Ignite Creation Date:
2025-12-24 @ 12:23 PM
Ignite Modification Date:
2025-12-27 @ 10:43 PM
Study NCT ID:
NCT05064761
Status:
COMPLETED
Last Update Posted:
2024-09-26
First Post:
2021-09-22
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety and Effectiveness of Poly-l-lactic Acid (PLLA) for the Improvement in Appearance of Cellulite
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000071697', 'term': 'Cellulite'}], 'ancestors': [{'id': 'D012877', 'term': 'Skin Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'aestheticclinicaltrials@galderma.com', 'phone': '+1 817-961-5000', 'title': 'Clinical Project Manager', 'organization': 'Galderma Research and Development, LLC (GLLC)'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Up to 12 months', 'eventGroups': [{'id': 'EG000', 'title': 'Treatment Group (Sculptra)', 'description': 'Participants with intent to undergo treatment to improve appearance of cellulite were enrolled and treated with Sculptra in three sessions spaced one month (+2 weeks) apart. Participants were treated at baseline, Month 1 and Month 2.', 'otherNumAtRisk': 29, 'deathsNumAtRisk': 29, 'otherNumAffected': 10, 'seriousNumAtRisk': 29, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Intervertebral disc protrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Urethral prolapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Aesthetic Improved Thighs of Responders According to Global Aesthetic Improvement Scale (GAIS) as Assessed Live by Treating Investigator at Month 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}, {'units': 'Thighs', 'counts': [{'value': '58', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Group (Sculptra)', 'description': 'Participants with intent to undergo treatment to improve appearance of cellulite were enrolled and treated with Sculptra in three sessions spaced one month (+2 weeks) apart. Participants were treated at baseline, Month 1 and Month 2.'}], 'classes': [{'title': 'Left thigh', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}, {'units': 'Thighs', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Very much improved', 'measurements': [{'value': '23', 'groupId': 'OG000'}]}, {'title': 'Much improved', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}, {'title': 'Improved', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'No change', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Right thigh', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}, {'units': 'Thighs', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Very much improved', 'measurements': [{'value': '24', 'groupId': 'OG000'}]}, {'title': 'Much improved', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': 'Improved', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'No change', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': 'At Month 9', 'description': 'Aesthetic improvement was assessed by comparing a photograph taken before the first treatment at the baseline visit to current visit. On a 7-graded GAIS from "very much worse" to "very much improved" as follows; very much improved, much improved, improved, no change, worse, much worse and very much worse. Responder was defined as a participant with a rating of at least improved as assessed by the treating investigator (assessed as very much improved, much improved or improved) compared to pre-treatment. Number of aesthetic improved thighs of responders based on treating investigator assessment using GAIS at Month 9 were reported.', 'unitOfMeasure': 'Thighs', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Thighs', 'denomUnitsSelected': 'Thighs', 'populationDescription': 'Full Analysis Set (FAS) Included all participants who were injected in both thighs.'}, {'type': 'SECONDARY', 'title': 'Number of Aesthetic Improved Thighs of Responders According to Global Aesthetic Improvement Scale (GAIS) as Assessed Live by Treating Investigator at Month 1, 2, 6 and 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}, {'units': 'Thighs', 'counts': [{'value': '58', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Group (Sculptra)', 'description': 'Participants with intent to undergo treatment to improve appearance of cellulite were enrolled and treated with Sculptra in three sessions spaced one month (+2 weeks) apart. Participants were treated at baseline, Month 1 and Month 2.'}], 'classes': [{'title': 'Month 1, Left thigh', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}, {'units': 'Thighs', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Very much improved', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Much improved', 'measurements': [{'value': '8', 'groupId': 'OG000'}]}, {'title': 'Improved', 'measurements': [{'value': '16', 'groupId': 'OG000'}]}, {'title': 'No change', 'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Month 1, Right thigh', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}, {'units': 'Thighs', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Very much improved', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Much improved', 'measurements': [{'value': '6', 'groupId': 'OG000'}]}, {'title': 'Improved', 'measurements': [{'value': '17', 'groupId': 'OG000'}]}, {'title': 'No change', 'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Month 2, Left thigh', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}, {'units': 'Thighs', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Very much improved', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'Much improved', 'measurements': [{'value': '8', 'groupId': 'OG000'}]}, {'title': 'Improved', 'measurements': [{'value': '19', 'groupId': 'OG000'}]}, {'title': 'No change', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Month 2, Right thigh', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}, {'units': 'Thighs', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Very much improved', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'Much