Ignite Creation Date:
2025-12-24 @ 10:08 PM
Ignite Modification Date:
2025-12-30 @ 2:16 PM
Study NCT ID:
NCT01029535
Status:
COMPLETED
Last Update Posted:
2016-03-09
First Post:
2009-12-08
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety and Efficacy of Juvederm® VOLUMA™ for Correction of Mid-face Volume Deficiency
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@allergan.com', 'phone': '714-246-4500', 'title': 'Vice President Medical Affairs,', 'organization': 'Allergan, Inc'}, 'certainAgreement': {'otherDetails': 'A disclosure restriction on the PI is that the sponsor can review results communications prior to release and can embargo communications regarding trial results for a period that is less than or equal to 120 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': {'description': '4 Participants did not complete Week 8 of Phase 1 and were not eligible for Phase 2.', 'eventGroups': [{'id': 'EG000', 'title': 'Juvederm® VOLUMA™_Phase 1', 'description': "Juvederm® VOLUMA™ injected in both sides of face (up to 4 mL per side) at Investigator's discretion to achieve at least a 2-point improvement in the Mid-face Volume Deficit Scale. Participants who completed Week 8 of Phase 1 were eligible to participate in Phase 2 and could receive an additional optional treatment if applicable.", 'otherNumAtRisk': 103, 'otherNumAffected': 65, 'seriousNumAtRisk': 103, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Juvederm® VOLUMA™_Phase 2', 'description': "Juvederm® VOLUMA™ injected in both sides of face (up to 4 mL per side) at Investigator's discretion to achieve at least a 2-point improvement in the Mid-face Volume Deficit Scale. Participants who completed Week 8 of Phase 1 were eligible to participate in Phase 2 and could receive an additional optional treatment if applicable.", 'otherNumAtRisk': 99, 'otherNumAffected': 8, 'seriousNumAtRisk': 99, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 49}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain of skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Swelling face', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 5}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Facial swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': "Percentage of Participants With a ≥ 1 Point Improvement From Baseline in the Subject's Global Aesthetic Improvement Scale (GAIS) at Week 4", 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Juvederm® VOLUMA™', 'description': "Juvederm® VOLUMA™ injected in both sides of face (up to 4 mL per side) at Investigator's discretion to achieve at least a 2-point improvement in the Mid-face Volume Deficit Scale. Participants who completed Week 8 of Phase 1 were eligible to participate in Phase 2 and could receive an additional optional treatment if applicable."}], 'classes': [{'categories': [{'measurements': [{'value': '97.06', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 4', 'description': 'The participant rated their midface appearance compared to Baseline (before treatment) using the 5-point GAIS scale where:-2=much worse to +2=much improved. The percentage of participants +1=improved and +2=much improved is reported.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the intent-to-treat (ITT) population, all enrolled participants who received at least one application of VOLUMA™, with data available for analysis.'}, {'type': 'PRIMARY', 'title': "Percentage of Participants With a ≥ 1 Point Improvement From Baseline in the Subject's Global Aesthetic Improvement Scale (GAIS) at Week 8", 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Juvederm® VOLUMA™', 'description': "Juvederm® VOLUMA™ injected in both sides of face (up to 4 mL per side) at Investigator's discretion to achieve at least a 2-point improvement in the Mid-face Volume Deficit Scale. Participants who completed Week 8 of Phase 1 were eligible to participate in Phase 2 and could receive an additional optional treatment if applicable."}], 'classes': [{'categories': [{'measurements': [{'value': '97.98', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 8', 'description': 'The participant rated their midface appearance compared to Baseline (before treatment) using the 5-point GAIS scale:-2=much worse to +2=much improved. The percentage of participants +1=improved and +2=much improved is reported.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the ITT population, all enrolled participants who received at least one application of VOLUMA™, with data available for analysis.'}, {'type': 'PRIMARY', 'title': "Percentage of Participants With a ≥ 1 Point Improvement From Baseline in the Physician's Global Aesthetic Improvement Scale (GAIS) at Week 4", 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Juvederm® VOLUMA™', 'description': "Juvederm® VOLUMA™ injected in both sides of face (up to 4 mL per side) at Investigator's discretion to achieve at least a 2-point improvement in the Mid-face Volume Deficit Scale. Participants who completed Week 8 of Phase 1 were eligible to participate in Phase 2 and could receive an additional optional treatment if applicable."