': 'Juvéderm® VOLITE Treated Zone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '33.63', 'spread': '5.29', 'groupId': 'BG000'}]}]}, {'title': 'Non-Treated Zone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '44.05', 'spread': '7.05', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Skin density was measured as the percentage of echogenic surface using SkinScanner®, a high frequency echograph.', 'unitOfMeasure': 'percentage of echogenic surface', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Skin Roughness (Vivosight OCT®)', 'classes': [{'title': 'Ra: Juvéderm® VOLITE Treated Zone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '13.81', 'spread': '2.99', 'groupId': 'BG000'}]}]}, {'title': 'Ra: Non-Treated Zone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '18.17', 'spread': '2.16', 'groupId': 'BG000'}]}]}, {'title': 'Rz: Juvéderm® VOLITE Treated Zone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '89.50', 'spread': '16.63', 'groupId': 'BG000'}]}]}, {'title': 'Rz: Non-Treated Zone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '111.73', 'spread': '10.63', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Skin roughness was measured by Vivosight optical coherence tomography (OCT®) system which is used to obtain high resolution imaging of skin sub-structures and vascular networks. The skin roughness parameters from the images included Ra and Rz. Ra is a measure of the average length that is between peaks and valleys. Rz helps measure the vertical distance between the highest peak and the lowest valley.', 'unitOfMeasure': 'micrometer (µm)', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Epidermal Thickness (Vivosight OCT®)', 'classes': [{'title': 'Juvéderm® VOLITE Treated Zone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '92.64', 'spread': '14.93', 'groupId': 'BG000'}]}]}, {'title': 'Non-Treated Zone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '94.58', 'spread': '8.70', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Epidermal thickness is a skin density parameter measured by Vivosight OCT® system used to obtain high resolution imaging of skin sub-structures and vascular networks.', 'unitOfMeasure': 'µm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Optical Attenuation Coefficient (OAC) (Vivosight OCT®)', 'classes': [{'title': 'Juvéderm® VOLITE Treated Zone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '2.61', 'spread': '0.27', 'groupId': 'BG000'}]}]}, {'title': 'Non-Treated Zone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '2.71', 'spread': '0.21', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'OAC is a skin density parameter measured by Vivosight OCT® system used to obtain high resolution imaging of skin sub-structures and vascular networks. It analytically describes the reduction of OCT signal intensity with increasing depth-in-tissue.', 'unitOfMeasure': 'per mm (mm^-1)', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Plexus Depth (Vivosight OCT®)', 'classes': [{'title': 'Juvéderm® VOLITE Treated Zone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '332.59', 'spread': '13.90', 'groupId': 'BG000'}]}]}, {'title': 'Non-Treated Zone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '319.67', 'spread': '17.84', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Plexus depth is a skin vascularity parameter and was measured by Vivosight OCT® system which is used to obtain high resolution imaging of skin sub-structures and vascular networks.', 'unitOfMeasure': 'µm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Vessel Diameter (Vivosight OCT®)', 'classes': [{'title': 'Juvéderm® VOLITE Treated Zone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '44.13', 'spread': '8.12', 'groupId': 'BG000'}]}]}, {'title': 'Non-Treated Zone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '46.64', 'spread': '8.60', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Vessel diameter is a skin vascularity parameter and was measured by Vivosight OCT® system which is used to obtain high resolution imaging of skin sub-structures and vascular networks.', 'unitOfMeasure': 'µm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Vessel Density', 'classes': [{'title': 'Juvéderm® VOLITE Treated Zone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '1.98', 'spread': '0.98', 'groupId': 'BG000'}]}]}, {'title': 'Non-Treated Zone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '2.24', 'spread': '1.05', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Vessel density is a skin vascularity parameter and was measured by Vivosight OCT® system which is used to obtain high