Ignite Creation Date:
2025-12-24 @ 7:49 PM
Ignite Modification Date:
2026-03-11 @ 1:02 AM
Study NCT ID:
NCT02437903
Status:
COMPLETED
Last Update Posted:
2018-02-15
First Post:
2015-04-30
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Open Label Study Evaluating the Efficacy and Safety of JUVÉDERM VOLUMA™ XC for the Facial Temporal Regions
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019066', 'term': 'Facies'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'studies@derm.net', 'phone': '(305) 531-5788', 'title': 'Leslie Baumann, MD', 'organization': 'Baumann Cosmetic and Research Institute'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Baseline, Month 1, Month 3, Month 6, Month 9, and Month 12', 'eventGroups': [{'id': 'EG000', 'title': 'JUVÉDERM VOLUMA™ XC', 'description': 'Subjects will be injected with JUVÉDERM VOLUMA™ XC to their right and left facial temporal regions at the baseline visit.\n\nJUVÉDERM VOLUMA™ XC: Subjects will receive up to 4, 1mL syringes of JUVÉDERM VOLUMA™ XC for their initial injection and a maximum of 6, 1mL syringes of JUVÉDERM VOLUMA™ XC for the study. Subjects will undergo one touch-up injection approximately 2 weeks post initial treatment, and will continue to be evaluated at month 1, month 3, and month 6.', 'otherNumAtRisk': 30, 'deathsNumAtRisk': 30, 'otherNumAffected': 1, 'seriousNumAtRisk': 30, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Unexpected Swelling', 'notes': 'Subject experienced unexpected swelling 28 days post injection. Device was removed immediately.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Frontal Temporal Fossa Rating Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'JUVÉDERM VOLUMA™ XC', 'description': 'Subjects will be injected with JUVÉDERM VOLUMA™ XC to their right and left facial temporal regions at the baseline visit.\n\nJUVÉDERM VOLUMA™ XC: Subjects will receive up to 4, 1mL syringes of JUVÉDERM VOLUMA™ XC for their initial injection and a maximum of 6, 1mL syringes of JUVÉDERM VOLUMA™ XC for the study. Subjects will undergo one touch-up injection approximately 2 weeks post initial treatment, and will continue to be evaluated at month 1, month 3, month 6, month 9, and month 12'}], 'classes': [{'title': 'Temporal Fossa Rating Scale at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Severe Concavity', 'measurements': [{'value': '10', 'groupId': 'OG000'}]}, {'title': 'Moderate Concavity', 'measurements': [{'value': '13', 'groupId': 'OG000'}]}, {'title': 'Mild Concavity', 'measurements': [{'value': '7', 'groupId': 'OG000'}]}, {'title': 'Flat', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Convexity', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Temporal Fossa Rating Scale at Month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Severe Concavity', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Moderate Concavity', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Mild Concavity', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Flat', 'measurements': [{'value': '27', 'groupId': 'OG000'}]}, {'title': 'Convexity', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Temporal Fossa Rating Scale at Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Severe Concavity', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Moderate Concavity', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Mild Concavity', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}, {'title': 'Flat', 'measurements': [{'value': '22', 'groupId': 'OG000'}]}, {'title': 'Convexity', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Temporal Fossa Rating Scale at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Severe Concavity', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Moderate Concavity', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Mild Concavity', 'measurements': [{'value': '8', 'groupId': 'OG000'}]}, {'title': 'Flat', 'measurements': [{'value': '18', 'groupId': 'OG000'}]}, {'title': 'Convexity', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Temporal Fossa Rating Scale at Month 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Severe Concavity', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Moderate Concavity', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'Mild Concavity', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'Flat', 'measurements': [{'value': '21', 'groupId': 'OG000'}]}, {'title': 'Convexity', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Temporal Fossa Rating Scale at Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Severe Concavity', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Moderate Concavity', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Mild Concavity', 'measurements': [{'value': '5', 'groupId': 'OG000'}]}, {'title': 'Flat', 'measurements': [{'value': '20', 'groupId': 'OG000'}]}, {'title': 'Convexity', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline, Month 1, Month 3, Month 6, Month 9, and Month 12', 'description': 'Graded severity of the temporal line of the frontal bone (TLFB) using the Frontal Temporal Fossa Rating Scale: (these will have a picture assigned to each score.