}], 'classes': [{'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 4', 'description': "The physician rated the participant's midface appearance compared to Baseline (before treatment) using the 5-point GAIS scale:-2=much worse to +2=much improved. The percentage of participants +1=improved and +2=much improved is reported.", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the ITT population, all enrolled participants who received at least one application of VOLUMA™, with data available for analysis.'}, {'type': 'PRIMARY', 'title': "Percentage of Participants With a ≥ 1 Point Improvement From Baseline in the Physician's Global Aesthetic Improvement Scale (GAIS) at Week 8", 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Juvederm® VOLUMA™', 'description': "Juvederm® VOLUMA™ injected in both sides of face (up to 4 mL per side) at Investigator's discretion to achieve at least a 2-point improvement in the Mid-face Volume Deficit Scale. Participants who completed Week 8 of Phase 1 were eligible to participate in Phase 2 and could receive an additional optional treatment if applicable."}], 'classes': [{'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 8', 'description': "The physician rated the participant's midface appearance compared to Baseline (before treatment) using the 5-point GAIS scale:-2=much worse to +2=much improved. The percentage of participants +1=improved and +2=much improved is reported.", 'unitOfMeasure': 'percentage of particpants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the ITT population, all enrolled participants who received at least one application of VOLUMA™, with data available for analysis.'}, {'type': 'PRIMARY', 'title': "Percentage of Participants a ≥1 Point Improvement From Baseline in the Physician's Mid-face Volume Deficit Scale (MFVDS) at Week 4", 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Juvederm® VOLUMA™', 'description': "Juvederm® VOLUMA™ injected in both sides of face (up to 4 mL per side) at Investigator's discretion to achieve at least a 2-point improvement in the Mid-face Volume Deficit Scale. Participants who completed Week 8 of Phase 1 were eligible to participate in Phase 2 and could receive an additional optional treatment if applicable."}], 'classes': [{'categories': [{'measurements': [{'value': '92.23', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 4', 'description': 'The physician determined the degree of midface volume deficiency in each participant, relative to Baseline (before treatment) using the 6-point MFVDS: 0=no facial volume loss to 5=severe volume loss.', 'unitOfMeasure': 'percentage of particpants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all enrolled participants who received at least one application of VOLUMA™.'}, {'type': 'PRIMARY', 'title': "Percentage of Participants a ≥ 1 Point Improvement From Baseline in the Physician's Mid-face Volume Deficit Scale (MFVDS) at Week 8", 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Juvederm® VOLUMA™', 'description': "Juvederm® VOLUMA™ injected in both sides of face (up to 4 mL per side) at Investigator's discretion to achieve at least a 2-point improvement in the Mid-face Volume Deficit Scale. Participants who completed Week 8 of Phase 1 were eligible to participate in Phase 2 and could receive an additional optional treatment if applicable."}], 'classes': [{'categories': [{'measurements': [{'value': '95.96', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 8', 'description': 'The physician determined the degree of midface volume deficiency in each participant, relative to Baseline (before treatment) using the 6-point MFVDS: 0=no facial volume loss to 5=severe volume loss.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the ITT population, all enrolled participants who received at least one application of VOLUMA™, with data available for analysis.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Who Maintained Their Week 8 MFVDS Scores at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Juvederm® VOLUMA™', 'description': "Juvederm® VOLUMA™ injected in both sides of face (up to 4 mL per side) at Investigator's discretion to achieve at least a 2-point improvement in the Mid-face Volume Deficit Scale. Participants who completed Week 8 of Phase 1 were eligible to participate in Phase 2 and could receive an additional optional treatment if applicable."}], 'classes': [{'categories': [{'measurements': [{'value': '40.8', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 8, Week 52', 'description': 'The physician determined the degree of midface volume deficiency in each participant at week 8 and Week 52, relative to before treatment using the 6-point MFVDS: 0-no facial volume loss to 5=severe volume loss. The percentage of participants who are able to maintain their Week 8 score is reported.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all enrolled participants who received at least one application of VOLUMA™.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Who Maintained Their Week 8 MFVDS Scores at Week 78', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Juvederm® VOLUMA™', 'description': "Juvederm® VOLUMA™ injected in both sides of face (up to 4 mL per side) at Investigator's discretion to achieve at least a 2-point improvement in the Mid-face Volume Deficit Scale. Participants who completed Week 8 of Phase 1 were eligible to participate in Phase 2 and could receive an additional optional treatment if applicable."