Ignite Creation Date:
2025-12-25 @ 2:24 AM
Ignite Modification Date:
2026-03-05 @ 9:51 AM
Study NCT ID:
NCT01519934
Status:
COMPLETED
Last Update Posted:
2017-12-18
First Post:
2011-11-07
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Retrospective Study to Evaluate the Effectiveness of the Ulthera System
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003483', 'term': 'Cutis Laxa'}], 'ancestors': [{'id': 'D012873', 'term': 'Skin Diseases, Genetic'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@merz.com', 'title': 'Public Disclosure Manager', 'organization': 'Merz Pharmaceuticals'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected from enrollment to 6 months post-treatment.', 'eventGroups': [{'id': 'EG000', 'title': 'Ulthera-treated Subjects', 'description': 'All enrolled subjects will have received an Ulthera treatment prior to enrollment.', 'otherNumAtRisk': 48, 'otherNumAffected': 0, 'seriousNumAtRisk': 48, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Improvement in Overall Lifting and Tightening of the Skin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ulthera-treated Subjects', 'description': 'All enrolled subjects will have received an Ulthera treatment prior to enrollment.'}], 'classes': [{'categories': [{'measurements': [{'value': '67', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to 180 days post-treatment', 'description': 'Determined by a masked, qualitative assessment of photographs at 180 days post treatment compared to pre-treatment baseline photographs. A panel of three blinded assessors reviewed pre-treatment and post-treatment photos. Each blinded assessor was provided an identical set of pre-treatment and Day 180 post-treatment photos to assess. The pre/post treatment photos were consistent in lighting, subject positioning and focus. The visit interval of each photo, i.e. pre and post treatment, was NOT marked. Each blinded assessor conducted their assessment independently with no input from another blinded assessor, comparing each set of photos. Each assessor indicated those subjects assessed as improved.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Overall Aesthetic Improvement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ulthera-treated Subjects', 'description': 'All enrolled subjects will have received an Ulthera treatment prior to enrollment.'}], 'classes': [{'title': 'Investigator GAIS', 'categories': [{'measurements': [{'value': '78', 'groupId': 'OG000'}]}]}, {'title': 'Subject GAIS', 'categories': [{'measurements': [{'value': '78', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to 180 days post-treatment', 'description': 'Overall aesthetic improvement was assessed based on a Global Aesthetic Improvement Scale (GAIS) scores; PGAIS completed by a clinician assessor, SGAIS completed by the study subject. The GAIS is 5-point scale (1-5) describing an overall assessment as follows:\n\n1. = Very Much Improved\n2. = Much Improved\n3. = Improved\n4. = No Change\n5. = Worse', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Subject Perception of Age', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ulthera-treated Subjects', 'description': 'All enrolled subjects will have received an Ulthera treatment prior to enrollment.'}], 'classes': [{'categories': [{'measurements': [{'value': '60', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to 180 days post-treatment', 'description': 'Percentage of subjects rated as "looking younger" as measured using a Subject Perception of Age questionnaire.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Patient Satisfaction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ulthera-treated Subjects', 'description': 'All enrolled subjects will have received an Ulthera treatment prior to enrollment.'}], 'classes': [{'categories': [{'measurements': [{'value': '60', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '180 days post-treatment', 'description': 'Percentage of subjects reporting satisfaction as measured using a Patient Satisfaction Questionnaire.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Ulthera-treated Subjects', 'description': 'All enrolled subjects had received one Ulthera treatment on the face and neck at two treatment depths, 4.5mm and 3.0mm depths, prior to enrollment.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '48'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '45'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}]}], 'recruitmentDetails': 'Subjects who had received an Ulthera treatment to the face and upper neck at two treatment depths at one study site were recruited for study participation.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Ulthera-treated Subjects', 'description': 'All enrolled subjects will have received an Ulthera treatment prior to enrollment.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '58', 'groupId': 'BG000', 'lowerLimit': '39', 'upperLimit': '85'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '48', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Asian', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}, {'title': 'Caucasian', 'categories': [{'measurements': [{'value': '42', 'groupId': 'BG000'}]}]}, {'title': 'Hispanic/Latino', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}, {'title': 'More than one race', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '48', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Subjects who had received a dual depth Ulthera treatment to the face and upper neck prior to enrollment and met all entrance criteria.'