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects with data for for this outcome measure'}, {'type': 'SECONDARY', 'title': "Investigator's Satisfaction With the Appearance of the Temporal Regions", 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'JUVÉDERM VOLUMA™ XC', 'description': 'Subjects will be injected with JUVÉDERM VOLUMA™ XC to their right and left facial temporal regions at the baseline visit.\n\nJUVÉDERM VOLUMA™ XC: Subjects will receive up to 4, 1mL syringes of JUVÉDERM VOLUMA™ XC for their initial injection and a maximum of 6, 1mL syringes of JUVÉDERM VOLUMA™ XC for the study. Subjects will undergo one touch-up injection approximately 2 weeks post initial treatment, and will continue to be evaluated at month 1, month 3, and month 6.'}], 'classes': [{'title': "Investigator's Satisfaction at Baseline", 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Very Satisfied', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Moderately Satisfied', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Somewhat Satisfied', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Neither', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Somewhat Dissatisfied', 'measurements': [{'value': '6', 'groupId': 'OG000'}]}, {'title': 'Moderately Dissatisfied', 'measurements': [{'value': '12', 'groupId': 'OG000'}]}, {'title': 'Very Dissatisfied', 'measurements': [{'value': '12', 'groupId': 'OG000'}]}]}, {'title': "Investigator's Satisfaction at Month 1", 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Very Satisfied', 'measurements': [{'value': '24', 'groupId': 'OG000'}]}, {'title': 'Moderately Satisfied', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}, {'title': 'Somewhat Satisfied', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Neither', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Somewhat Dissatisfied', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Moderately Dissatisfied', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Very Dissatisfied', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': "Investigator's Satisfaction at Month 3", 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Very Satisfied', 'measurements': [{'value': '23', 'groupId': 'OG000'}]}, {'title': 'Moderately Satisfied', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': 'Somewhat Satisfied', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Neither', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Somewhat Dissatisfied', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Moderately Dissatisfied', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Very Dissatisfied', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': "Investigator's Satisfaction at Month 6", 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Very Satisfied', 'measurements': [{'value': '18', 'groupId': 'OG000'}]}, {'title': 'Moderately Satisfied', 'measurements': [{'value': '7', 'groupId': 'OG000'}]}, {'title': 'Somewhat Satisfied', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Neither', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Somewhat Dissatisfied', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Moderately Dissatisfied', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Very Dissatisfied', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': "Investigator's Satisfaction at Month 9", 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Very Satisfied', 'measurements': [{'value': '19', 'groupId': 'OG000'}]}, {'title': 'Moderately Satisfied', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': 'Somewhat Satisfied', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Neither', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Somewhat Dissatisfied', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Moderately Dissatisfied', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'Very Dissatisfied', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': "Investigator's Satisfaction at Month 12", 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Very Satisfied', 'measurements': [{'value': '16', 'groupId': 'OG000'}]}, {'title': 'Moderately Satisfied', 'measurements': [{'value': '5', 'groupId': 'OG000'}]}, {'title': 'Somewhat Satisfied', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': 'Neither', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Somewhat Dissatisfied', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Moderately Dissatisfied', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Very Dissatisfied', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline, Month 1, Month 3, Month 6, Month 9, and Month 12', 'description': "Graded level of satisfaction with the current appearance of the temporal region making certain that the investigator is looking at the patient's right side and not the investigator's right side.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects with data for this outcome measure'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': "Subject's Satisfaction With Temple Appearance", 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'JUVÉDERM VOLUMA™ XC', 'description': 'Subjects will be injected with JUVÉDERM VOLUMA™ XC to their right and left facial temporal regions at the baseline visit.\n\nJUVÉDERM VOLUMA™ XC: Subjects will receive up to 4, 1mL syringes of JUVÉDERM VOLUMA™ XC for their initial injection and a maximum of 6, 1mL syringes of JUVÉDERM VOLUMA™ XC for the study. Subjects will undergo one touch-up injection approximately 2 weeks post initial treatment, and will continue to be evaluated at month 1, month 3, and month 6.'