improved', 'measurements': [{'value': '8', 'groupId': 'OG000'}]}, {'title': 'Improved', 'measurements': [{'value': '19', 'groupId': 'OG000'}]}, {'title': 'No change', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Month 6, Left thigh', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}, {'units': 'Thighs', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Very much improved', 'measurements': [{'value': '16', 'groupId': 'OG000'}]}, {'title': 'Much improved', 'measurements': [{'value': '7', 'groupId': 'OG000'}]}, {'title': 'Improved', 'measurements': [{'value': '6', 'groupId': 'OG000'}]}, {'title': 'No change', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Month 6, Right thigh', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}, {'units': 'Thighs', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Very much improved', 'measurements': [{'value': '16', 'groupId': 'OG000'}]}, {'title': 'Much improved', 'measurements': [{'value': '6', 'groupId': 'OG000'}]}, {'title': 'Improved', 'measurements': [{'value': '7', 'groupId': 'OG000'}]}, {'title': 'No change', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Month 12, Left thigh', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}, {'units': 'Thighs', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Very much improved', 'measurements': [{'value': '18', 'groupId': 'OG000'}]}, {'title': 'Much improved', 'measurements': [{'value': '10', 'groupId': 'OG000'}]}, {'title': 'Improved', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'No change', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Month 12, Right thigh', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}, {'units': 'Thighs', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Very much improved', 'measurements': [{'value': '19', 'groupId': 'OG000'}]}, {'title': 'Much improved', 'measurements': [{'value': '8', 'groupId': 'OG000'}]}, {'title': 'Improved', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'No change', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': 'At month 1, 2, 6 and 12', 'description': 'Aesthetic improvement was assessed by comparing a photograph taken before the first treatment at the baseline visit to a photograph from the current visit. on a 7-graded GAIS from "very much worse" to "very much improved" as follows; very much improved, much improved, improved, no change, worse, much worse and very much worse. Responder was defined as a participant with a rating of at least improved as assessed by the treating investigator (assessed as very much improved, much improved or improved) compared to pre-treatment. Number of aesthetic improved thighs of responders based on treating investigator assessment using GAIS at Month 1,2,6 and 12 were reported.', 'unitOfMeasure': 'Thighs', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Thighs', 'denomUnitsSelected': 'Thighs', 'populationDescription': 'Full Analysis Set (FAS) Included all participants who were injected in both thighs.'}, {'type': 'SECONDARY', 'title': 'Number of Aesthetic Improved Thighs of Responders According to Global Aesthetic Improvement Scale (GAIS) as Assessed by Participant Photography at Month 1, 2, 6, 9 and 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}, {'units': 'Thighs', 'counts': [{'value': '58', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Group (Sculptra)', 'description': 'Participants with intent to undergo treatment to improve appearance of cellulite were enrolled and treated with Sculptra in three sessions spaced one month (+2 weeks) apart. Participants were treated at baseline, Month 1 and Month 2.'}], 'classes': [{'title': 'Month 1, Left thigh', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}, {'units': 'Thighs', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Very much improved', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'Much improved', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': 'Improved', 'measurements': [{'value': '19', 'groupId': 'OG000'}]}, {'title': 'No change', 'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Month 1, Right thigh', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}, {'units': 'Thighs', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Very much improved', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'Much improved', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'Improved', 'measurements': [{'value': '20', 'groupId': 'OG000'}]}, {'title': 'No change', 'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Month 2, Left thigh', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}, {'units': 'Thighs', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Very much improved', 'measurements': [{'value': '5', 'groupId': 'OG000'}]}, {'title': 'Much improved', 'measurements': [{'value': '8', 'groupId': 'OG000'}]}, {'title': 'Improved', 'measurements': [{'value': '14', 'groupId': 'OG000'}]}, {'title': 'No change', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Month 2, Right thigh', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}, {'units': 'Thighs', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Very much improved', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}, {'title': 'Much improved', 'measurements': [{'value': '9', 'groupId': 'OG000'}]}, {'title': 'Improved', 'measurements': [{'value': '14', 'groupId': 'OG000'}]}, {'title': 'No change', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Month 6, Left thigh', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}]}, {'units': 'Thighs', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Very much improved', 'measurements': [{'value': '6', 'groupId': 'OG000'}]}, {'title': 'Much improved', 'measurements': [{'value': '9', 'groupId': 'OG000'}]}, {'title': 'Improved', 'measurements': [{'value': '11', 'groupId': 'OG000'}]}, {'title': 'No change', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Month 6, Right