Ignite Creation Date:
2025-12-24 @ 3:40 PM
Ignite Modification Date:
2026-02-24 @ 3:52 AM
Study NCT ID:
NCT04124692
Status:
COMPLETED
Last Update Posted:
2023-11-18
First Post:
2019-10-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety and Effectiveness of Sculptra Aesthetic for Correction of Cheek Wrinkles
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2023-11-02', 'type': 'ACTUAL'}}}}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'reception.seupp@galderma.com', 'phone': '+46184749000', 'title': 'Head of Development', 'organization': 'Q-Med AB'}, 'certainAgreement': {'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From start of study drug administration up to end of the study (up to Month 12)', 'description': 'SP included all participants who were treated with Sculptra Aesthetic or randomized to the no treatment control group.', 'eventGroups': [{'id': 'EG000', 'title': 'Control Group: No-treatment', 'description': 'Participants were injected with Sculptra Aesthetic by treating investigator at Day 1 until optimal correction achieved.', 'otherNumAtRisk': 52, 'deathsNumAtRisk': 52, 'otherNumAffected': 0, 'seriousNumAtRisk': 52, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Treatment Group: Sculptra Aesthetic', 'description': 'Participants were injected with Sculptra Aesthetic by treating investigator at Day 1 until optimal correction achieved.', 'otherNumAtRisk': 97, 'deathsNumAtRisk': 97, 'otherNumAffected': 11, 'seriousNumAtRisk': 97, 'deathsNumAffected': 0, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Injection site bruising', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 97, 'numAffected': 11}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1.'}], 'seriousEvents': [{'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 97, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1.'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 97, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1.'}, {'term': 'Obstruction gastric and small intestine adenocarcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 97, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1.'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': "Responder Rate Based on the Blinded Evaluator's Live Assessment of the Galderma Cheek Wrinkles Scale (GCWS) at Rest at Month 12", 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Group: No-treatment', 'description': 'Participants received no treatment during the study.'}, {'id': 'OG001', 'title': 'Treatment Group: Sculptra Aesthetic', 'description': 'Participants were injected with Sculptra Aesthetic by treating investigator at Day 1 until optimal correction achieved (up to 4 total treatment sessions).'}], 'classes': [{'categories': [{'measurements': [{'value': '26.1', 'groupId': 'OG000'}, {'value': '71.6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'At Month 12', 'description': 'Responder rate was defined as the percentage of participants with at least a 1-grade improvement from baseline on the GCWS, on both sides of the face, concurrently. GCWS is a validated 5-point scale used to assess the severity of cheek wrinkles: 0 (none \\[no lines or wrinkles\\]), 1 (mild \\[only few superficial lines\\]), 2 (moderate \\[many superficial lines or a few shallow wrinkles\\]), 3 (severe \\[many shallow wrinkles or a few moderate depth wrinkles\\]) and 4 (very severe \\[many moderate wrinkles or at least one depth wrinkle with or without redundant folds\\]). Higher score means more severe (worse) wrinkles. The participant was to have a relaxed face during the assessment.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all participants who were randomized based on the treatment they were randomized to. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': "Responder Rate Based on the Blinded Evaluator's Live Assessment of the GCWS at Rest at Months 7 and 9", 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Group: No-treatment', 'description': 'Participants received no treatment during the study.'}, {'id': 'OG001', 'title': 'Treatment Group: Sculptra Aesthetic', 'description': 'Participants were injected with Sculptra Aesthetic by treating investigator at Day 1 until optimal correction achieved (up to 4 total treatment sessions).'}], 'classes': [{'title': 'Month 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '38.6', 'groupId': 'OG000'}, {'value': '66.2', 'groupId': 'OG001'}]}]}, {'title': 'Month 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '31.1', 'groupId': 'OG000'}, {'value': '70.6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '= 0.0043', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'At Months 7 and 9', 'description': 'Responder rate was defined as the percentage of participants with at least a 1-grade improvement from baseline on the GCWS, on both sides of the face, concurrently. GCWS is a validated 5-point scale used to assess the severity of cheek wrinkles: 0 (none \\[no lines or wrinkles\\]), 1 (mild \\[only few superficial lines\\]), 2 (moderate \\[many superficial lines or a few shallow wrinkles\\]), 3 (severe \\[many shallow wrinkles or a few moderate depth wrinkles\\]) and 4 (very severe \\[many moderate wrinkles or at least one depth wrinkle with or without redundant folds\\]). Higher score means more severe (worse) wrinkles. The participant was to have a relaxed face during the assessment.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all participants who were randomized based on the treatment they were randomized to. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure and "number analyzed" signifies those participants who were evaluable at the specified timepoints.'}, {'type': 'SECONDARY', 'title': "Responder Rate Based on the Blinded Evaluator's Live Assessment of the GCWS Dynamic at Months 7, 9 and 12", 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Group: No-treatment', 'description': 'Participants received no treatment during the study.'}, {'id': 'OG001', 'title': 'Treatment Group: Sculptra Aesthetic', 'description': 'Participants were injected with Sculptra Aesthetic by treating investigator at Day 1 until optimal correction achieved (up to 4 total treatment sessions).'}], 'classes': [{'title': 'Month 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '27.3', 'groupId': 'OG000'}, {'value': '67.5', 'groupId': 'OG001'}]}]}, {'title': 'Month 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '22.2', 'groupId': 'OG000'}, {'value': '64.7', 'groupId': 'OG001'}]}]}, {'title': 'Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '28.3', 'groupId': 'OG000'}, {'value': '70.5', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Months 7, 9, and 12', 'description': 'Responder rate was defined as the percentage of participants with at least a 1-grade improvement from baseline on the GCWS, on both sides of the face, concurrently. GCWS is a validated 5-point scale used to assess the severity of cheek wrinkles: 0 (none \\[no lines or wrinkles\\]), 1 (mild \\[only few superficial lines\\]), 2 (moderate \\[many superficial lines or a few shallow wrinkles\\]), 3 (severe \\[many shallow wrinkles or a few moderate depth wrinkles\\]) and 4 (very severe \\[many moderate wrinkles or at least one depth wrinkle with or without redundant folds\\]). Higher score means more severe (worse) wrinkles. The participant was to have a closed maximum smile during the assessment.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all participants who were randomized based on the treatment they were randomized to. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure and "number analyzed" signifies those participants who were evaluable at the specified timepoints.'}, {'type': 'SECONDARY', 'title': "Percentage of Participants With Improvement Rate Based on the Independent Photographic Reviewer's Assessment", 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Group: No-treatment', 'description': 'Participants in this group received no treatment during the study.'}, {'id': 'OG001', 'title': 'Treatment Group: Sculptra Aesthetic', 'description': 'Participants were injected with Sculptra Aesthetic by treating investigator at Day 1 until optimal correction achieved (up to 4 total treatment sessions).'}], 'classes': [{'title': 'Left Cheek', 'categories': [{'measurements': [{'value': '29.5', 'groupId': 'OG000'}, {'value': '53.6', 'groupId': 'OG001'}]}]}, {'title': 'Right Cheek', 'categories': [{'measurements': [{'value': '34.1', 'groupId': 'OG000'}, {'value': '57.1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Month 12', 'description': "Improvement rate based on the Independent Photographic Reviewer's assessment using random pairings of baseline and Month 12 photographs was done.\n\nAn improved subject is defined as a subject for whom the Independent Photographic Reviewer identified the month 12 photograph in the pair as post-treatment.", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all participants who were randomized based on the treatment they were randomized to. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure and "number analyzed" signifies those participants who were evaluable at the specified timepoints.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With At Least "Improved" on the Global Aesthetic Improvement Scale (GAIS) Based on the Participants Live Assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Group: No-treatment', 'description': 'Participants received no treatment during the study.'}, {'id': 'OG001', 'title': 'Treatment Group: Sculptra Aesthetic', 'description': 'Participants were injected with Sculptra Aesthetic by treating investigator at Day 1 until optimal correction achieved (up to 4 total treatment sessions).'}], 'classes': [{'title': 'Month 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.0', 'groupId': 'OG000', 'lowerLimit': '1.5', 'upperLimit': '19.1'}, {'value': '93.5', 'groupId': 'OG001', 'lowerLimit': '85.5', 'upperLimit': '97.9'}]}]}, {'title': 'Month 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.8', 'groupId': 'OG000', 'lowerLimit': '1.4', 'upperLimit': '18.7'}, {'value': '89.4', 'groupId': 'OG001', 'lowerLimit': '80.9', 'upperLimit': '95.0'}]}]}, {'title': 'Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.5', 'groupId': 'OG000', 'lowerLimit': '1.4', 'upperLimit': '17.9'}, {'value': '92.0', 'groupId': 'OG001', 'lowerLimit': '84.3', 'upperLimit': '96.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Months 7, 9, and 12', 'description': 'GAIS responder rates are based on independent assessments by the participant. Responder rate was defined as the percentage of participants with at least "Improved" when compared to baseline before first treatment. The 7-graded GAIS was used by the participant to live assess the aesthetic improvement of the cheek wrinkles by responding to the question: "How would you describe the aesthetic improvement today compared to the photograph taken before treatment?" by using the respective categorical scale as follows; Very Much Improved, Much Improved, Improved, No Change, Worse, Much Worse, Very Much Worse.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all participants who were randomized based on the treatment they were randomized to. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure and "number analyzed" signifies those participants who were evaluable at the specified timepoints.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With At Least "Improved" on the GAIS Based on the Investigator Live Assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Group: No-treatment', 'description': 'Participants received no treatment during the study.'}, {'id': 'OG001', 'title': 'Treatment Group: Sculptra Aesthetic', 'description': 'Participants were injected with Sculptra Aesthetic by treating investigator at Day 1 until optimal correction achieved (up to 4 total treatment sessions).'}], 'classes': [{'title': 'Month 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.8', 'groupId': 'OG000', 'lowerLimit': '1.4', 'upperLimit': '18.7'}, {'value': '96.1', 'groupId': 'OG001', 'lowerLimit': '89.0', 'upperLimit': '99.2'}]}]}, {'title': 'Month 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.4', 'groupId': 'OG000', 'lowerLimit': '0.5', 'upperLimit': '15.2'}, {'value': '92.9', 'groupId': 'OG001', 'lowerLimit': '85.3', 'upperLimit': '97.4'}]}]}, {'title': 'Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.3', 'groupId': 'OG000', 'lowerLimit': '0.5', 'upperLimit': '14.8'}, {'value': '94.3', 'groupId': 'OG001', 'lowerLimit': '87.2', 'upperLimit': '98.1'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Months 7, 9, and 12', 'description': 'GAIS responder rates are based on independent assessments by the investigator. Responder rate was defined as the percentage of participants with at least "Improved" when compared to baseline before first treatment. The 7-graded GAIS was used by the investigator to live assess the aesthetic improvement of the cheek wrinkles by responding to the question: "How would you describe the aesthetic improvement today compared to the photograph taken before treatment?" by using the respective categorical scale as follows; Very Much Improved, Much Improved, Improved, No Change, Worse, Much Worse, Very Much Worse.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all participants who were randomized based on the treatment they were randomized to. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure and "number analyzed" signifies those participants who were evaluable at the specified timepoints.'}, {'type': 'SECONDARY', 'title': 'Satisfaction With Treatment: Does the Treatment Make You Look Younger?', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Group: Sculptra Aesthetic', 'description': 'Participants were injected with Sculptra Aesthetic by treating investigator at Day 1 until optimal correction achieved (up to 4 total treatment sessions).'}], 'classes': [{'title': 'At Month 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Excellent', 'measurements': [{'value': '13', 'groupId': 'OG000'}]}, {'title': 'Very good', 'measurements': [{'value': '24', 'groupId': 'OG000'}]}, {'title': 'Good', 'measurements': [{'value': '15', 'groupId': 'OG000'}]}, {'title': 'Satisfactory', 'measurements': [{'value': '19', 'groupId': 'OG000'}]}, {'title': 'Not satisfied', 'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'At Month 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Excellent', 'measurements': [{'value': '19', 'groupId': 'OG000'}]}, {'title': 'Very good', 'measurements': [{'value': '26', 'groupId': 'OG000'}]}, {'title': 'Good', 'measurements': [{'value': '18', 'groupId': 'OG000'}]}, {'title': 'Satisfactory', 'measurements': [{'value': '15', 'groupId': 'OG000'}]}, {'title': 'Not satisfied', 'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'At Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Excellent', 'measurements': [{'value': '15', 'groupId': 'OG000'}]}, {'title': 'Very good', 'measurements': [{'value': '29', 'groupId': 'OG000'}]}, {'title': 'Good', 'measurements': [{'value': '24', 'groupId': 'OG000'}]}, {'title': 'Satisfactory', 'measurements': [{'value': '11', 'groupId': 'OG000'}]}, {'title': 'Not satisfied', 'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Months 7, 9, and 12', 'description': 'A 5-point subject satisfaction questionnaire with the following responses: Excellent, Very good, Good, Satisfactory, Not satisfied.