}], 'classes': [{'categories': [{'measurements': [{'value': '30.1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 8, Week 78', 'description': 'The physician determined the degree of midface volume deficiency in each participant at week 8 and Week 78, relative to before treatment using the 6-point MFVDS: 0-no facial volume loss to 5=severe volume loss. The percentage of participants who are able to maintain their Week 8 score is reported.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all enrolled participants who received at least one application of VOLUMA™.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Who Maintained Their Week 8 MFVDS Scores at Week 104', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Juvederm® VOLUMA™', 'description': "Juvederm® VOLUMA™ injected in both sides of face (up to 4 mL per side) at Investigator's discretion to achieve at least a 2-point improvement in the Mid-face Volume Deficit Scale. Participants who completed Week 8 of Phase 1 were eligible to participate in Phase 2 and could receive an additional optional treatment if applicable."}], 'classes': [{'categories': [{'measurements': [{'value': '38.8', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 8, Week 104', 'description': 'The physician determined the degree of midface volume deficiency in each participant at week 8 and Week 104, relative to before treatment using the 6-point MFVDS: 0-no facial volume loss to 5=severe volume loss. The percentage of participants who are able to maintain their Week 8 score is reported.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all enrolled participants who received at least one application of VOLUMA™.'}, {'type': 'PRIMARY', 'title': "Percentage of Participants Who Maintained Their Week 8 Subject's GAIS Scores at Week 52", 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Juvederm® VOLUMA™', 'description': "Juvederm® VOLUMA™ injected in both sides of face (up to 4 mL per side) at Investigator's discretion to achieve at least a 2-point improvement in the Mid-face Volume Deficit Scale. Participants who completed Week 8 of Phase 1 were eligible to participate in Phase 2 and could receive an additional optional treatment if applicable."}], 'classes': [{'categories': [{'measurements': [{'value': '41.7', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 8, Week 52', 'description': 'The participant rated their midface appearance compared to before treatment at Week 8 and Week 52 using the 5-point GAIS scale:-2=much worse to +2=much improved. The percentage of participants who are able to maintain their Week 8 score is reported.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all enrolled participants who received at least one application of VOLUMA™.'}, {'type': 'PRIMARY', 'title': "Percentage of Participants Who Maintained Their Week 8 Subject's GAIS Scores at Week 78", 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Juvederm® VOLUMA™', 'description': "Juvederm® VOLUMA™ injected in both sides of face (up to 4 mL per side) at Investigator's discretion to achieve at least a 2-point improvement in the Mid-face Volume Deficit Scale. Participants who completed Week 8 of Phase 1 were eligible to participate in Phase 2 and could receive an additional optional treatment if applicable."}], 'classes': [{'categories': [{'measurements': [{'value': '36.9', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 8, Week 78', 'description': 'The participant rated their midface appearance compared to before treatment at Week 8 and Week 78 using the 5-point GAIS scale:-2=much worse to +2=much improved. The percentage of participants who are able to maintain their Week 8 score is reported.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all enrolled participants who received at least one application of VOLUMA™.'}, {'type': 'PRIMARY', 'title': "Percentage of Participants Who Maintained Their Week 8 Subject's GAIS Scores at Week 104", 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Juvederm® VOLUMA™', 'description': "Juvederm® VOLUMA™ injected in both sides of face (up to 4 mL per side) at Investigator's discretion to achieve at least a 2-point improvement in the Mid-face Volume Deficit Scale. Participants who completed Week 8 of Phase 1 were eligible to participate in Phase 2 and could receive an additional optional treatment if applicable."}], 'classes': [{'categories': [{'measurements': [{'value': '36.9', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 8, Week 104', 'description': 'The participant rated their midface appearance compared to before treatment at Week 8 and Week 104 using the 5-point GAIS scale:-2=much worse to +2=much improved. The percentage of participants who are able to maintain their Week 8 score is reported.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all enrolled participants who received at least one application of VOLUMA™.'}, {'type': 'PRIMARY', 'title': "Percentage of Participants Who Maintained Their Week 8 Physician's GAIS Scores at Week 52", 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Juvederm® VOLUMA™', 'description': "Juvederm® VOLUMA™ injected in both sides of face (up to 4 mL per side) at Investigator's discretion to achieve at least a 2-point improvement in the Mid-face Volume Deficit Scale. Participants who completed Week 8 of Phase 1 were eligible to participate in Phase 2 and could receive an additional optional treatment if applicable."