thigh', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}]}, {'units': 'Thighs', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Very much improved', 'measurements': [{'value': '6', 'groupId': 'OG000'}]}, {'title': 'Much improved', 'measurements': [{'value': '8', 'groupId': 'OG000'}]}, {'title': 'Improved', 'measurements': [{'value': '13', 'groupId': 'OG000'}]}, {'title': 'No change', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Month 9, Left thigh', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}, {'units': 'Thighs', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Very much improved', 'measurements': [{'value': '11', 'groupId': 'OG000'}]}, {'title': 'Much improved', 'measurements': [{'value': '5', 'groupId': 'OG000'}]}, {'title': 'Improved', 'measurements': [{'value': '11', 'groupId': 'OG000'}]}, {'title': 'No change', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Month 9, Right thigh', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}, {'units': 'Thighs', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Very much improved', 'measurements': [{'value': '11', 'groupId': 'OG000'}]}, {'title': 'Much improved', 'measurements': [{'value': '5', 'groupId': 'OG000'}]}, {'title': 'Improved', 'measurements': [{'value': '12', 'groupId': 'OG000'}]}, {'title': 'No change', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Month 12, Left thigh', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}, {'units': 'Thighs', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Very much improved', 'measurements': [{'value': '12', 'groupId': 'OG000'}]}, {'title': 'Much improved', 'measurements': [{'value': '5', 'groupId': 'OG000'}]}, {'title': 'Improved', 'measurements': [{'value': '10', 'groupId': 'OG000'}]}, {'title': 'No change', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Month 12, Right thigh', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}, {'units': 'Thighs', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Very much improved', 'measurements': [{'value': '11', 'groupId': 'OG000'}]}, {'title': 'Much improved', 'measurements': [{'value': '6', 'groupId': 'OG000'}]}, {'title': 'Improved', 'measurements': [{'value': '10', 'groupId': 'OG000'}]}, {'title': 'No change', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': 'At Months 1, 2, 6, 9 and 12', 'description': 'Aesthetic improvement was assessed by comparing a photograph taken before the first treatment at the baseline visit to a photograph from the current visit. on a 7-graded GAIS from "very much worse" to "very much improved" as follows; very much improved, much improved, improved, no change, worse, much worse and very much worse. Responder was defined as a participant with a rating of at least improved as assessed by themselves (assessed as very much improved, much improved or improved) compared to pre-treatment. Number of aesthetic improved thighs of responders based on participant photography assessment using GAIS at Month 1,2,6 and 12 were reported.', 'unitOfMeasure': 'Thighs', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Thighs', 'denomUnitsSelected': 'Thighs', 'populationDescription': 'Full Analysis Set (FAS) Included all participants who were injected in both thighs. Here, "Number analyzed" signifies those units (thighs) which were evaluable at the specified timeframe.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Treatment Group (Sculptra)', 'description': 'Participants with intent to undergo treatment to improve appearance of cellulite were enrolled and treated with Sculptra in three sessions spaced one month (+2 weeks) apart. Participants were treated at baseline, Month 1 and Month 2.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '29'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '29'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'This study was conducted at Canada from 19 November 2021 to 27 February 2023.', 'preAssignmentDetails': 'A total of 29 participants were enrolled in the study. All enrolled participants were treated and completed the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Treatment Group (Sculptra)', 'description': 'Participants with intent to undergo treatment to improve appearance of cellulite were enrolled and treated with Sculptra in three sessions spaced one month (+2 weeks) apart. Participants were treated at baseline, Month 1 and Month 2.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '41.2', 'spread': '9.01', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '29', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '27', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', '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': '5', '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': '23', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-06-21', 'size': 2372895, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-06-10T05:29', 'hasProtocol': True}, {'date': '2022-11-29', 'size': 760137, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-06-14T03:30', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 29}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-11-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2023-02-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-14', 'studyFirstSubmitDate': '2021-09-22', 'resultsFirstSubmitDate': '2024-06-14', 'studyFirstSubmitQcDate': '2021-09-30', 'lastUpdatePostDateStruct': {'date': '2024-09-26', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-06-14', 'studyFirstPostDateStruct': {'date': '2021-10-01', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-09-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Aesthetic Improved Thighs of Responders According to Global Aesthetic Improvement Scale (GAIS) as Assessed Live by Treating Investigator at Month 9', 'timeFrame': 'At Month 9', 'description': 'Aesthetic improvement was assessed by comparing a photograph taken before the first treatment at the baseline visit to current visit. On a 7-graded GAIS from "very much worse" to "very much improved" as follows; very much improved, much improved, improved, no change, worse, much worse and very much worse. Responder was defined as a participant with a rating of at least improved as assessed by the treating investigator (assessed as very much improved, much improved or improved) compared to pre-treatment. Number of aesthetic improved thighs of responders based on treating investigator assessment using GAIS at Month 9 were reported.'