}], 'classes': [{'title': "Subject's Satisfaction at Baseline", 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Very Satisfied', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Moderately Satisfied', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Somewhat Satisfied', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Neither', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'Somewhat Dissatisfied', 'measurements': [{'value': '10', 'groupId': 'OG000'}]}, {'title': 'Moderately Dissatisfied', 'measurements': [{'value': '9', 'groupId': 'OG000'}]}, {'title': 'Very Dissatisfied', 'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}, {'title': "Subject's Satisfaction at Month 1", 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Very Satisfied', 'measurements': [{'value': '18', 'groupId': 'OG000'}]}, {'title': 'Moderately Satisfied', 'measurements': [{'value': '9', 'groupId': 'OG000'}]}, {'title': 'Somewhat Satisfied', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Neither', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Somewhat Dissatisfied', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Moderately Dissatisfied', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Very Dissatisfied', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': "Subject's Satisfaction at Month 3", 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Very Satisfied', 'measurements': [{'value': '21', 'groupId': 'OG000'}]}, {'title': 'Moderately Satisfied', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': 'Somewhat Satisfied', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'Neither', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Somewhat Dissatisfied', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Moderately Dissatisfied', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Very Dissatisfied', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': "Subject's Satisfaction at Month 6", 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Very Satisfied', 'measurements': [{'value': '15', 'groupId': 'OG000'}]}, {'title': 'Moderately Satisfied', 'measurements': [{'value': '7', 'groupId': 'OG000'}]}, {'title': 'Somewhat Satisfied', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': 'Neither', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Somewhat Dissatisfied', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Moderately Dissatisfied', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Very Dissatisfied', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': "Subject's Satisfaction at Month 9", 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Very Satisfied', 'measurements': [{'value': '13', 'groupId': 'OG000'}]}, {'title': 'Moderately Satisfied', 'measurements': [{'value': '6', 'groupId': 'OG000'}]}, {'title': 'Somewhat Satisfied', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}, {'title': 'Neither', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Somewhat Dissatisfied', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Moderately Dissatisfied', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Very Dissatisfied', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': "Subject's Satisfaction at Month 12", 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Very Satisfied', 'measurements': [{'value': '14', 'groupId': 'OG000'}]}, {'title': 'Moderately Satisfied', 'measurements': [{'value': '5', 'groupId': 'OG000'}]}, {'title': 'Somewhat Satisfied', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': 'Neither', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Somewhat Dissatisfied', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Moderately Dissatisfied', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Very Dissatisfied', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline, month 1, month 3, month 6, month 9, and Month 12', 'description': "Subject's Satisfaction with Temple Appearance", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects with data for this outcome measure'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Subject Self-Perception of Age', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'JUVÉDERM VOLUMA™ XC', 'description': 'Subjects will be injected with JUVÉDERM VOLUMA™ XC to their right and left facial temporal regions at the baseline visit.\n\nJUVÉDERM VOLUMA™ XC: Subjects will receive up to 4, 1mL syringes of JUVÉDERM VOLUMA™ XC for their initial injection and a maximum of 6, 1mL syringes of JUVÉDERM VOLUMA™ XC for the study. Subjects will undergo one touch-up injection approximately 2 weeks post initial treatment, and will continue to be evaluated at month 1, month 3, and month 6.'