}], 'classes': [{'categories': [{'measurements': [{'value': '32.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 8, Week 52', 'description': "The physician rated the participant's midface appearance compared to before treatment at Week 8 and Week 52 using the 5-point GAIS scale:-2=much worse to +2=much improved. The percentage of participants who are able to maintain their Week 8 score is reported.", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all enrolled participants who received at least one application of VOLUMA™.'}, {'type': 'PRIMARY', 'title': "Percentage of Participants Who Maintained Their Week 8 Physician's GAIS Scores at Week 78", 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Juvederm® VOLUMA™', 'description': "Juvederm® VOLUMA™ injected in both sides of face (up to 4 mL per side) at Investigator's discretion to achieve at least a 2-point improvement in the Mid-face Volume Deficit Scale. Participants who completed Week 8 of Phase 1 were eligible to participate in Phase 2 and could receive an additional optional treatment if applicable."}], 'classes': [{'categories': [{'measurements': [{'value': '28.2', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 8, Week 78', 'description': "The physician rated the participant's midface appearance compared to before treatment at Week 8 and Week 78 using the 5-point GAIS scale:-2=much worse to +2=much improved. The percentage of participants who are able to maintain their Week 8 score is reported.", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all enrolled participants who received at least one application of VOLUMA™.'}, {'type': 'PRIMARY', 'title': "Percentage of Participants Who Maintained Their Week 8 Physician's GAIS Scores at Week 104", 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Juvederm® VOLUMA™', 'description': "Juvederm® VOLUMA™ injected in both sides of face (up to 4 mL per side) at Investigator's discretion to achieve at least a 2-point improvement in the Mid-face Volume Deficit Scale. Participants who completed Week 8 of Phase 1 were eligible to participate in Phase 2 and could receive an additional optional treatment if applicable."}], 'classes': [{'categories': [{'measurements': [{'value': '29.1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 8, Week 104', 'description': "The physician rated the participant's midface appearance compared to before treatment at Week 8 and Week 104 using the 5-point GAIS scale:-2=much worse to +2=much improved. The percentage of participants who are able to maintain their Week 8 score is reported.", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all enrolled participants who received at least one application of VOLUMA™.'}, {'type': 'SECONDARY', 'title': "Percentage of Participants With a ≥ 1 Point Improvement From Baseline in the Investigator's Wrinkle Assessment Scale (WAS)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Juvederm® VOLUMA™', 'description': "Juvederm® VOLUMA™ injected in both sides of face (up to 4 mL per side) at Investigator's discretion to achieve at least a 2-point improvement in the Mid-face Volume Deficit Scale. Participants who completed Week 8 of Phase 1 were eligible to participate in Phase 2 and could receive an additional optional treatment if applicable."}], 'classes': [{'title': 'Left Side Week 4 (n=103)', 'categories': [{'measurements': [{'value': '35.92', 'groupId': 'OG000'}]}]}, {'title': 'Left Side Week 8 (n=99)', 'categories': [{'measurements': [{'value': '45.45', 'groupId': 'OG000'}]}]}, {'title': 'Left Side Week 52 (n=68)', 'categories': [{'measurements': [{'value': '36.76', 'groupId': 'OG000'}]}]}, {'title': 'Left Side Week 78 (n=82)', 'categories': [{'measurements': [{'value': '42.68', 'groupId': 'OG000'}]}]}, {'title': 'Left Side Week 104 (n=72)', 'categories': [{'measurements': [{'value': '48.61', 'groupId': 'OG000'}]}]}, {'title': 'Right Side Week 4 (n=103)', 'categories': [{'measurements': [{'value': '34.95', 'groupId': 'OG000'}]}]}, {'title': 'Right Side Week 8 (n=99)', 'categories': [{'measurements': [{'value': '43.43', 'groupId': 'OG000'}]}]}, {'title': 'Right Side Week 52 (n=68)', 'categories': [{'measurements': [{'value': '27.94', 'groupId': 'OG000'}]}]}, {'title': 'Right Side Week 78 (n=82)', 'categories': [{'measurements': [{'value': '41.46', 'groupId': 'OG000'}]}]}, {'title': 'Right Side Week 104 (n=72)', 'categories': [{'measurements': [{'value': '44.44', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Weeks 4, 8, 52, 78 and 104', 'description': "The physician assessed the left side and the right side of the participant's face for severity of nasolabial folds using the 5-point WAS where: 0=no wrinkle to 4=very deep wrinkle.", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the ITT population, all enrolled participants who received at least one application of VOLUMA™, with data available for analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the MFVDS Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Juvederm® VOLUMA™', 'description': "Juvederm® VOLUMA™ injected in both sides of face (up to 4 mL per side) at Investigator's discretion to achieve at least a 2-point improvement in the Mid-face Volume Deficit Scale. Participants who completed Week 8 of Phase 1 were eligible to participate in Phase 2 and could receive an additional optional treatment if applicable."