Ignite Creation Date:
2025-12-26 @ 11:14 AM
Ignite Modification Date:
2025-12-29 @ 6:01 PM
Study NCT ID:
NCT05538728
Status:
COMPLETED
Last Update Posted:
2024-08-20
First Post:
2022-09-08
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
An Open-label Study of Poly-l-lactic Acid for Correction of Wrinkles in the décolletage Area
Sponsor:
Organization:
Raw JSON
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After first treatment, if needed, an additional 3 treatment sessions were performed at 1 month (+ 2 weeks) interval. Treatment was continued till optimal correction, which was defined as at least one grade improvement on Galderma Decolletage Scale (GDS) and best correction that achieved as agreed upon by the Treating Investigator and the participant.'}, {'id': 'OG001', 'title': 'Sculptra 17ml', 'description': 'Participants received first treatment injection sub-dermally with Sculptra 17ml (reconstituted with 17 mL SWFI + 1 mL lidocaine hydrochloride 2%) at Day 1. After first treatment, if needed, an additional 3 treatment sessions were performed at 1 month (+ 2 weeks) interval. 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Treatment was continued till optimal correction, which was defined as at least one grade improvement on GDS and best correction that achieved as agreed upon by the Treating Investigator and the participant.'}], 'classes': [{'categories': [{'measurements': [{'value': '93.3', 'groupId': 'OG000', 'lowerLimit': '68.1', 'upperLimit': '99.8'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '73.5', 'upperLimit': '100.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Month 6', 'description': 'Responder was defined as participants having at least one grade improvement from baseline. GDS was a validated 5-point scale used to assess the severity of lines and wrinkles in the décolletage area: Grade 0 (none to minimal), Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), Grade 4 (very severe). 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Here, 'number analyzed, n' signifies participants evaluable for specified time points."}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Sculptra 8ml', 'description': 'Participants received first treatment injection sub-dermally with Sculptra 8 milliliters (ml; current labeled total volume: reconstituted with 8 mL sterile water for injection \\[SWFI\\] + 1 mL lidocaine hydrochloride 2 percent \\[%\\]) at Day 1. After first treatment, if needed, an additional 3 treatment sessions were performed at 1 month (+ 2 weeks) interval. Treatment was continued till optimal correction, which was defined as at least one grade improvement on Galderma Decolletage Scale (GDS) and best correction that achieved as agreed upon by the Treating Investigator and the participant.'}, {'id': 'FG001', 'title': 'Sculptra 17ml', 'description': 'Participants received first treatment injection sub-dermally with Sculptra 17ml (reconstituted with 17 mL SWFI + 1 mL lidocaine hydrochloride 2%) at Day 1. After first treatment, if needed, an additional 3 treatment sessions were performed at 1 month (+ 2 weeks) interval. Treatment was continued till optimal correction, which was defined as at least one grade improvement on GDS and best correction that achieved as agreed upon by the Treating Investigator and the participant.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '14'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'This study was conducted at the United States from 31 August 2022 to 08 August 2023.', 'preAssignmentDetails': 'A total of 30 participants were enrolled and treated in this study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Sculptra 8ml', 'description': 'Participants received first treatment injection sub-dermally with Sculptra 8 milliliters (ml; current labeled total volume: reconstituted with 8 mL sterile water for injection \\[SWFI\\] + 1 mL lidocaine hydrochloride 2 percent \\[%\\]) at Day 1. After first treatment, if needed, an additional 3 treatment sessions were performed at 1 month (+ 2 weeks) interval. Treatment was continued till optimal correction, which was defined as at least one grade improvement on Galderma Decolletage Scale (GDS) and best correction that achieved as agreed upon by the Treating Investigator and the participant.'}, {'id': 'BG001', 'title': 'Sculptra 17ml', 'description': 'Participants received first treatment injection sub-dermally with Sculptra 17ml (reconstituted with 17 mL SWFI + 1 mL lidocaine hydrochloride 2%) at Day 1. After first treatment, if needed, an additional 3 treatment sessions were performed at 1 month (+ 2 weeks) interval. Treatment was continued till optimal correction, which was defined as at least one grade improvement on GDS and best correction that achieved as agreed upon by the Treating Investigator and the participant.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '53.2', 'spread': '9.77', 'groupId': 'BG000'}, {'value': '55.0', 'spread': '8.88', 'groupId': 'BG001'}, {'value': '54.0', 'spread': '9.25', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '25', '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': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', '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': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Intent to treat (ITT) population Included all participants who were randomized and analyzed according to the treatment they were randomized based on the randomization scheme.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-05-31', 'size': 5126993, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-07-25T02:07', 'hasProtocol': True}, {'date': '2023-03-06', 'size': 1724563, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-07-25T02:09', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-08-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2023-08-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-30', 'studyFirstSubmitDate': '2022-09-08', 'resultsFirstSubmitDate': '2024-07-30', 'studyFirstSubmitQcDate': '2022-09-13', 'lastUpdatePostDateStruct': {'date': '2024-08-20', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-07-30', 'studyFirstPostDateStruct': {'date': '2022-09-14', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-08-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Responders on the Galderma Décolletage Scale (GDS), as Assessed Live by the Treating Investigator, at Month 9', 'timeFrame': 'At Month 9', 'description': 'Responder was defined as participants having at least one grade improvement from baseline. GDS was a validated 5-point scale used to assess the severity of lines and wrinkles in the décolletage area: Grade 0 (none to minimal), Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), Grade 4 (very severe). Higher score meant very severe lines and wrinkles in the décolletage area.