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all participants who were randomized based on the treatment they were randomized to. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure and "number analyzed" refer to participants evaluable for this outcome at given timepoints. The data was planned to be collected and analyzed for treatment group only.'}, {'type': 'SECONDARY', 'title': 'Satisfaction With Treatment: Does the Treatment Make You Feel Better About Yourself?', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Group: Sculptra Aesthetic', 'description': 'Participants were injected with Sculptra Aesthetic by treating investigator at Day 1 until optimal correction achieved (up to 4 total treatment sessions).'}], 'classes': [{'title': 'At Month 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Excellent', 'measurements': [{'value': '18', 'groupId': 'OG000'}]}, {'title': 'Very Good', 'measurements': [{'value': '20', 'groupId': 'OG000'}]}, {'title': 'Good', 'measurements': [{'value': '17', 'groupId': 'OG000'}]}, {'title': 'Satisfactory', 'measurements': [{'value': '18', 'groupId': 'OG000'}]}, {'title': 'Not Satisfied', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'At Month 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Excellent', 'measurements': [{'value': '18', 'groupId': 'OG000'}]}, {'title': 'Very Good', 'measurements': [{'value': '28', 'groupId': 'OG000'}]}, {'title': 'Good', 'measurements': [{'value': '22', 'groupId': 'OG000'}]}, {'title': 'Satisfactory', 'measurements': [{'value': '10', 'groupId': 'OG000'}]}, {'title': 'Not Satisfied', 'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'At Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Excellent', 'measurements': [{'value': '21', 'groupId': 'OG000'}]}, {'title': 'Very Good', 'measurements': [{'value': '23', 'groupId': 'OG000'}]}, {'title': 'Good', 'measurements': [{'value': '27', 'groupId': 'OG000'}]}, {'title': 'Satisfactory', 'measurements': [{'value': '11', 'groupId': 'OG000'}]}, {'title': 'Not Satisfied', 'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Months 7, 9, and 12', 'description': 'A 5-point subject satisfaction questionnaire with the following responses: Excellent, Very good, Good, Satisfactory, Not satisfied.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all participants who were randomized based on the treatment they were randomized to. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure and "number analyzed" refer to participants evaluable for this outcome at given timepoints. The data was planned to be collected and analyzed for treatment group only.'}, {'type': 'SECONDARY', 'title': 'Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence?', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Group: Sculptra Aesthetic', 'description': 'Participants were injected with Sculptra Aesthetic by treating investigator at Day 1 until optimal correction achieved (up to 4 total treatment sessions).'}], 'classes': [{'title': 'At Month 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Excellent', 'measurements': [{'value': '14', 'groupId': 'OG000'}]}, {'title': 'Very good', 'measurements': [{'value': '24', 'groupId': 'OG000'}]}, {'title': 'Good', 'measurements': [{'value': '16', 'groupId': 'OG000'}]}, {'title': 'Satisfactory', 'measurements': [{'value': '18', 'groupId': 'OG000'}]}, {'title': 'Not Satisfied', 'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'At Month 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Excellent', 'measurements': [{'value': '18', 'groupId': 'OG000'}]}, {'title': 'Very good', 'measurements': [{'value': '25', 'groupId': 'OG000'}]}, {'title': 'Good', 'measurements': [{'value': '25', 'groupId': 'OG000'}]}, {'title': 'Satisfactory', 'measurements': [{'value': '9', 'groupId': 'OG000'}]}, {'title': 'Not Satisfied', 'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': 'At Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Excellent', 'measurements': [{'value': '20', 'groupId': 'OG000'}]}, {'title': 'Very good', 'measurements': [{'value': '21', 'groupId': 'OG000'}]}, {'title': 'Good', 'measurements': [{'value': '30', 'groupId': 'OG000'}]}, {'title': 'Satisfactory', 'measurements': [{'value': '10', 'groupId': 'OG000'}]}, {'title': 'Not Satisfied', 'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Months 7, 9, and 12', 'description': 'A 5-point subject satisfaction questionnaire with the following responses: Excellent, Very good, Good, Satisfactory, Not satisfied.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all participants who were randomized based on the treatment they were randomized to. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure and "number analyzed" refer to participants evaluable for this outcome at given timepoints. The data was planned to be collected and analyzed for treatment group only.'}, {'type': 'SECONDARY', 'title': 'Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance?', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Group: Sculptra Aesthetic', 'description': 'Participants were injected with Sculptra Aesthetic by treating investigator at Day 1 until optimal correction achieved (up to 4 total treatment sessions).'}], 'classes': [{'title': 'At Month 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Excellent', 'measurements': [{'value': '17', 'groupId': 'OG000'}]}, {'title': 'Very Good', 'measurements': [{'value': '23', 'groupId': 'OG000'}]}, {'title': 'Good', 'measurements': [{'value': '13', 'groupId': 'OG000'}]}, {'title': 'Satisfactory', 'measurements': [{'value': '19', 'groupId': 'OG000'}]}, {'title': 'Not Satisfied', 'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'At Month 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Excellent', 'measurements': [{'value': '19', 'groupId': 'OG000'}]}, {'title': 'Very Good', 'measurements': [{'value': '28', 'groupId': 'OG000'}]}, {'title': 'Good', 'measurements': [{'value': '18', 'groupId': 'OG000'}]}, {'title': 'Satisfactory', 'measurements': [{'value': '13', 'groupId': 'OG000'}]}, {'title': 'Not Satisfied', 'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'At Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Excellent', 'measurements': [{'value': '20', 'groupId': 'OG000'}]}, {'title': 'Very Good', 'measurements': [{'value': '21', 'groupId': 'OG000'}]}, {'title': 'Good', 'measurements': [{'value': '27', 'groupId': 'OG000'}]}, {'title': 'Satisfactory', 'measurements': [{'value': '13', 'groupId': 'OG000'}]}, {'title': 'Not Satisfied', 'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Months 7, 9, and 12', 'description': 'A 5-point subject satisfaction questionnaire with the following responses: Excellent, Very good, Good, Satisfactory, Not satisfied.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all participants who were randomized based on the treatment they were randomized to. 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The data was planned to be collected and analyzed for treatment group only.'}, {'type': 'SECONDARY', 'title': 'Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel?', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Group: Sculptra Aesthetic', 'description': 'Participants were injected with Sculptra Aesthetic by treating investigator at Day 1 until optimal correction achieved (up to 4 total treatment sessions).'