}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '3.45', 'spread': '0.75', 'groupId': 'OG000'}]}]}, {'title': 'Change from Baseline at Week 4', 'categories': [{'measurements': [{'value': '1.58', 'spread': '0.83', 'groupId': 'OG000'}]}]}, {'title': 'Change from Baseline at Week 8 (n=99)', 'categories': [{'measurements': [{'value': '2.03', 'spread': '0.91', 'groupId': 'OG000'}]}]}, {'title': 'Change from Baseline at Week 52 (n=68)', 'categories': [{'measurements': [{'value': '1.68', 'spread': '0.95', 'groupId': 'OG000'}]}]}, {'title': 'Change from Baseline at Week 78 (n=82)', 'categories': [{'measurements': [{'value': '1.44', 'spread': '1.04', 'groupId': 'OG000'}]}]}, {'title': 'Change from Baseline at Week 104 (n=72)', 'categories': [{'measurements': [{'value': '1.72', 'spread': '0.95', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 4, 8, 52, 78 and 104', 'description': 'The physician determined the degree of midface volume deficiency in each participant, relative to Baseline (before treatment) using the 6-point MFVDS where: 0=no facial volume loss to 5=severe volume loss. A negative change from Baseline indicates improvement.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the ITT population, all enrolled participants who received at least one application of VOLUMA™, with data available for analysis.'}, {'type': 'SECONDARY', 'title': 'Physician Assessment of Global Aesthetic Improvement Score (GAIS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Juvederm® VOLUMA™', 'description': "Juvederm® VOLUMA™ injected in both sides of face (up to 4 mL per side) at Investigator's discretion to achieve at least a 2-point improvement in the Mid-face Volume Deficit Scale. Participants who completed Week 8 of Phase 1 were eligible to participate in Phase 2 and could receive an additional optional treatment if applicable."}], 'classes': [{'title': 'Week 4 (n=102)', 'categories': [{'measurements': [{'value': '1.35', 'spread': '0.48', 'groupId': 'OG000'}]}]}, {'title': 'Week 8 (n=99)', 'categories': [{'measurements': [{'value': '1.76', 'spread': '0.43', 'groupId': 'OG000'}]}]}, {'title': 'Week 52 (n=68)', 'categories': [{'measurements': [{'value': '1.13', 'spread': '0.81', 'groupId': 'OG000'}]}]}, {'title': 'Week 78 (n=82)', 'categories': [{'measurements': [{'value': '0.85', 'spread': '0.90', 'groupId': 'OG000'}]}]}, {'title': 'Week 104 (n=72)', 'categories': [{'measurements': [{'value': '1.14', 'spread': '0.74', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 4, 8, 52, 78 and 104', 'description': "The physician rated the participant's midface appearance compared to Baseline (before treatment) using the 5-point GAIS scale:-2=much worse to +2=much improved.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the ITT population, all enrolled participants who received at least one application of VOLUMA™, with data available for analysis.'}, {'type': 'SECONDARY', 'title': "Subject's Assessment of Global Aesthetic Improvement Score (GAIS)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Juvederm® VOLUMA™', 'description': "Juvederm® VOLUMA™ injected in both sides of face (up to 4 mL per side) at Investigator's discretion to achieve at least a 2-point improvement in the Mid-face Volume Deficit Scale. Participants who completed Week 8 of Phase 1 were eligible to participate in Phase 2 and could receive an additional optional treatment if applicable."}], 'classes': [{'title': 'Week 4 (n=102)', 'categories': [{'measurements': [{'value': '1.31', 'spread': '0.52', 'groupId': 'OG000'}]}]}, {'title': 'Week 8 (n=99)', 'categories': [{'measurements': [{'value': '1.55', 'spread': '0.61', 'groupId': 'OG000'}]}]}, {'title': 'Week 52 (n=68)', 'categories': [{'measurements': [{'value': '1.01', 'spread': '0.86', 'groupId': 'OG000'}]}]}, {'title': 'Week 78 (n=82)', 'categories': [{'measurements': [{'value': '0.79', 'spread': '0.94', 'groupId': 'OG000'}]}]}, {'title': 'Week 104 (n=72)', 'categories': [{'measurements': [{'value': '0.97', 'spread': '0.77', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 4, 8, 52, 78 and 104', 'description': 'The participant rated their midface appearance compared to Baseline (before treatment) using the 5-point GAIS scale:-2=much worse to +2=much improved.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the ITT population, all enrolled participants who received at least one application of VOLUMA™, with data available for analysis.'}, {'type': 'SECONDARY', 'title': "Change From Baseline in the Subject's Self-Perception of Age (SPA)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Juvederm® VOLUMA™', 'description': "Juvederm® VOLUMA™ injected in both sides of face (up to 4 mL per side) at Investigator's discretion to achieve at least a 2-point improvement in the Mid-face Volume Deficit Scale. Participants who completed Week 8 of Phase 1 were eligible to participate in Phase 2 and could receive an additional optional treatment if applicable."