resolution imaging of skin sub-structures and vascular networks.', 'unitOfMeasure': 'dimensionless', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': '300 μm Density', 'classes': [{'title': 'Juvéderm® VOLITE Treated Zone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '2.61', 'spread': '0.62', 'groupId': 'BG000'}]}]}, {'title': 'Non-Treated Zone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '2.84', 'spread': '0.70', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': '300 μm density is a skin vascularity parameter and was measured by Vivosight OCT® system which is used to obtain high resolution imaging of skin sub-structures and vascular networks.', 'unitOfMeasure': 'dimensionless', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Skin Brightness Index', 'classes': [{'title': 'Juvéderm® VOLITE Treated Zone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '6.3', 'spread': '1.1', 'groupId': 'BG000'}]}]}, {'title': 'Non-Treated Zone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '5.7', 'spread': '0.8', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Skin brightness index was measured using Glossymeter®. 3 measurements were done on the same zone and the average value was calculated. Values were expressed in "Glossymeter Units".', 'unitOfMeasure': 'glossymeter units', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Skin Colour (Spectrophotometer®)', 'classes': [{'title': 'a*: Juvéderm® VOLITE Treated Zone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '6.3', 'spread': '2.0', 'groupId': 'BG000'}]}]}, {'title': 'a*: Non-Treated Zone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '7.0', 'spread': '1.5', 'groupId': 'BG000'}]}]}, {'title': 'b*: Juvéderm® VOLITE Treated Zone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '17.2', 'spread': '2.7', 'groupId': 'BG000'}]}]}, {'title': 'b*: Non-Treated Zone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '17.8', 'spread': '2.3', 'groupId': 'BG000'}]}]}, {'title': 'L*: Juvéderm® VOLITE Treated Zone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '64.7', 'spread': '2.8', 'groupId': 'BG000'}]}]}, {'title': 'L*: Non-Treated Zone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '64.1', 'spread': '2.5', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Skin colour was measured by Spectrophotometer®. It converts colours perceived by man to a digital code composed of three parameters: L\\*: for clarity (from dark to light) a\\*: for the green-to-red spectrum b\\*: for the blue-to-yellow spectrum; a\\* and b\\* are chrominance parameters, L\\* is a luminance parameter.', 'unitOfMeasure': 'arbitrary units', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Individual Typological Angle (ITA°) (Spectrophotometer®)', 'classes': [{'title': 'Juvéderm® VOLITE Treated Zone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '40.5', 'spread': '9.3', 'groupId': 'BG000'}]}]}, {'title': 'Non-Treated Zone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '38.4', 'spread': '8.1', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Individual typological angle (ITA°), defines the skin pigmentation degree of a participant with taking into account the skin clarity (L\\*) and the melanin parameter (b\\*). 3 measurements were done on the same zone and the average values were calculated. Values are expressed in degree (°).', 'unitOfMeasure': 'degree', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Skin Melanin Index (Mexameter®)', 'classes': [{'title': 'Juvéderm® VOLITE Treated Zone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '150.03', 'spread': '38.45', 'groupId': 'BG000'}]}]}, {'title': 'Non-Treated Zone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '181.40', 'spread': '32.49', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Melanin index measured with Mexameter® defines the skin pigmentation related to melanin content in the skin. Measurements are performed by the application of a probe to the skin surface. The probe has a 5 mm aperture that emits radiations. These radiations are reflected by the skin and captured back by the same probe. The results are expressed as an index value in arbitrary units from 0 to 999. 3 measurements were done on the same zone and the average value was calculated.', 'unitOfMeasure': 'arbitrary units', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Full Analysis Set included any participant included in the study with at least a post-baseline value.