}], 'classes': [{'title': 'At Month 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Excellent', 'measurements': [{'value': '18', 'groupId': 'OG000'}]}, {'title': 'Very good', 'measurements': [{'value': '19', 'groupId': 'OG000'}]}, {'title': 'Good', 'measurements': [{'value': '12', 'groupId': 'OG000'}]}, {'title': 'Satisfactory', 'measurements': [{'value': '18', 'groupId': 'OG000'}]}, {'title': 'Not Satisfied', 'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}, {'title': 'At Month 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Excellent', 'measurements': [{'value': '21', 'groupId': 'OG000'}]}, {'title': 'Very good', 'measurements': [{'value': '22', 'groupId': 'OG000'}]}, {'title': 'Good', 'measurements': [{'value': '22', 'groupId': 'OG000'}]}, {'title': 'Satisfactory', 'measurements': [{'value': '14', 'groupId': 'OG000'}]}, {'title': 'Not Satisfied', 'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'At Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Excellent', 'measurements': [{'value': '19', 'groupId': 'OG000'}]}, {'title': 'Very good', 'measurements': [{'value': '20', 'groupId': 'OG000'}]}, {'title': 'Good', 'measurements': [{'value': '25', 'groupId': 'OG000'}]}, {'title': 'Satisfactory', 'measurements': [{'value': '17', 'groupId': 'OG000'}]}, {'title': 'Not Satisfied', 'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Months 7, 9, and 12', 'description': 'A 5-point subject satisfaction questionnaire with the following responses: Excellent, Very good, Good, Satisfactory, Not satisfied.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all participants who were randomized based on the treatment they were randomized to. 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The data was planned to be collected and analyzed for treatment group only.'}, {'type': 'SECONDARY', 'title': 'Satisfaction With Treatment: Does the Treatment Improve Your Skin Firmness?', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Group: Sculptra Aesthetic', 'description': 'Participants were injected with Sculptra Aesthetic by treating investigator at Day 1 until optimal correction achieved (up to 4 total treatment sessions).'}], 'classes': [{'title': 'At Month 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Excellent', 'measurements': [{'value': '18', 'groupId': 'OG000'}]}, {'title': 'Very good', 'measurements': [{'value': '24', 'groupId': 'OG000'}]}, {'title': 'Good', 'measurements': [{'value': '17', 'groupId': 'OG000'}]}, {'title': 'Satisfactory', 'measurements': [{'value': '13', 'groupId': 'OG000'}]}, {'title': 'Not Satisfied', 'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'At Month 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Excellent', 'measurements': [{'value': '25', 'groupId': 'OG000'}]}, {'title': 'Very good', 'measurements': [{'value': '26', 'groupId': 'OG000'}]}, {'title': 'Good', 'measurements': [{'value': '16', 'groupId': 'OG000'}]}, {'title': 'Satisfactory', 'measurements': [{'value': '11', 'groupId': 'OG000'}]}, {'title': 'Not Satisfied', 'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'At Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Excellent', 'measurements': [{'value': '21', 'groupId': 'OG000'}]}, {'title': 'Very good', 'measurements': [{'value': '25', 'groupId': 'OG000'}]}, {'title': 'Good', 'measurements': [{'value': '26', 'groupId': 'OG000'}]}, {'title': 'Satisfactory', 'measurements': [{'value': '11', 'groupId': 'OG000'}]}, {'title': 'Not Satisfied', 'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Months 7, 9, and 12', 'description': 'A 5-point subject satisfaction questionnaire with the following responses: Excellent, Very good, Good, Satisfactory, Not satisfied.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all participants who were randomized based on the treatment they were randomized to. 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The data was planned to be collected and analyzed for treatment group only.'}, {'type': 'SECONDARY', 'title': 'Satisfaction With Treatment: Does the Treatment Improve Your Skin Radiance?', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Group: Sculptra Aesthetic', 'description': 'Participants were injected with Sculptra Aesthetic by treating investigator at Day 1 until optimal correction achieved (up to 4 total treatment sessions).'}], 'classes': [{'title': 'At Month 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Excellent', 'measurements': [{'value': '21', 'groupId': 'OG000'}]}, {'title': 'Very good', 'measurements': [{'value': '19', 'groupId': 'OG000'}]}, {'title': 'Good', 'measurements': [{'value': '13', 'groupId': 'OG000'}]}, {'title': 'Satisfactory', 'measurements': [{'value': '19', 'groupId': 'OG000'}]}, {'title': 'Not Satisfied', 'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'At Month 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Excellent', 'measurements': [{'value': '23', 'groupId': 'OG000'}]}, {'title': 'Very good', 'measurements': [{'value': '26', 'groupId': 'OG000'}]}, {'title': 'Good', 'measurements': [{'value': '13', 'groupId': 'OG000'}]}, {'title': 'Satisfactory', 'measurements': [{'value': '17', 'groupId': 'OG000'}]}, {'title': 'Not Satisfied', 'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'At Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Excellent', 'measurements': [{'value': '22', 'groupId': 'OG000'}]}, {'title': 'Very good', 'measurements': [{'value': '23', 'groupId': 'OG000'}]}, {'title': 'Good', 'measurements': [{'value': '24', 'groupId': 'OG000'}]}, {'title': 'Satisfactory', 'measurements': [{'value': '10', 'groupId': 'OG000'}]}, {'title': 'Not Satisfied', 'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Months 7, 9, and 12', 'description': 'A 5-point subject satisfaction questionnaire with the following responses: Excellent, Very good, Good, Satisfactory, Not satisfied.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all participants who were randomized based on the treatment they were randomized to. 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The data was planned to be collected and analyzed for treatment group only.'}, {'type': 'SECONDARY', 'title': 'Satisfaction With Treatment: Does the Treatment Improve Your Skin Sagging?', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Group: Sculptra Aesthetic', 'description': 'Participants were injected with Sculptra Aesthetic by treating investigator at Day 1 until optimal correction achieved (up to 4 total treatment sessions).'}], 'classes': [{'title': 'At Month 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Excellent', 'measurements': [{'value': '15', 'groupId': 'OG000'}]}, {'title': 'Very good', 'measurements': [{'value': '23', 'groupId': 'OG000'}]}, {'title': 'Good', 'measurements': [{'value': '20', 'groupId': 'OG000'}]}, {'title': 'Satisfactory', 'measurements': [{'value': '7', 'groupId': 'OG000'}]}, {'title': 'Not Satisfied', 'measurements': [{'value': '12', 'groupId': 'OG000'}]}]}, {'title': 'At Month 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Excellent', 'measurements': [{'value': '23', 'groupId': 'OG000'}]}, {'title': 'Very good', 'measurements': [{'value': '19', 'groupId': 'OG000'}]}, {'title': 'Good', 'measurements': [{'value': '24', 'groupId': 'OG000'}]}, {'title': 'Satisfactory', 'measurements': [{'value': '11', 'groupId': 'OG000'}]}, {'title': 'Not Satisfied', 'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': 'At Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Excellent', 'measurements': [{'value': '20', 'groupId': 'OG000'}]}, {'title': 'Very good', 'measurements': [{'value': '16', 'groupId': 'OG000'}]}, {'title': 'Good', 'measurements': [{'value': '32', 'groupId': 'OG000'}]}, {'title': 'Satisfactory', 'measurements': [{'value': '9', 'groupId': 'OG000'}]}, {'title': 'Not Satisfied', 'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Months 7, 9, and 12', 'description': 'A 5-point subject satisfaction questionnaire with the following responses: Excellent, Very good, Good, Satisfactory, Not satisfied.