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Responders on the Galderma Décolletage Scale, as Assessed Live by the Treating Investigator, at Month 6', 'timeFrame': 'At Month 6', 'description': 'Responder was defined as participants having at least one grade improvement from baseline. GDS was a validated 5-point scale used to assess the severity of lines and wrinkles in the décolletage area: Grade 0 (none to minimal), Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), Grade 4 (very severe). Higher score meant very severe lines and wrinkles in the décolletage area.'}, {'measure': 'Percentage of Responders Who Achieved At Least "Improved" on the Global Aesthetic Improvement Scale (GAIS) as Assessed by Participant at Months 6 and 9', 'timeFrame': 'At Month 6 and 9', 'description': 'Responder was defined as participants achieving \'very much improved\', \'much improved\' or "Improved" on GAIS compared to baseline. The 7-graded GAIS was used by the participant to live assess the severity of lines and wrinkles by responding to the question: "Please choose the response below that best describes the overall change in the appearance of your upper chest area since you received the study treatment " by using the respective categorical scale as follows: Very Much Improved, Much Improved, Improved, No Change, Worse, Much Worse, Very Much Worse. In this outcome measure, percentage of participants who achieved at least \'Improved\' on the GAIS assessed by participant at Months 6 and 9 were reported.'}, {'measure': 'Percentage of Responders With At Least "Improved" on the Global Aesthetic Improvement Scale (GAIS) as Assessed by Treating Investigator at Months 6 and 9', 'timeFrame': 'At Months 6 and 9', 'description': 'Responder was defined as participants achieving \'very much improved\', \'much improved\' or "Improved" on GAIS compared to baseline. The 7-graded GAIS was used by the Treating Investigator to live assess the severity of lines and wrinkles by responding to the question: "Please choose the response below that best describes the overall change in the appearance of your upper chest area since you received the study treatment " by using the respective categorical scale as follows; Very Much Improved, Much Improved, Improved, No Change, Worse, Much Worse, Very Much Worse. In this outcome measure, percentage of participants who achieved at least \'Improved\' on the GAIS assessed by treating investigator at Months 6 and 9 were reported.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Wrinkles in Decolletage']}, 'descriptionModule': {'briefSummary': 'This is a prospective open-label study to evaluate safety and effectiveness of two different reconstitution volumes of poly-l-lactic acid (PLLA) for correction of wrinkles in the décolletage area.', 'detailedDescription': 'A challenge for wrinkle correction of the decolletage/chest and other non-facial areas is that larger surface areas typically need to be treated than for facial indications, for which reason the Sponsor is investigating a larger reconstitution volume compared to the approved label. In this study, the total volume of 18mL, including 1mL of 2% lidocaine, is being explored and compared with results from the current labeled volume of 9mL, including lidocaine, to assess if the larger volume is well-tolerated for treatment for wrinkles in the decolletage area.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '22 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Non-pregnant, non-breastfeeding females over the age of 22\n* subjects seeking treatment for the décolletage\n* subjects with moderate (Grade 2) or severe (Grade 3) on the Galderma Décolletage Scale\n* subjects willing to abstain from any other surgical or cosmetic procedures in the décolletage area for the duration of the study.\n\nExclusion Criteria:\n\n* Known/previous allergy or hypersensitivity to Sculptra\n* Previous tissue augmenting therapy, contouring or revitalization treatment in the décolletage prior to baseline\n* Any plastic surgery or permanent surgical implant in the treatment area\n* Previous treatment/procedure in the treatment area in the previous 6 months that would interfere with study injections or study assessments'}, 'identificationModule': {'nctId': 'NCT05538728', 'briefTitle': 'An Open-label Study of Poly-l-lactic Acid for Correction of Wrinkles in the décolletage Area', 'organization': {'class': 'INDUSTRY', 'fullName': 'Galderma R&D'}, 'officialTitle': 'A Prospective Open-label Study to Evaluate Safety and Effectiveness of Two Different Reconstitution Volumes of Poly-l-lactic Acid (PLLA) for Correction of Wrinkles in the décolletage Area', 'orgStudyIdInfo': {'id': '43USSA2112'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '8ml', 'description': 'Device: Sculptra current label dilution for treatment of wrinkles in the decolletage area', 'interventionNames': ['Device: poly-l-lactic acid (Sculptra)']}, {'type': 'ACTIVE_COMPARATOR', 'label': '17ml', 'description': 'Experimental: PLLA new dilution volume for treatment of wrinkles in the decolletage area', 'interventionNames': ['Device: poly-l-lactic acid (Sculptra)']}], 'interventions': [{'name': 'poly-l-lactic acid (Sculptra)', 'type': 'DEVICE', 'description': 'Sculptra', 'armGroupLabels': ['17ml', '8ml']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91436', 'city': 'Encino', 'state': 'California', 'country': 'United States', 'facility': 'Galderma Study Site', 'geoPoint': {'lat': 34.15917, 'lon': -118.50119}}, {'zip': '92075', 'city': 'Solana Beach', 'state': 'California', 'country': 'United States', 'facility': 'Galderma Study Site', 'geoPoint': {'lat': 32.99115, 'lon': -117.27115}}], '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'}}}}