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-08-21', 'size': 10460895, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-07-29T19:52', 'hasProtocol': True}, {'date': '2020-01-16', 'size': 338534, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-07-29T19:52', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 11}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-10-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2020-07-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-07-29', 'studyFirstSubmitDate': '2019-12-18', 'resultsFirstSubmitDate': '2021-07-29', 'studyFirstSubmitQcDate': '2019-12-18', 'lastUpdatePostDateStruct': {'date': '2021-08-26', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-07-29', 'studyFirstPostDateStruct': {'date': '2019-12-20', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-08-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-07-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Skin Hydration as Measured by MoistureMeterD® 0.5 mm', 'timeFrame': 'Baseline [Day 0 (D0)] to Days 28 (D28) and 84 (D84)', 'description': 'Skin hydration was measured using MoistureMeterD® XS (for epidermis and dermis), a non-invasive probe which measures the dielectric constant of the skin at a depth of 0.5 mm. 5 measurements were done on the same zone and the average value was calculated, expressed as tissue dielectric constant (TDC). The TDC is directly proportional to the amount of water in the tissue. A positive change from Baseline indicates better skin hydration. Values were obtained from a mixed analysis of variance (ANOVA) model. The data is presented for area treated with Juvéderm® VOLITE and non-treated area in the same participants.'}, {'measure': 'Change From Baseline in Skin Hydration as Measured by MoistureMeter D® 1.5 mm', 'timeFrame': 'Baseline (D0) to D28 and D84', 'description': 'Skin hydration was measured using MoistureMeter D® S15 (for epidermis and dermis), a non-invasive probe which measures the dielectric constant of the skin at a depth of 1.5 mm. 5 measurements were done on the same zone and the average value was calculated, expressed as TDC. The TDC is directly proportional to the amount of water in the tissue. A positive change from Baseline indicates better skin hydration. Values were obtained from a mixed ANOVA model. The data is presented for area treated with Juvéderm® VOLITE and non-treated area in the same participants.'}, {'measure': 'Change From Baseline in Skin Hydration as Measured by Corneometer®', 'timeFrame': 'Baseline (D0) to D28 and D84', 'description': 'Corneometer® measures the hydration level of the superficial skin surface (epidermis). The measurement is based on capacitance measurement of a dielectric medium in this case skin. It uses fringing field capacitance sensors to measure the dielectric constant of the skin. The dielectric constant of skin will change with water content. This allows for any changes in skin hydration to be measured by the precision measuring capacitor. These changes in water content of the stratum corneum are converted into arbitrary units of hydration. 5 measurements were done on the same zone and average value was calculated. Values were obtained from a mixed ANOVA model and expressed in arbitrary units. A positive change from Baseline indicates better skin hydration rate. The data is presented for area treated with Juvéderm® VOLITE and non-treated area in the same participants.'}, {'measure': 'Change From Baseline in Skin Elasticity Parameters: Uf: Final Deformation (Firmness), Ue: Immediate Extensibility, Ur: Immediate Retraction (Tonicity), Ua: Total Recovery of the Initial State as Measured by Cutometer ®', 'timeFrame': 'Baseline (D0) to D28 and D84', 'description': 'Skin elasticity was measured by a Cutometer ® which uses an in vivo non-invasive method to evaluate biological extensibility and elasticity variations. The various parameters analysed were Uf: final deformation (firmness), Ue: immediate extensibility, Ur: immediate retraction (tonicity), Ua: total recovery of the initial state. 2 measurements were done on the same zone and the average value was calculated. Values were obtained from a mixed ANOVA model. A Negative change from Baseline indicates firmer skin. The data is presented for area treated with Juvéderm® VOLITE and non-treated area in the same participants.'}, {'measure': 'Change From Baseline in Relative Parameters of Skin Elasticity: Q1, Q2, Q3 as Measured by Cutometer ®', 'timeFrame': 'Baseline (D0) to D28 and D84', 'description': 'The parameters evaluated were: Elastic Recovery (Q1)=elastic recovery area (QE)/maximum recovery area (QO), Viscous Recovery (Q2)=viscous recovery area (QR)/maximum recovery area (QO) and Viscoelastic Recovery (Q3)= (QE+QR)/QO. 2 measurements were done on the same zone and the average value was calculated. Values were obtained from a mixed ANOVA model. A negative change from Baseline in Q1 and Q2 indicates decreased skin elasticity. A positive change from Baseline in Q3 indicates decreased skin elasticity. The data is presented for area treated with Juvéderm® VOLITE and non-treated area in the same participants.'