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all participants who were randomized based on the treatment they were randomized to. 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The data was planned to be collected and analyzed for treatment group only.'}, {'type': 'SECONDARY', 'title': 'Subject Satisfaction: Would You Say That the Treatment Results Are Natural Looking?', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Group: Sculptra Aesthetic', 'description': 'Participants were injected with Sculptra Aesthetic by treating investigator at Day 1 until optimal correction achieved (up to 4 total treatment sessions).'}], 'classes': [{'title': 'At Month 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Strongly agree', 'measurements': [{'value': '47', 'groupId': 'OG000'}]}, {'title': 'Agree', 'measurements': [{'value': '25', 'groupId': 'OG000'}]}, {'title': 'Neither Agree or Disagree', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}, {'title': 'Disagree', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Strongly Disagree', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'At Month 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Strongly agree', 'measurements': [{'value': '48', 'groupId': 'OG000'}]}, {'title': 'Agree', 'measurements': [{'value': '25', 'groupId': 'OG000'}]}, {'title': 'Neither Agree or Disagree', 'measurements': [{'value': '11', 'groupId': 'OG000'}]}, {'title': 'Disagree', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Strongly Disagree', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'At Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Strongly agree', 'measurements': [{'value': '47', 'groupId': 'OG000'}]}, {'title': 'Agree', 'measurements': [{'value': '30', 'groupId': 'OG000'}]}, {'title': 'Neither Agree or Disagree', 'measurements': [{'value': '7', 'groupId': 'OG000'}]}, {'title': 'Disagree', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'Strongly Disagree', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Months 7, 9, and 12', 'description': 'A 5-point subject satisfaction questionnaire with the following responses: Strongly agree, Agree, Neither agree or Disagree, Disagree, Strongly disagree.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all participants who were randomized based on the treatment they were randomized to. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure and "number analyzed" refer to participants evaluable for this outcome at given timepoints. The data was planned to be collected and analyzed for treatment group only.'}, {'type': 'SECONDARY', 'title': 'Subject Satisfaction: Would You Say the Subtle Changes Over Time Was Worth It?', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Group: Sculptra Aesthetic', 'description': 'Participants were injected with Sculptra Aesthetic by treating investigator at Day 1 until optimal correction achieved (up to 4 total treatment sessions).'}], 'classes': [{'title': 'At Month 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Strongly agree', 'measurements': [{'value': '36', 'groupId': 'OG000'}]}, {'title': 'Agree', 'measurements': [{'value': '27', 'groupId': 'OG000'}]}, {'title': 'Neither agree or Disagree', 'measurements': [{'value': '11', 'groupId': 'OG000'}]}, {'title': 'Disagree', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'Strongly disagree', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'At Month 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Strongly agree', 'measurements': [{'value': '41', 'groupId': 'OG000'}]}, {'title': 'Agree', 'measurements': [{'value': '27', 'groupId': 'OG000'}]}, {'title': 'Neither agree or Disagree', 'measurements': [{'value': '13', 'groupId': 'OG000'}]}, {'title': 'Disagree', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Strongly disagree', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'At Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Strongly agree', 'measurements': [{'value': '41', 'groupId': 'OG000'}]}, {'title': 'Agree', 'measurements': [{'value': '31', 'groupId': 'OG000'}]}, {'title': 'Neither agree or Disagree', 'measurements': [{'value': '12', 'groupId': 'OG000'}]}, {'title': 'Disagree', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'Strongly disagree', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Months 7, 9, and 12', 'description': 'A 5-point subject satisfaction questionnaire with the following responses: Strongly agree, Agree, Neither agree or Disagree, Disagree, Strongly disagree.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all participants who were randomized based on the treatment they were randomized to. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure and "number analyzed" refer to participants evaluable for this outcome at given timepoints. The data was planned to be collected and analyzed for treatment group only.'}, {'type': 'SECONDARY', 'title': 'Subject Satisfaction: Would You Recommend the Treatment to a Friend?', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Group: Sculptra Aesthetic', 'description': 'Participants were injected with Sculptra Aesthetic by treating investigator at Day 1 until optimal correction achieved (up to 4 total treatment sessions).'}], 'classes': [{'categories': [{'title': 'Yes', 'measurements': [{'value': '78', 'groupId': 'OG000'}]}, {'title': 'No', 'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Month 12', 'description': 'A subject satisfaction question with responses Yes or No.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all participants who were randomized based on the treatment they were randomized to. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure and "number analyzed" refer to participants evaluable for this outcome at given timepoints. The data was planned to be collected and analyzed for treatment group only.'}, {'type': 'SECONDARY', 'title': 'Subject Satisfaction: Would You do the Treatment Again?', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Group: Sculptra Aesthetic', 'description': 'Participants were injected with Sculptra Aesthetic by treating investigator at Day 1 until optimal correction achieved (up to 4 total treatment sessions).'}], 'classes': [{'categories': [{'title': 'Yes', 'measurements': [{'value': '76', 'groupId': 'OG000'}]}, {'title': 'No', 'measurements': [{'value': '12', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Month 12', 'description': 'A subject satisfaction question with responses Yes or No.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all participants who were randomized based on the treatment they were randomized to. Here, overall number of participants analyzed refer to the participants evaluated for this outcome measure and "number analyzed" refer to participants evaluable for this outcome at given timepoints. The data was planned to be collected and analyzed for treatment group only.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Satisfaction With Cheeks FACE-Q™ Questionnaire Rasch-transformed Total Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Group: No-treatment', 'description': 'Participants received no treatment during the study.'