}], 'classes': [{'title': 'Change from Baseline at Week 4 (n=101)', 'categories': [{'measurements': [{'value': '-3.03', 'spread': '3.45', 'groupId': 'OG000'}]}]}, {'title': 'Change from Baseline at Week 8 (n=98)', 'categories': [{'measurements': [{'value': '-3.74', 'spread': '3.99', 'groupId': 'OG000'}]}]}, {'title': 'Change from Baseline at Week 52 (n=68)', 'categories': [{'measurements': [{'value': '-3.15', 'spread': '4.48', 'groupId': 'OG000'}]}]}, {'title': 'Change from Baseline at Week 78 (n=82)', 'categories': [{'measurements': [{'value': '-2.88', 'spread': '4.09', 'groupId': 'OG000'}]}]}, {'title': 'Change from Baseline at Week 104 (n=72)', 'categories': [{'measurements': [{'value': '-3.85', 'spread': '4.01', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 4, 8, 52, 78 and 104', 'description': 'The participant rated their facial age in years at Baseline and Weeks 4, 8, 52, 78 and 104. A negative change from Baseline indicates an improvement.', 'unitOfMeasure': 'years', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the ITT population, all enrolled participants who received at least one application of VOLUMA™, with data available for analysis.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Satisfied or Very Satisfied With the Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Juvederm® VOLUMA™', 'description': "Juvederm® VOLUMA™ injected in both sides of face (up to 4 mL per side) at Investigator's discretion to achieve at least a 2-point improvement in the Mid-face Volume Deficit Scale. Participants who completed Week 8 of Phase 1 were eligible to participate in Phase 2 and could receive an additional optional treatment if applicable."}], 'classes': [{'title': 'Very Satisfied', 'categories': [{'measurements': [{'value': '66.7', 'groupId': 'OG000'}]}]}, {'title': 'Satisfied', 'categories': [{'measurements': [{'value': '24.2', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 8', 'description': 'Participants rated their satisfaction with treatment using a 5-Point Scale where: 1=very unsatisfied to 5=very satisfied.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the ITT population, all enrolled participants who received at least one application of VOLUMA™, with data available for analysis.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Juvederm® VOLUMA™', 'description': "Juvederm® VOLUMA™ injected in both sides of face (up to 4 mL per side) at Investigator's discretion to achieve at least a 2-point improvement in the Mid-face Volume Deficit Scale. Participants who completed Week 8 of Phase 1 were eligible to participate in Phase 2 and could receive an additional optional treatment if applicable."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '103'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '72'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '31'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '24'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Participant Withdrew Consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Use of Another Treatment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Juvederm® VOLUMA™', 'description': "Juvederm® VOLUMA™ injected in both sides of face (up to 4 mL per side) at Investigator's discretion to achieve at least a 2-point improvement in the Mid-face Volume Deficit Scale. Participants who completed Week 8 of Phase 1 were eligible to participate in Phase 2 and could receive an additional optional treatment if applicable."}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '103', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '46.7', 'groupId': 'BG000', 'lowerLimit': '29', 'upperLimit': '63'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '83', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '20', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 103}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'completionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-02-08', 'studyFirstSubmitDate': '2009-12-08', 'resultsFirstSubmitDate': '2012-05-01', 'studyFirstSubmitQcDate': '2009-12-09', 'lastUpdatePostDateStruct': {'date': '2016-03-09', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-01-17', 'studyFirstPostDateStruct': {'date': '2009-12-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-02-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Percentage of Participants With a ≥ 1 Point Improvement From Baseline in the Subject's Global Aesthetic Improvement Scale (GAIS) at Week 4", 'timeFrame': 'Baseline, Week 4', 'description': 'The participant rated their midface appearance compared to Baseline (before treatment) using the 5-point GAIS scale where:-2=much worse to +2=much improved. The percentage of participants +1=improved and +2=much improved is reported.'}, {'measure': "Percentage of Participants With a ≥ 1 Point Improvement From Baseline in the Subject's Global Aesthetic Improvement Scale (GAIS) at Week 8", 'timeFrame': 'Baseline, Week 8', 'description': 'The participant rated their midface appearance compared to Baseline (before treatment) using the 5-point GAIS scale:-2=much worse to +2=much improved. The percentage of participants +1=improved and +2=much improved is reported.'