}, {'measure': 'Number of Participants With at Least One Treatment-emergent Adverse Event (AE)', 'timeFrame': 'First dose of study treatment to end of the study (Up to 9 months)', 'description': 'An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. A treatment-emergent AE is an AE that occurs or worsens after a participant receives study drug.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Skin Elasticity as Measured by Elastimeter®', 'timeFrame': 'Baseline (D0) to D28 and D84', 'description': 'Instant skin elasticity was measured with Elastimeter® and defines the skin elasticity determined as a resistance against deformation caused by the Elastimeter® probe on the skin surface. 3 measurements were done on the same zone and the average value was calculated. The values were expressed in Newton/meter. Higher values of ISE indicate higher skin elasticity. A positive change from Baseline indicates increased skin elasticity. Values were obtained from a mixed ANOVA model. The data is presented for area treated with Juvéderm® VOLITE and non-treated area in the same participants.'}, {'measure': 'Change From Baseline in Skin Thickness as Measured by Skin Scanner®', 'timeFrame': 'Baseline (D0) to D28 and D84', 'description': 'Skin thickness was measured as the average thickness of the epidermis and dermis (in mm) using SkinScanner®, a high frequency echograph. Values were obtained from a mixed ANOVA model. A positive change from Baseline indicates increased skin thickness. The data is presented for area treated with Juvéderm® VOLITE and non-treated area in the same participants.'}, {'measure': 'Change From Baseline in Skin Density as Measured by Skin Scanner®', 'timeFrame': 'Baseline (D0) to D28 and D84', 'description': 'Skin density was measured as the percentage of echogenic surface using SkinScanner®, a high frequency echograph. Values were obtained from a mixed ANOVA model. A positive change from Baseline indicates increased skin density. The data is presented for area treated with Juvéderm® VOLITE and non-treated area in the same participants.'}, {'measure': 'Change From Baseline in Skin Roughness as Measured by Vivosight OCT®', 'timeFrame': 'Baseline (D0) to D28 and D84', 'description': 'Skin roughness was measured by Vivosight optical coherence tomography (OCT®) system which is used to obtain high resolution imaging of skin sub-structures and vascular networks. The skin roughness parameters from the images included Ra and Rz. Ra is a measure of the average length that is between peaks and valleys. Rz helps measure the vertical distance between the highest peak and the lowest valley. Values were obtained from a mixed ANOVA model. A negative change from Baseline indicates decreased skin roughness. The data is presented for area treated with Juvéderm® VOLITE and non-treated area in the same participants.'}, {'measure': 'Change From Baseline in Epidermal Thickness as Measured by Vivosight OCT®', 'timeFrame': 'Baseline (D0) to D28 and D84', 'description': 'Epidermal thickness is a skin density parameter measured by Vivosight OCT® system used to obtain high resolution imaging of skin sub-structures and vascular networks. Values were obtained from a mixed ANOVA model. A positive change from Baseline indicates increased epidermal thickness. The data is presented for area treated with Juvéderm® VOLITE and non-treated area in the same participants.'}, {'measure': 'Change From Baseline in Optical Attenuation Coefficient (OAC) as Measured by Vivosight OCT®', 'timeFrame': 'Baseline (D0) to D28 and D84', 'description': 'OAC is a skin density parameter measured by Vivosight OCT® system used to obtain high resolution imaging of skin sub-structures and vascular networks. It analytically describes the reduction of OCT signal intensity with increasing depth-in-tissue. Values were obtained from a mixed ANOVA model. A positive change from Baseline indicates increased skin density. The data is presented for area treated with Juvéderm® VOLITE and non-treated area in the same participants.'