}, {'id': 'OG001', 'title': 'Treatment Group: Sculptra Aesthetic', 'description': 'Participants were injected with Sculptra Aesthetic by treating investigator at Day 1 until optimal correction achieved (up to 4 total treatment sessions).'}], 'classes': [{'title': 'At Month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '21.3', 'spread': '24.25', 'groupId': 'OG001'}]}]}, {'title': 'At Month 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '31.6', 'spread': '28.45', 'groupId': 'OG001'}]}]}, {'title': 'At Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '38.6', 'spread': '26.51', 'groupId': 'OG001'}]}]}, {'title': 'At Month 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-4.1', 'spread': '20.34', 'groupId': 'OG000'}, {'value': '38.6', 'spread': '26.30', 'groupId': 'OG001'}]}]}, {'title': 'At Month 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.6', 'spread': '21.36', 'groupId': 'OG000'}, {'value': '37.9', 'spread': '26.63', 'groupId': 'OG001'}]}]}, {'title': 'At Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.6', 'spread': '21.76', 'groupId': 'OG000'}, {'value': '40.0', 'spread': '29.07', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Treatment group: Baseline, Months 1, 2, 3, 7, 9 and 12; Control group: Baseline, Months 7, 9 and 12', 'description': 'The participant assessed satisfaction using the 5 questions on the FACE-Q: Satisfaction with Cheeks Appearance questionnaire measured on a 4-point scale where 1=very dissatisfied, 2=somewhat dissatisfied, 3=somewhat satisfied, and 4=very satisfied. The responses to the items were converted to a 100-point Rasch transformed total score with 0 (worst) to 100 (best). Higher scores indicate higher satisfaction. A negative change from baseline indicates less improvement.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all participants who were randomized based on the treatment they were randomized to. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure and "number analyzed" signifies those participants who were evaluable at the specified timepoints.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Group: No-treatment', 'description': 'Participants were injected with Sculptra Aesthetic by treating investigator at Day 1 until optimal correction achieved.'}, {'id': 'OG001', 'title': 'Treatment Group: Sculptra Aesthetic', 'description': 'Participants were injected with Sculptra Aesthetic by treating investigator at Day 1 until optimal correction achieved (up to 4 total treatment sessions).'}], 'classes': [{'title': 'Non-serious AE', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}]}, {'title': 'Serious AE', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From start of study drug administration up to end of the study (up to Month 12)', 'description': 'An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. TEAEs were defined as AEs with a start date on or after the first dose of investigational product or a start date before the date of the first dose of investigational product that increased in severity or after the date of the first dose. A SAE was any untoward medical occurrence (whether considered to be related to investigational product or not) that at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital abnormality/birth defect, and was an important medical event. TEAEs included both serious and non-serious TEAEs.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population (SP) included all participants who were treated with Sculptra Aesthetic or randomized to the no treatment control group.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Control Group: No-treatment', 'description': 'Participants received no treatment during the study.'}, {'id': 'FG001', 'title': 'Treatment Group: Sculptra Aesthetic', 'description': 'Participants were injected with Sculptra Aesthetic by treating investigator at Day 1 until optimal correction achieved (up to 4 total treatment sessions).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '52'}, {'groupId': 'FG001', 'numSubjects': '97'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '46'}, {'groupId': 'FG001', 'numSubjects': '88'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '9'}]}], 'dropWithdraws': [{'type': 'Medical reason', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal of informed consent (not due to coronavirus disease-19 concerns)', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal of informed consent (due to coronavirus disease-19 concerns)', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Screen failure due to previous use of Radiesse', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'The study was conducted at 13 sites at the United States from 12 November 2019 to12 August 2021.', 'preAssignmentDetails': 'A total of 149 participants were enrolled and randomized, of which 97 received treatment and 52 received no treatment in this study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'BG000'}, {'value': '97', 'groupId': 'BG001'}, {'value': '149', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Control Group: No-treatment', 'description': 'Participants received no treatment during the study.'}, {'id': 'BG001', 'title': 'Treatment Group: Sculptra Aesthetic', 'description': 'Participants were injected with Sculptra Aesthetic by treating investigator at Day 1 until optimal correction achieved (up to 4 total treatment sessions).'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '60.4', 'spread': '8.72', 'groupId': 'BG000'}, {'value': '60.9', 'spread': '8.50', 'groupId': 'BG001'}, {'value': '60.7', 'spread': '8.55', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '94', 'groupId': 'BG001'}, {'value': '144', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '47', 'groupId': 'BG000'}, {'value': '90', 'groupId': 'BG001'}, {'value': '137', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '47', 'groupId': 'BG000'}, {'value': '88', 'groupId': 'BG001'}, {'value': '135', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Fitzpatrick Skin Type score (FST)', 'classes': [{'categories': [{'title': 'FST I', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'FST II', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}]}, {'title': 'FST III', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '68', 'groupId': 'BG002'}]}, {'title': 'FST IV', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}, {'title': 'FST V', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': 'FST VI', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'FST I: white; very fair; red or blond hair; blue eyes; freckles. always burns, never tans.\n\nFST II: white; fair; red or blond hair; blue, hazel or green eyes. usually burns, tans with difficulty.\n\nFST III: cream white; fair with any eye or hair color; very common. sometimes mild burn, gradually tans.\n\nFST IV: brown; typical Mediterranean Caucasian skin. rarely burns, tans with ease.\n\nFST V: dark brown; Middle Eastern skin types. very rarely burns, tans very easily.\n\nFST VI: Skin color - black. Skin Characteristics - never burns, tans very easily.', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Intent to treat (ITT) population included all participants who were randomized based on the treatment they were randomized to.