}, {'measure': "Percentage of Participants With a ≥ 1 Point Improvement From Baseline in the Physician's Global Aesthetic Improvement Scale (GAIS) at Week 4", 'timeFrame': 'Baseline, Week 4', 'description': "The physician rated the participant's midface appearance compared to Baseline (before treatment) using the 5-point GAIS scale:-2=much worse to +2=much improved. The percentage of participants +1=improved and +2=much improved is reported."}, {'measure': "Percentage of Participants With a ≥ 1 Point Improvement From Baseline in the Physician's Global Aesthetic Improvement Scale (GAIS) at Week 8", 'timeFrame': 'Baseline, Week 8', 'description': "The physician rated the participant's midface appearance compared to Baseline (before treatment) using the 5-point GAIS scale:-2=much worse to +2=much improved. The percentage of participants +1=improved and +2=much improved is reported."}, {'measure': "Percentage of Participants a ≥1 Point Improvement From Baseline in the Physician's Mid-face Volume Deficit Scale (MFVDS) at Week 4", 'timeFrame': 'Baseline, Week 4', 'description': 'The physician determined the degree of midface volume deficiency in each participant, relative to Baseline (before treatment) using the 6-point MFVDS: 0=no facial volume loss to 5=severe volume loss.'}, {'measure': "Percentage of Participants a ≥ 1 Point Improvement From Baseline in the Physician's Mid-face Volume Deficit Scale (MFVDS) at Week 8", 'timeFrame': 'Baseline, Week 8', 'description': 'The physician determined the degree of midface volume deficiency in each participant, relative to Baseline (before treatment) using the 6-point MFVDS: 0=no facial volume loss to 5=severe volume loss.'}, {'measure': 'Percentage of Participants Who Maintained Their Week 8 MFVDS Scores at Week 52', 'timeFrame': 'Baseline, Week 8, Week 52', 'description': 'The physician determined the degree of midface volume deficiency in each participant at week 8 and Week 52, relative to before treatment using the 6-point MFVDS: 0-no facial volume loss to 5=severe volume loss. The percentage of participants who are able to maintain their Week 8 score is reported.'}, {'measure': 'Percentage of Participants Who Maintained Their Week 8 MFVDS Scores at Week 78', 'timeFrame': 'Baseline, Week 8, Week 78', 'description': 'The physician determined the degree of midface volume deficiency in each participant at week 8 and Week 78, relative to before treatment using the 6-point MFVDS: 0-no facial volume loss to 5=severe volume loss. The percentage of participants who are able to maintain their Week 8 score is reported.'}, {'measure': 'Percentage of Participants Who Maintained Their Week 8 MFVDS Scores at Week 104', 'timeFrame': 'Baseline, Week 8, Week 104', 'description': 'The physician determined the degree of midface volume deficiency in each participant at week 8 and Week 104, relative to before treatment using the 6-point MFVDS: 0-no facial volume loss to 5=severe volume loss. The percentage of participants who are able to maintain their Week 8 score is reported.'}, {'measure': "Percentage of Participants Who Maintained Their Week 8 Subject's GAIS Scores at Week 52", 'timeFrame': 'Baseline, Week 8, Week 52', 'description': 'The participant rated their midface appearance compared to before treatment at Week 8 and Week 52 using the 5-point GAIS scale:-2=much worse to +2=much improved. The percentage of participants who are able to maintain their Week 8 score is reported.'}, {'measure': "Percentage of Participants Who Maintained Their Week 8 Subject's GAIS Scores at Week 78", 'timeFrame': 'Baseline, Week 8, Week 78', 'description': 'The participant rated their midface appearance compared to before treatment at Week 8 and Week 78 using the 5-point GAIS scale:-2=much worse to +2=much improved. The percentage of participants who are able to maintain their Week 8 score is reported.'}, {'measure': "Percentage of Participants Who Maintained Their Week 8 Subject's GAIS Scores at Week 104", 'timeFrame': 'Baseline, Week 8, Week 104', 'description': 'The participant rated their midface appearance compared to before treatment at Week 8 and Week 104 using the 5-point GAIS scale:-2=much worse to +2=much improved. The percentage of participants who are able to maintain their Week 8 score is reported.'}, {'measure': "Percentage of Participants Who Maintained Their Week 8 Physician's GAIS Scores at Week 52", 'timeFrame': 'Baseline, Week 8, Week 52', 'description': "The physician rated the participant's midface appearance compared to before treatment at Week 8 and Week 52 using the 5-point GAIS scale:-2=much worse to +2=much improved. The percentage of participants who are able to maintain their Week 8 score is reported."}, {'measure': "Percentage of Participants Who Maintained Their Week 8 Physician's GAIS Scores at Week 78", 'timeFrame': 'Baseline, Week 8, Week 78', 'description': "The physician rated the participant's midface appearance compared to before treatment at Week 8 and Week 78 using the 5-point GAIS scale:-2=much worse to +2=much improved. The percentage of participants who are able to maintain their Week 8 score is reported."