}, {'measure': 'Change From Baseline in Plexus Depth as Measured by Vivosight OCT®', 'timeFrame': 'Baseline (D0) to D28 and D84', 'description': 'Plexus depth is a skin vascularity parameter and was measured by Vivosight OCT® system which is used to obtain high resolution imaging of skin sub-structures and vascular networks. Values were obtained from a mixed ANOVA model. A negative change from Baseline indicates decreased plexus depth. The data is presented for area treated with Juvéderm® VOLITE and non-treated area in the same participants.'}, {'measure': 'Change From Baseline in Vessel Diameter as Measured by Vivosight OCT®', 'timeFrame': 'Baseline (D0) to D28 and D84', 'description': 'Vessel diameter is a skin vascularity parameter and was measured by Vivosight OCT® system which is used to obtain high resolution imaging of skin sub-structures and vascular networks. Values were obtained from a mixed ANOVA model. A positive change from Baseline indicates increased vessel diameter. The data is presented for area treated with Juvéderm® VOLITE and non-treated area in the same participants.'}, {'measure': 'Change From Baseline in Vessel Density as Measured by Vivosight OCT®', 'timeFrame': 'Baseline (D0) to D28 and D84', 'description': 'Vessel density is a skin vascularity parameter and was measured by Vivosight OCT® system which is used to obtain high resolution imaging of skin sub-structures and vascular networks. A positive change from Baseline indicates increased vessel density. Values were obtained from a mixed ANOVA model. The data is presented for area treated with Juvéderm® VOLITE and non-treated area in the same participants.'}, {'measure': 'Change From Baseline in 300 μm Density as Measured by Vivosight OCT®', 'timeFrame': 'Baseline (D0) to D28 and D84', 'description': '300 μm density is a skin vascularity parameter and was measured by Vivosight OCT® system which is used to obtain high resolution imaging of skin sub-structures and vascular networks. Values were obtained from a mixed ANOVA model. A positive change from Baseline indicates increased 300 μm density. The data is presented for area treated with Juvéderm® VOLITE and non-treated area in the same participants.'}, {'measure': 'Change From Baseline in Skin Brightness Index as Measured by Glossymeter®', 'timeFrame': 'Baseline (D0) to D28 and D84', 'description': 'Skin brightness index was measured using Glossymeter®. 3 measurements were done on the same zone and the average value was calculated. Values were expressed in "Glossymeter Units". Values were obtained from a mixed ANOVA model. Higher glossymeter values indicate higher skin brightness. A positive change from Baseline indicates increased skin brightness. The data is presented for area treated with Juvéderm® VOLITE and non-treated area in the same participants.'}, {'measure': 'Change From Baseline in Skin Colour as Measured by Spectrophotometer®', 'timeFrame': 'Baseline (D0) to D28 and D84', 'description': "Skin colour was measured by Spectrophotometer®. It converts colours perceived by man to a digital code composed of three parameters: L\\*: for clarity (from dark to light) a\\*: for the green-to-red spectrum b\\*: for the blue-to-yellow spectrum; a\\* and b\\* are chrominance parameters, L\\* is a luminance parameter. Higher values of a\\*, b\\*and L\\* indicates 'skin more red', 'skin more yellow' and 'skin clearer'. Values were obtained from a mixed ANOVA model and expressed in arbitrary units. The data is presented for area treated with Juvéderm® VOLITE and non-treated area in the same participants."}, {'measure': 'Change From Baseline in Individual Typological Angle (ITA°) as Measured by Spectrophotometer®', 'timeFrame': 'Baseline (D0) to D28 and D84', 'description': "Individual typological angle (ITA°), defines the skin pigmentation degree of a participant with taking into account the skin clarity (L\\*) and the melanin parameter (b\\*). 3 measurements were done on the same zone and the average values were calculated. Values were obtained from a mixed ANOVA model and expressed in degree (°). Higher values of ITA° indicates 'skin less pigmented'. A positive change from Baseline indicates less pigmented skin. The data is presented for area treated with Juvéderm® VOLITE and non-treated area in the same participants."}, {'measure': 'Change From Baseline in Skin Melanin Index as Measured by Mexameter®', 'timeFrame': 'Baseline (D0) to D28 and D84', 'description': 'Melanin index measured with Mexameter® defines the skin pigmentation related to melanin content in the skin. Measurements are performed by the application of a probe to the skin surface. The probe has a 5 mm aperture that emits radiations. These radiations are reflected by the skin and captured back by the same probe. The results are expressed as an index value for each parameter in arbitrary units from 0 to 999. 