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-03-24', 'size': 4658162, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-10-12T17:46', 'hasProtocol': True}, {'date': '2021-08-30', 'size': 4180930, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-10-12T17:48', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 149}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-11-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'dispFirstSubmitDate': '2021-10-12', 'completionDateStruct': {'date': '2021-08-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-16', 'studyFirstSubmitDate': '2019-10-10', 'resultsFirstSubmitDate': '2023-10-12', 'studyFirstSubmitQcDate': '2019-10-10', 'dispFirstPostDateStruct': {'date': '2023-11-18', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2023-11-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-11-16', 'studyFirstPostDateStruct': {'date': '2019-10-11', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-11-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Responder Rate Based on the Blinded Evaluator's Live Assessment of the Galderma Cheek Wrinkles Scale (GCWS) at Rest at Month 12", 'timeFrame': 'At Month 12', 'description': 'Responder rate was defined as the percentage of participants with at least a 1-grade improvement from baseline on the GCWS, on both sides of the face, concurrently. GCWS is a validated 5-point scale used to assess the severity of cheek wrinkles: 0 (none \\[no lines or wrinkles\\]), 1 (mild \\[only few superficial lines\\]), 2 (moderate \\[many superficial lines or a few shallow wrinkles\\]), 3 (severe \\[many shallow wrinkles or a few moderate depth wrinkles\\]) and 4 (very severe \\[many moderate wrinkles or at least one depth wrinkle with or without redundant folds\\]). Higher score means more severe (worse) wrinkles. The participant was to have a relaxed face during the assessment.'}], 'secondaryOutcomes': [{'measure': "Responder Rate Based on the Blinded Evaluator's Live Assessment of the GCWS at Rest at Months 7 and 9", 'timeFrame': 'At Months 7 and 9', 'description': 'Responder rate was defined as the percentage of participants with at least a 1-grade improvement from baseline on the GCWS, on both sides of the face, concurrently. GCWS is a validated 5-point scale used to assess the severity of cheek wrinkles: 0 (none \\[no lines or wrinkles\\]), 1 (mild \\[only few superficial lines\\]), 2 (moderate \\[many superficial lines or a few shallow wrinkles\\]), 3 (severe \\[many shallow wrinkles or a few moderate depth wrinkles\\]) and 4 (very severe \\[many moderate wrinkles or at least one depth wrinkle with or without redundant folds\\]). Higher score means more severe (worse) wrinkles. The participant was to have a relaxed face during the assessment.'}, {'measure': "Responder Rate Based on the Blinded Evaluator's Live Assessment of the GCWS Dynamic at Months 7, 9 and 12", 'timeFrame': 'At Months 7, 9, and 12', 'description': 'Responder rate was defined as the percentage of participants with at least a 1-grade improvement from baseline on the GCWS, on both sides of the face, concurrently. GCWS is a validated 5-point scale used to assess the severity of cheek wrinkles: 0 (none \\[no lines or wrinkles\\]), 1 (mild \\[only few superficial lines\\]), 2 (moderate \\[many superficial lines or a few shallow wrinkles\\]), 3 (severe \\[many shallow wrinkles or a few moderate depth wrinkles\\]) and 4 (very severe \\[many moderate wrinkles or at least one depth wrinkle with or without redundant folds\\]). Higher score means more severe (worse) wrinkles. The participant was to have a closed maximum smile during the assessment.'}, {'measure': "Percentage of Participants With Improvement Rate Based on the Independent Photographic Reviewer's Assessment", 'timeFrame': 'At Month 12', 'description': "Improvement rate based on the Independent Photographic Reviewer's assessment using random pairings of baseline and Month 12 photographs was done.\n\nAn improved subject is defined as a subject for whom the Independent Photographic Reviewer identified the month 12 photograph in the pair as post-treatment."}, {'measure': 'Percentage of Participants With At Least "Improved" on the Global Aesthetic Improvement Scale (GAIS) Based on the Participants Live Assessment', 'timeFrame': 'At Months 7, 9, and 12', 'description': 'GAIS responder rates are based on independent assessments by the participant. Responder rate was defined as the percentage of participants with at least "Improved" when compared to baseline before first treatment. The 7-graded GAIS was used by the participant to live assess the aesthetic improvement of the cheek wrinkles by responding to the question: "How would you describe the aesthetic improvement today compared to the photograph taken before treatment?" by using the respective categorical scale as follows; Very Much Improved, Much Improved, Improved, No Change, Worse, Much Worse, Very Much Worse.'}, {'measure': 'Percentage of Participants With At Least "Improved" on the GAIS Based on the Investigator Live Assessment', 'timeFrame': 'At Months 7, 9, and 12', 'description': 'GAIS responder rates are based on independent assessments by the investigator. Responder rate was defined as the percentage of participants with at least "Improved" when compared to baseline before first treatment. The 7-graded GAIS was used by the investigator to live assess the aesthetic improvement of the cheek wrinkles by responding to the question: "How would you describe the aesthetic improvement today compared to the photograph taken before treatment?" by using the respective categorical scale as follows; Very Much Improved, Much Improved, Improved, No Change, Worse, Much Worse, Very Much Worse.'}, {'measure': 'Satisfaction With Treatment: Does the Treatment Make You Look Younger?', 'timeFrame': 'At Months 7, 9, and 12', 'description': 'A 5-point subject satisfaction questionnaire with the following responses: Excellent, Very good, Good, Satisfactory, Not satisfied.'}, {'measure': 'Satisfaction With Treatment: Does the Treatment Make You Feel Better About Yourself?', 'timeFrame': 'At Months 7, 9, and 12', 'description': 'A 5-point subject satisfaction questionnaire with the following responses: Excellent, Very good, Good, Satisfactory, Not satisfied.'}, {'measure': 'Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence?', 'timeFrame': 'At Months 7, 9, and 12', 'description': 'A 5-point subject satisfaction questionnaire with the following responses: Excellent, Very good, Good, Satisfactory, Not satisfied.'}, {'measure': 'Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance?', 'timeFrame': 'At Months 7, 9, and 12', 'description': 'A 5-point subject satisfaction questionnaire with the following responses: Excellent, Very good, Good, Satisfactory, Not satisfied.'}, {'measure': 'Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life?', 'timeFrame': 'At Months 7, 9, and 12', 'description': 'A 5-point subject satisfaction questionnaire with the following responses: Excellent, Very good, Good, Satisfactory, Not satisfied.'}, {'measure': 'Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel?', 'timeFrame': 'At Months 7, 9, and 12', 'description': 'A 5-point subject satisfaction questionnaire with the following responses: Excellent, Very good, Good, Satisfactory, Not satisfied.'}, {'measure': 'Satisfaction With Treatment: Does the Treatment Improve Your Skin Firmness?', 'timeFrame': 'At Months 7, 9, and 12', 'description': 'A 5-point subject satisfaction questionnaire with the following responses: Excellent, Very good, Good, Satisfactory, Not satisfied.'}, {'measure': 'Satisfaction With Treatment: Does the Treatment Improve Your Skin Radiance?', 'timeFrame': 'At Months 7, 9, and 12', 'description': 'A 5-point subject satisfaction questionnaire with the following responses: Excellent, Very good, Good, Satisfactory, Not satisfied.'