}], 'classes': [{'title': 'Subjects perception of age at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Same or Older', 'measurements': [{'value': '23', 'groupId': 'OG000'}]}, {'title': '1-5 Years Younger', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}, {'title': '6-10 Years Younger', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': '11-15 Years Younger', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': '16+ Years Younger', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Returned to Baseline', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Subjects perception of age at Month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Same or Older', 'measurements': [{'value': '5', 'groupId': 'OG000'}]}, {'title': '1-5 Years Younger', 'measurements': [{'value': '14', 'groupId': 'OG000'}]}, {'title': '6-10 Years Younger', 'measurements': [{'value': '9', 'groupId': 'OG000'}]}, {'title': '11-15 Years Younger', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': '16+ Years Younger', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Returned to Baseline', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Subjects perception of age at Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Same or Older', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': '1-5 Years Younger', 'measurements': [{'value': '12', 'groupId': 'OG000'}]}, {'title': '6-10 Years Younger', 'measurements': [{'value': '8', 'groupId': 'OG000'}]}, {'title': '11-15 Years Younger', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': '16+ Years Younger', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Returned to Baseline', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Subjects perception of age at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Same or Older', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': '1-5 Years Younger', 'measurements': [{'value': '12', 'groupId': 'OG000'}]}, {'title': '6-10 Years Younger', 'measurements': [{'value': '10', 'groupId': 'OG000'}]}, {'title': '11-15 Years Younger', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': '16+ Years Younger', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Returned to Baseline', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Subjects perception of age at Month 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Same or Older', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': '1-5 Years Younger', 'measurements': [{'value': '11', 'groupId': 'OG000'}]}, {'title': '6-10 Years Younger', 'measurements': [{'value': '7', 'groupId': 'OG000'}]}, {'title': '11-15 Years Younger', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': '16+ Years Younger', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Returned to Baseline', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Subjects perception of age Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Same or Older', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': '1-5 Years Younger', 'measurements': [{'value': '12', 'groupId': 'OG000'}]}, {'title': '6-10 Years Younger', 'measurements': [{'value': '8', 'groupId': 'OG000'}]}, {'title': '11-15 Years Younger', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': '16+ Years Younger', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Returned to Baseline', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline, month 1, month 3, month 6, month 9, and Month 12', 'description': 'Subjects perception of age when the subject looks at his/her right and left temples', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects with data for this outcome measure'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants With Specific Site Treatment Responses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'JUVÉDERM VOLUMA™ XC', 'description': 'Subjects will be injected with JUVÉDERM VOLUMA™ XC to their right and left facial temporal regions at the baseline visit.\n\nJUVÉDERM VOLUMA™ XC: Subjects will receive up to 4, 1mL syringes of JUVÉDERM VOLUMA™ XC for their initial injection and a maximum of 6, 1mL syringes of JUVÉDERM VOLUMA™ XC for the study. Subjects will undergo one touch-up injection approximately 2 weeks post initial treatment, and will continue to be evaluated at month 1, month 3, and month 6.'}], 'classes': [{'title': 'Tenderness/Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Mild', 'measurements': [{'value': '17', 'groupId': 'OG000'}]}, {'title': 'Moderate', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': 'Severe', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Swelling', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Mild', 'measurements': [{'value': '17', 'groupId': 'OG000'}]}, {'title': 'Moderate', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Severe', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Lumps/Bumps', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Mild', 'measurements': [{'value': '7', 'groupId': 'OG000'}]}, {'title': 'Moderate', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Severe', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Bruising', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Mild', 'measurements': [{'value': '8', 'groupId': 'OG000'}]}, {'title': 'Moderate', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Severe', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Redness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Mild', 'measurements': [{'value': '7', 'groupId': 'OG000'}]}, {'title': 'Moderate', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Severe', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Itching', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Mild', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': 'Moderate', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Severe', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Headache', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Mild', 'measurements': [{'value': '7', 'groupId': 'OG000'}]}, {'title': 