3 measurements were done on the same zone and the average value was calculated. Values were obtained from a mixed ANOVA model. A negative change from Baseline indicates less pigmented skin. The data is presented for area treated with Juvéderm® VOLITE and non-treated area in the same participants.'}, {'measure': 'Number of Participants With Injection Site Reactions (ISR)', 'timeFrame': 'Day 0', 'description': 'ISRs are reactions that occur after injection of the study drug. The following ISRs: Redness/Erythema, Pain/Tenderness, Induration, Swelling/Oedema, Lumps/Bumps, Bruising/Hematoma, Itching, Discoloration/Pigmentation were reported as None, Mild, Moderate or Severe. Only those categories reported for at least 1 participant are reported.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy Adults', 'Skin Enhancement']}, 'descriptionModule': {'briefSummary': 'To evaluate the impact on skin quality attributes, including physical measurements and gene and protein expression (histological and genomic analysis), following administration of Juvéderm® VOLITE in the volar forearms of healthy volunteers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '30 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy participants\n* Participants with Fitzpatrick skin type II or III\n* Participant willing to receive Juvéderm® VOLITE in the forearms and agrees to complete all study required procedures, including having 6 cutaneous punch biopsies taken in the forearms and blood drawn (Human immunodeficiency virus \\[HIV\\], B and C hepatitis analysis at screening)\n* Written informed consent and data privacy consent obtained\n\nExclusion Criteria:\n\n* Pregnant or nursing woman or planning a pregnancy during the study\n* Participant participating to another research on human beings or being in an exclusion period for a previous study\n* Intensive exposure to sunlight or ultraviolet (UV)-rays within the previous month and foreseen during the study\n* Participant having other resorbable filling product injections, a laser treatment, an ultrasound-based treatment, radiation treatment, a dermabrasion, a surgery, a deep chemical peeling or other ablative procedure on the studied zones within the past 12 months prior to study start\n* Participant with subcutaneous retaining structure on the studied zones (meshing, threads, gold strand)\n* Participant having received injections of permanent or semi-permanent filling products in the studied zones\n* Participant under anti-coagulant treatment or treatment liable to interfere with the healing process or hemostasis, during the previous month and during the study\n* Participant receiving or is planning to receive anti-inflammatory drugs (oral/injectable corticosteroids or Nonsteroidal anti-inflammatory drugs (NSAIDs), e.g., aspirin, ibuprofen), or other substances known to increase coagulation time (herbal supplements with garlic or ginkgo biloba, etc) for 10 days prior to study treatment and 3 days after\n* Participant under immunosuppressive therapy'}, 'identificationModule': {'nctId': 'NCT04206293', 'briefTitle': 'A Study to Evaluate The Impact on Skin Quality Attributes by Juvederm® Volite Injection on Healthy Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Allergan'}, 'officialTitle': 'Prospective, Open-Label Study, to Evaluate The Impact on Skin Quality Attributes by Juvederm® Volite Injection on Healthy Volunteers', 'orgStudyIdInfo': {'id': 'CMO-MA-FAS-0617'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Juvéderm® VOLITE', 'description': 'Participants received Juvéderm® VOLITE, intradermal injection on a zone of 8 centimeter (cm) x 4 cm (32 cm\\^2) of the volar left forearm on Day 0. The dose to be injected was decided by the investigator as per the Directions for Use. A maximum of 1 milliliter (mL) was injected on the zone treated.', 'interventionNames': ['Device: Juvederm® VOLITE']}], 'interventions': [{'name': 'Juvederm® VOLITE', 'type': 'DEVICE', 'description': '1 mL of Juvéderm® VOLITE contains hyaluronic acid gel 12.0 milligram (mg), lidocaine hydrochloride 3.0 mg in a phosphate buffer pH 7.2 q.s. 1 mL (or gram).', 'armGroupLabels': ['Juvéderm® VOLITE']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80288', 'city': 'Gdansk', 'country': 'Poland', 'facility': 'EuroFins Dermscan Poland', 'geoPoint': {'lat': 54.35227, 'lon': 18.64912}}], 'overallOfficials': [{'name': 'Charlie Hee', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Allergan'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Allergan', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}