}, {'measure': 'Satisfaction With Treatment: Does the Treatment Improve Your Skin Sagging?', 'timeFrame': 'At Months 7, 9, and 12', 'description': 'A 5-point subject satisfaction questionnaire with the following responses: Excellent, Very good, Good, Satisfactory, Not satisfied.'}, {'measure': 'Satisfaction With Treatment: Does the Treatment Make Your Skin Look More Refreshed?', 'timeFrame': 'At Months 7, 9, and 12', 'description': 'A 5-point subject satisfaction questionnaire with the following responses: Excellent, Very good, Good, Satisfactory, Not satisfied.'}, {'measure': 'Subject Satisfaction: Would You Say That the Treatment Results Are Natural Looking?', 'timeFrame': 'At Months 7, 9, and 12', 'description': 'A 5-point subject satisfaction questionnaire with the following responses: Strongly agree, Agree, Neither agree or Disagree, Disagree, Strongly disagree.'}, {'measure': 'Subject Satisfaction: Would You Say the Subtle Changes Over Time Was Worth It?', 'timeFrame': 'At Months 7, 9, and 12', 'description': 'A 5-point subject satisfaction questionnaire with the following responses: Strongly agree, Agree, Neither agree or Disagree, Disagree, Strongly disagree.'}, {'measure': 'Subject Satisfaction: Would You Recommend the Treatment to a Friend?', 'timeFrame': 'At Month 12', 'description': 'A subject satisfaction question with responses Yes or No.'}, {'measure': 'Subject Satisfaction: Would You do the Treatment Again?', 'timeFrame': 'At Month 12', 'description': 'A subject satisfaction question with responses Yes or No.'}, {'measure': 'Change From Baseline in Satisfaction With Cheeks FACE-Q™ Questionnaire Rasch-transformed Total Scores', 'timeFrame': 'Treatment group: Baseline, Months 1, 2, 3, 7, 9 and 12; Control group: Baseline, Months 7, 9 and 12', 'description': 'The participant assessed satisfaction using the 5 questions on the FACE-Q: Satisfaction with Cheeks Appearance questionnaire measured on a 4-point scale where 1=very dissatisfied, 2=somewhat dissatisfied, 3=somewhat satisfied, and 4=very satisfied. The responses to the items were converted to a 100-point Rasch transformed total score with 0 (worst) to 100 (best). Higher scores indicate higher satisfaction. A negative change from baseline indicates less improvement.'}, {'measure': 'Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs', 'timeFrame': 'From start of study drug administration up to end of the study (up to Month 12)', 'description': 'An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. TEAEs were defined as AEs with a start date on or after the first dose of investigational product or a start date before the date of the first dose of investigational product that increased in severity or after the date of the first dose. A SAE was any untoward medical occurrence (whether considered to be related to investigational product or not) that at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital abnormality/birth defect, and was an important medical event. TEAEs included both serious and non-serious TEAEs.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Cheek Wrinkles']}, 'referencesModule': {'references': [{'pmid': '39453400', 'type': 'DERIVED', 'citation': 'Fabi SG, Le JHTD, Prygova I, Brasater D. Midface Projection Using Biostimulatory Poly- l -Lactic Acid Injectable Implant: A Subgroup Analysis of the Cheek Wrinkle Trial. Dermatol Surg. 2024 Dec 1;50(12):1137-1142. doi: 10.1097/DSS.0000000000004434. Epub 2024 Oct 17.'}]}, 'descriptionModule': {'briefSummary': 'The study has been designed to evaluate the safety and effectiveness of Sculptra Aesthetic as a single regimen for correction of cheek wrinkles after changes in reconstitution and injection procedures compared to the approved label.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Intent to undergo correction of cheek wrinkles on both sides of the face and a Galderma Cheek Wrinkles Scale (GCWS) At Rest score of Moderate or Severe on EACH side of the face.\n\nExclusion Criteria:\n\n* Known/previous allergy or hypersensitivity to any of the Sculptra Aesthetic constituents.\n* Previous tissue augmenting therapy, contouring or revitalization treatment in the face, except the lips, with any of the following fillers prior to Baseline visit:\n\n 1. Collagen, Hyaluronic Acid - 12 months\n 2. Calcium Hydroxyapatite (CaHa), Poly L- Lactic Acid (PLLA) or permanent (nonbiodegradable)- Prohibited'}, 'identificationModule': {'nctId': 'NCT04124692', 'briefTitle': 'Safety and Effectiveness of Sculptra Aesthetic for Correction of Cheek Wrinkles', 'organization': {'class': 'INDUSTRY', 'fullName': 'Galderma R&D'}, 'officialTitle': 'A Randomized, Evaluator-blinded, No-treatment Controlled, Multicenter Study to Evaluate the Effectiveness and Safety of Sculptra Aesthetic for Correction of Cheek Wrinkles.', 'orgStudyIdInfo': {'id': '43USSA1812'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control Group: No-treatment', 'description': 'Participants will receive no treatment during the study.'}, {'type': 'EXPERIMENTAL', 'label': 'Treatment Group: Sculptra Aesthetic', 'description': 'Participants will be injected with Sculptra Aesthetic by Treating Investigator at Day 1 until optimal correction achieved (up to 4 total treatment sessions)', 'interventionNames': ['Device: Sculptra Aesthetic new dilution']}], 'interventions': [{'name': 'Sculptra Aesthetic new dilution', 'type': 'DEVICE', 'description': 'Treatment of cheek wrinkles', 'armGroupLabels': ['Treatment Group: Sculptra Aesthetic']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85255', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Galderma Research Site', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '91436', 'city': 'Encino', 'state': 'California', 'country': 'United States', 'facility': 'Galderma Research Site', 'geoPoint': {'lat': 34.15917, 'lon': -118.50119}}, {'zip': '90277', 'city': 'Redondo Beach', 'state': 'California', 'country': 'United States', 'facility': 'Galderma Research Site', 'geoPoint': {'lat': 33.84918, 'lon': -118.38841}}, {'zip': '92121', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Galderma Research Site', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '20037', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Galderma Research Site', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '33143', 'city': 'Coral Gables', 'state': 'Florida', 'country': 'United States', 'facility': 'Galderma Research Site', 'geoPoint': {'lat': 25.72149, 'lon': -80.26838}}, {'zip': '30022', 'city': 'Alpharetta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Galderma Research Site', 'geoPoint': {'lat': 34.07538, 'lon': -84.29409}}, {'zip': '70115', 'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Galderma Research Site', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'zip': '20852', 'city': 'Rockville', 'state': 'Maryland', 'country': 'United States', 'facility': 'Galderma Research Site', 'geoPoint': {'lat': 39.084, 'lon': -77.15276}}, {'zip': '10021', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Galderma Research Site', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10028', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Galderma Research Site', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '75254', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Galderma Research Site', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '77388', 'city': 'Spring', 'state': 'Texas', 'country': 'United States', 'facility': 'Galderma Research Site', 'geoPoint': {'lat': 30.07994, 'lon': -95.41716}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Galderma R&D', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}