}, {'measure': "Percentage of Participants Who Maintained Their Week 8 Physician's GAIS Scores at Week 104", 'timeFrame': 'Baseline, Week 8, Week 104', 'description': "The physician rated the participant's midface appearance compared to before treatment at Week 8 and Week 104 using the 5-point GAIS scale:-2=much worse to +2=much improved. The percentage of participants who are able to maintain their Week 8 score is reported."}], 'secondaryOutcomes': [{'measure': "Percentage of Participants With a ≥ 1 Point Improvement From Baseline in the Investigator's Wrinkle Assessment Scale (WAS)", 'timeFrame': 'Baseline, Weeks 4, 8, 52, 78 and 104', 'description': "The physician assessed the left side and the right side of the participant's face for severity of nasolabial folds using the 5-point WAS where: 0=no wrinkle to 4=very deep wrinkle."}, {'measure': 'Change From Baseline in the MFVDS Score', 'timeFrame': 'Baseline, Weeks 4, 8, 52, 78 and 104', 'description': 'The physician determined the degree of midface volume deficiency in each participant, relative to Baseline (before treatment) using the 6-point MFVDS where: 0=no facial volume loss to 5=severe volume loss. A negative change from Baseline indicates improvement.'}, {'measure': 'Physician Assessment of Global Aesthetic Improvement Score (GAIS)', 'timeFrame': 'Baseline, Weeks 4, 8, 52, 78 and 104', 'description': "The physician rated the participant's midface appearance compared to Baseline (before treatment) using the 5-point GAIS scale:-2=much worse to +2=much improved."}, {'measure': "Subject's Assessment of Global Aesthetic Improvement Score (GAIS)", 'timeFrame': 'Baseline, Weeks 4, 8, 52, 78 and 104', 'description': 'The participant rated their midface appearance compared to Baseline (before treatment) using the 5-point GAIS scale:-2=much worse to +2=much improved.'}, {'measure': "Change From Baseline in the Subject's Self-Perception of Age (SPA)", 'timeFrame': 'Baseline, Weeks 4, 8, 52, 78 and 104', 'description': 'The participant rated their facial age in years at Baseline and Weeks 4, 8, 52, 78 and 104. A negative change from Baseline indicates an improvement.'}, {'measure': 'Percentage of Participants Satisfied or Very Satisfied With the Treatment', 'timeFrame': 'Week 8', 'description': 'Participants rated their satisfaction with treatment using a 5-Point Scale where: 1=very unsatisfied to 5=very satisfied.'}]}, 'conditionsModule': {'conditions': ['Mid-face Volume Deficiency']}, 'referencesModule': {'references': [{'pmid': '23687448', 'type': 'BACKGROUND', 'citation': 'Callan P, Goodman GJ, Carlisle I, Liew S, Muzikants P, Scamp T, Halstead MB, Rogers JD. Efficacy and safety of a hyaluronic acid filler in subjects treated for correction of midface volume deficiency: a 24 month study. Clin Cosmet Investig Dermatol. 2013 Mar 20;6:81-9. doi: 10.2147/CCID.S40581. Print 2013.'}]}, 'descriptionModule': {'briefSummary': 'This is a prospective, open-label experience study to be conducted at 6 clinical sites in Australia, with the objective to collect efficacy and safety information for Juvederm® VOLUMA™ when used for volumising the mid-face and cheek area.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects with mild to severe mid-face and cheek volume deficit due to age-related changes, who are likely to improve by at least 2 grades following treatment with the study compound, based on a study-specific scale, as assessed by the study physician\n\nExclusion Criteria:\n\n* Subjects who have a pre-existing medical condition or who have received any treatments or procedures which may impact on the assessment of the effects of the study compound.\n* Subjects with a history of allergies or other side effects to dermal fillers, lidocaine, hyaluronic acid or other component of the study compound.\n* Subjects were are pregnant or breast-feeding or who are of child-bearing potential and who are not prepared to practice an adequate form of contraception during the course of the study\n* Subjects with a history of alcoholism or drug abuse or dependence'}, 'identificationModule': {'nctId': 'NCT01029535', 'briefTitle': 'Safety and Efficacy of Juvederm® VOLUMA™ for Correction of Mid-face Volume Deficiency', 'organization': {'class': 'INDUSTRY', 'fullName': 'Allergan'}, 'orgStudyIdInfo': {'id': 'VOL-AP01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Juvederm® VOLUMA™', 'description': "Juvederm® VOLUMA™ injected in both sides of face (up to 4 mL per side) at Investigator's discretion to achieve at least a 2-point improvement in the Mid-face Volume Deficit Scale. Participants who completed Week 8 of Phase 1 were eligible to participate in Phase 2 and could receive an additional optional treatment if applicable.", 'interventionNames': ['Device: Cross-linked hyaluronic acid gel']}], 'interventions': [{'name': 'Cross-linked hyaluronic acid gel', 'type': 'DEVICE', 'otherNames': ['Juvederm® VOLUMA™'], 'description': 'Cross-linked hyaluronic acid gel (Juvederm® VOLUMA™) up to 4 mLs injected in each side of the face.', 'armGroupLabels': ['Juvederm® VOLUMA™']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Sydney', 'country': 'Australia', 'geoPoint': {'lat': -33.86785, 'lon': 151.20732}}], 'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Allergan'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Allergan', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}