'Moderate', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': 'Severe', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Jaw Pain/Tension', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Mild', 'measurements': [{'value': '7', 'groupId': 'OG000'}]}, {'title': 'Moderate', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}, {'title': 'Severe', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 14', 'description': 'Site treatment response reported by subject on diary day 0-14 post initial injection and touch-up injections', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Total number of subjects that reported symptom'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'JUVÉDERM VOLUMA™ XC', 'description': 'Subjects will be injected with JUVÉDERM VOLUMA™ XC to their right and left facial temporal regions at the baseline visit.\n\nJUVÉDERM VOLUMA™ XC: Subjects will receive up to 4, 1mL syringes of JUVÉDERM VOLUMA™ XC for their initial injection and a maximum of 6, 1mL syringes of JUVÉDERM VOLUMA™ XC for the study. Subjects will undergo one touch-up injection approximately 2 weeks post initial treatment, and will continue to be evaluated at month 1, month 3, and month 6.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'JUVÉDERM VOLUMA™ XC', 'description': 'Subjects will be injected with JUVÉDERM VOLUMA™ XC to their right and left facial temporal regions at the baseline visit.\n\nJUVÉDERM VOLUMA™ XC: Subjects will receive up to 4, 1mL syringes of JUVÉDERM VOLUMA™ XC for their initial injection and a maximum of 6, 1mL syringes of JUVÉDERM VOLUMA™ XC for the study. Subjects will undergo one touch-up injection approximately 2 weeks post initial treatment, and will continue to be evaluated at month 1, month 3, and month 6.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '26', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '28', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '18', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '30', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2015-08-07', 'size': 2202337, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2018-01-19T12:36', 'hasProtocol': True}, {'date': '2015-08-13', 'size': 1048604, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2018-01-19T12:36', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Open Label'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-08-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2017-04-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-01-19', 'studyFirstSubmitDate': '2015-04-30', 'resultsFirstSubmitDate': '2017-04-13', 'studyFirstSubmitQcDate': '2015-05-05', 'lastUpdatePostDateStruct': {'date': '2018-02-15', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-04-13', 'studyFirstPostDateStruct': {'date': '2015-05-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-05-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-04-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': "Subject's Satisfaction With Temple Appearance", 'timeFrame': 'Baseline, month 1, month 3, month 6, month 9, and Month 12', 'description': "Subject's Satisfaction with Temple Appearance"}, {'measure': 'Subject Self-Perception of Age', 'timeFrame': 'Baseline, month 1, month 3, month 6, month 9, and Month 12', 'description': 'Subjects perception of age when the subject looks at his/her right and left temples'}, {'measure': 'Number of Participants With Specific Site Treatment Responses', 'timeFrame': 'Day 14', 'description': 'Site treatment response reported by subject on diary day 0-14 post initial injection and touch-up injections'}], 'primaryOutcomes': [{'measure': 'Frontal Temporal Fossa Rating Scale', 'timeFrame': 'Baseline, Month 1, Month 3, Month 6, Month 9, and Month 12', 'description': 'Graded severity of the temporal line of the frontal bone (TLFB) using the Frontal Temporal Fossa Rating Scale: (these will have a picture assigned to each score.'}], 'secondaryOutcomes': [{'measure': "Investigator's Satisfaction With the Appearance of the Temporal Regions", 'timeFrame': 'Baseline, Month 1, Month 3, Month 6, Month 9, and Month 12', 'description': "Graded level of satisfaction with the current appearance of the temporal region making certain that the investigator is looking at the patient's right side and not the investigator's right side."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['voluma temporal, facial, volume loss'], 'conditions': ['Aging']}, 'descriptionModule': {'briefSummary': "This study is to determine the efficacy and safety of JUVÉDERM VOLUMA™ XC when used in the facial temporal regions based on the change in the score of the investigator's Temporal. This study will be an open label, single center study.", 'detailedDescription': 'Volume deficit in the temporal area (the side of the forehead) of the face is a common sign of aging.\n\nJUVÉDERM VOLUMA™ XC is a dermal filler, which was FDA-approved in October 2013 for the improvement and correction of age-related volume deficit in the mid-face area.\n\nJUVÉDERM VOLUMA™ XC is a gel implant composed of 20 mg/mL hyaluronic acid (HA) formulation, produced by Streptococcus equi bacteria, and 0.3 w/w lidocaine. JUVÉDERM VOLUMA™ XC is a clear, sterile, and biodegradable gel indicated for subcutaneous and/or supraperiosteal injection.