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-11', 'completionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-11-10', 'studyFirstSubmitDate': '2011-11-07', 'resultsFirstSubmitDate': '2013-12-30', 'studyFirstSubmitQcDate': '2012-01-26', 'lastUpdatePostDateStruct': {'date': '2017-12-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2014-03-19', 'studyFirstPostDateStruct': {'date': '2012-01-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-04-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Improvement in Overall Lifting and Tightening of the Skin', 'timeFrame': 'Baseline to 180 days post-treatment', 'description': 'Determined by a masked, qualitative assessment of photographs at 180 days post treatment compared to pre-treatment baseline photographs. A panel of three blinded assessors reviewed pre-treatment and post-treatment photos. Each blinded assessor was provided an identical set of pre-treatment and Day 180 post-treatment photos to assess. The pre/post treatment photos were consistent in lighting, subject positioning and focus. The visit interval of each photo, i.e. pre and post treatment, was NOT marked. Each blinded assessor conducted their assessment independently with no input from another blinded assessor, comparing each set of photos. Each assessor indicated those subjects assessed as improved.'}], 'secondaryOutcomes': [{'measure': 'Overall Aesthetic Improvement', 'timeFrame': 'Baseline to 180 days post-treatment', 'description': 'Overall aesthetic improvement was assessed based on a Global Aesthetic Improvement Scale (GAIS) scores; PGAIS completed by a clinician assessor, SGAIS completed by the study subject. The GAIS is 5-point scale (1-5) describing an overall assessment as follows:\n\n1. = Very Much Improved\n2. = Much Improved\n3. = Improved\n4. = No Change\n5. = Worse'}, {'measure': 'Subject Perception of Age', 'timeFrame': 'Baseline to 180 days post-treatment', 'description': 'Percentage of subjects rated as "looking younger" as measured using a Subject Perception of Age questionnaire.'}, {'measure': 'Patient Satisfaction', 'timeFrame': '180 days post-treatment', 'description': 'Percentage of subjects reporting satisfaction as measured using a Patient Satisfaction Questionnaire.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Ulthera® System', 'Ultherapy™ Treatment', 'Ulthera, Inc.', 'Ultrasound treatment for skin tightening'], 'conditions': ['Skin Laxity', 'Wrinkles']}, 'descriptionModule': {'briefSummary': "Up to 120 subjects within the study site's practice who have already had an Ultherapy™ treatment to the face and neck will be enrolled to monitor treatment effectiveness. Follow-up visits will occur at 90 and 180 days post-treatment. Study images will be obtained at each follow-up visit.", 'detailedDescription': 'This is a retrospective, single-center clinical trial to evaluate the efficacy of the Ulthera System for non-invasive treatment of skin texture and laxity six months after treatment. Global Aesthetic Improvement Scale scores, patient satisfaction questionnaires, and quality of life questionnaires will be obtained.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '25 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "The study population will consist of males and females from the investigator's practice between 25 and 85 years of age, who have received an Ultherapy™ treatment on or prior to October 1, 2011, who had pre-treatment baseline photographs taken, and who have chosen to participate in this clinical trial.", 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female, age 25-85 years.\n* Subject in good health.\n* Received Ultherapy™ treatment prior to or on October 1, 2011, and must have had pre-treatment baseline photographs taken.\n* Willingness and ability to comply with protocol requirements, including returning for follow-up visits.\n* Absence of physical or psychological conditions unacceptable to the investigator.\n\nExclusion Criteria:\n\n* Presence of an active systemic or local skin disease that may affect wound healing.\n* Significant scarring in areas treated.\n* Open wounds or lesions in the areas treated.\n* Severe or cystic acne on the areas treated.\n* Inability to understand the protocol or to give informed consent.'}, 'identificationModule': {'nctId': 'NCT01519934', 'briefTitle': 'A Retrospective Study to Evaluate the Effectiveness of the Ulthera System', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merz North America, Inc.'}, 'officialTitle': 'Retrospective Evaluation of the Ulthera System for Lifting and Tightening of the Face and Neck', 'orgStudyIdInfo': {'id': 'ULT-120'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Ulthera-treated subjects', 'description': 'All enrolled subjects will have received an Ulthera treatment prior to enrollment.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '92121', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Dermatology Cosmetic Laser Associates', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}], 'overallOfficials': [{'name': 'Mitchel Goldman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dermatology Cosmetic Laser Associates'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ulthera, Inc', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}