}], 'secondaryOutcomes': [{'measure': 'Number of Aesthetic Improved Thighs of Responders According to Global Aesthetic Improvement Scale (GAIS) as Assessed Live by Treating Investigator at Month 1, 2, 6 and 12', 'timeFrame': 'At month 1, 2, 6 and 12', 'description': 'Aesthetic improvement was assessed by comparing a photograph taken before the first treatment at the baseline visit to a photograph from the current visit. on a 7-graded GAIS from "very much worse" to "very much improved" as follows; very much improved, much improved, improved, no change, worse, much worse and very much worse. Responder was defined as a participant with a rating of at least improved as assessed by the treating investigator (assessed as very much improved, much improved or improved) compared to pre-treatment. Number of aesthetic improved thighs of responders based on treating investigator assessment using GAIS at Month 1,2,6 and 12 were reported.'}, {'measure': 'Number of Aesthetic Improved Thighs of Responders According to Global Aesthetic Improvement Scale (GAIS) as Assessed by Participant Photography at Month 1, 2, 6, 9 and 12', 'timeFrame': 'At Months 1, 2, 6, 9 and 12', 'description': 'Aesthetic improvement was assessed by comparing a photograph taken before the first treatment at the baseline visit to a photograph from the current visit. on a 7-graded GAIS from "very much worse" to "very much improved" as follows; very much improved, much improved, improved, no change, worse, much worse and very much worse. Responder was defined as a participant with a rating of at least improved as assessed by themselves (assessed as very much improved, much improved or improved) compared to pre-treatment. Number of aesthetic improved thighs of responders based on participant photography assessment using GAIS at Month 1,2,6 and 12 were reported.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cellulite']}, 'descriptionModule': {'briefSummary': 'This pilot study has been designed to evaluate the safety and effectiveness of PLLA as a single regimen for the improvement in appearance of cellulite after changes in reconstitution procedure.', 'detailedDescription': "Cellulite is a topographic and localized skin condition that is commonly found on the posterolateral thighs, buttocks, and abdomen. It is often identified by a dimpled or orange-peel appearance of the skin's surface. The presence of visible cellulite is associated with histologic changes in the dermis, adipose tissue, and septae.\n\nBased on the theory that a stronger skin structure, with a decrease in skin laxity and increase in dermal thickness, could reduce the appearance of cellulite, the Sponsor intends to investigate the safety and effectiveness of PLLA for the improvement in appearance of cellulite in the posterior thighs."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects with intent to undergo treatment to improve appearance of cellulite in the posterior thighs.\n\nExclusion Criteria:\n\n* Known/previous allergy or hypersensitivity to any of the Sculptra constituents.\n* Known/previous allergy or hypersensitivity to lidocaine and other local anesthetics, e.g. amide-type anesthetics, or topical anesthetics or nerve blocking agents.\n* Previous or present multiple allergies or severe allergies, such as manifested by anaphylaxis or angioedema, or family history of these conditions.\n* Previous treatment/procedure in or near the treatment area:\n\n 1. Previous permanent implant, filler, lifting threads, or autologous fat in the treatment area, regardless of time.\n 2. Previous semi-permanent implants exemplified by Calcium Hydroxylapatite (CaHA), poly l-lactic acid (PLLA) in treatment area, regardless of time.\n 3. Previous Hyaluronic acid (HA) filler or collagen filler in the treatment area within 12 months.\n 4. Previous energy based aesthetic procedures (e.g. laser, intense pulsed light, radiofrequency and endermology) in the treatment area within 6 months.\n 5. Previous mechanical (e.g. dermabrasion, needling) or chemical aesthetic procedures (e.g. chemical peel) in the treatment area within 6 months.\n 6. Previous treatment with cryotherapy, lipolytic treatments or liporeduction massage in the treatment area within 6 months.'}, 'identificationModule': {'nctId': 'NCT05064761', 'briefTitle': 'Safety and Effectiveness of Poly-l-lactic Acid (PLLA) for the Improvement in Appearance of Cellulite', 'organization': {'class': 'INDUSTRY', 'fullName': 'Galderma R&D'}, 'officialTitle': 'A Pilot Study to Evaluate Safety and Effectiveness of Poly-l-lactic Acid (PLLA) for the Improvement in Appearance of Cellulite', 'orgStudyIdInfo': {'id': '43CASA2006'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment group', 'description': 'PLLA new dilution for treatment to improve appearance of cellulite.', 'interventionNames': ['Device: Sculptra new dilution']}], 'interventions': [{'name': 'Sculptra new dilution', 'type': 'DEVICE', 'description': 'Treatment to improve appearance of cellulite.', 'armGroupLabels': ['Treatment group']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'V5Z4E1', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Galderma Research Site', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}], 'overallOfficials': [{'name': 'Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Galderma R&D'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Galderma R&D', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}