\n\nJUVÉDERM VOLUMA™ XCwill be injected in the temple area and subjects will be followed for 12 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '35 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Willing and able to read and sign the informed consent and other study documents.\n* Treating investigator's score of 3, 4, or 5 on the Temporal Fossa Rating Scale.\n* Written informed consent has been obtained prior to any study-related procedures.\n* Written Authorization for Use and Release of Health and Research Study Information has been signed.\n* Ability to follow study instructions and complete study assessment tools including the subject diary\n* Female patients of childbearing potential must have a negative urine pregnancy test result and not be lactating.\n* Likely to complete all required visits with no plans to move from Miami in the next 12 months\n* Agree to not undergo other treatments or cosmetic procedures in the treatment area during the study such as facial laser treatments, botulinum toxin, hyaluronic acid injections, subcutaneous fat injections, any other permanent or semi-permanent facial fillers.\n\nExclusion Criteria:\n\n* Any uncontrolled systemic disease\n* History of any of the following conditions: vision loss not corrected by lenses or LASIX surgery; glaucoma, retinal detachment, macular degeneration, history of multiple sclerosis or optic neuritis, or any uncontrolled eye disease.\n* Have a history of severe allergic/anaphylactic reactions or multiple allergies.\n* Conditions within the treatment area including acne, scarring, acute lupus erythematosus, dermatitis, or melasma.\n* Females planning to become pregnant, are pregnant, or are breast-feeding.\n* History or current evidence of drug or alcohol abuse within 12 months prior to the screening visit\n* Have severe thin skin, in the treatment area as determined by the PI.\n* Have undergone temporary facial dermal filler injections with hyaluronic acid-based fillers within 12 months in the treatment area. Have had neuromodulator injections, mesotherapy, or resurfacing (laser or other ablative or non-ablative procedures) within 5 months prior to entry in the study or be planning to undergo any of these procedures at any time during the study.\n* Have undergone facial plastic surgery (with the exception of rhinoplasty or a brow lift), tissue grafting, or tissue augmentation with silicone, fat, or other permanent or semi-permanent dermal fillers or be planning to undergo any of these procedures affecting the treatment area, at any time during the study.\n* Unwilling to undergo injections in the temple area.\n* Have a history of migraines or frequent headaches, as determined by the PI.\n* Have blindness or partial vision loss in either eye.\n* Have received any other therapy, which, in the opinion of the investigator, could interfere with safety or efficacy evaluations.\n* Current enrollment in an investigational drug or device study or participation in such a study within 30 days of entry into this study.\n* Patient who has a condition or is in a situation that, in the investigator's opinion, may put the patient at significant risk, or may significantly interfere with the patient's participation in the study.\n* Have received anti-coagulation, anti-platelet, or thrombolytic medications (e.g.,warfarin), anti-inflammatory drugs (NSAIDs, e.g., aspirin, ibuprofen), or other substances known to increase coagulation time from 10 days pre- to 3 days post injection. A wash out period of 10 days is allowed.\n* Have undergone immunosuppressive therapy, chemotherapy, biologics or systemic corticosteroids within 3 months prior to each study visit."}, 'identificationModule': {'nctId': 'NCT02437903', 'briefTitle': 'Open Label Study Evaluating the Efficacy and Safety of JUVÉDERM VOLUMA™ XC for the Facial Temporal Regions', 'organization': {'class': 'OTHER', 'fullName': 'Baumann Cosmetic and Research Institute'}, 'officialTitle': 'Open Label, Single-center Study, Evaluating the Efficacy and Safety of JUVÉDERM VOLUMA™ XC for the Facial Temporal Regions', 'orgStudyIdInfo': {'id': 'Voluma Temporal 2014'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'JUVÉDERM VOLUMA™ XC', 'description': 'Subjects will be injected with JUVÉDERM VOLUMA™ XC to their right and left facial temporal regions at the baseline visit.', 'interventionNames': ['Device: JUVÉDERM VOLUMA™ XC']}], 'interventions': [{'name': 'JUVÉDERM VOLUMA™ XC', 'type': 'DEVICE', 'otherNames': ['Injectable Dermal Filler'], 'description': 'Subjects will receive up to 4, 1mL syringes of JUVÉDERM VOLUMA™ XC for their initial injection and a maximum of 6, 1mL syringes of JUVÉDERM VOLUMA™ XC for the study. Subjects will undergo one touch-up injection approximately 2 weeks post initial treatment, and will continue to be evaluated at month 1, month 3, month 6, month 9, and month 12.', 'armGroupLabels': ['JUVÉDERM VOLUMA™ XC']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33137', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Baumann Cosmetic and Research Institute', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}], 'overallOfficials': [{'name': 'Leslie S Baumann, MD,CPI', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Baumann Cosmetic and Research Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Baumann Cosmetic and Research Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}