Ignite Creation Date:
2025-12-24 @ 10:30 PM
Ignite Modification Date:
2026-02-20 @ 6:52 PM
Study NCT ID:
NCT01368835
Status:
COMPLETED
Last Update Posted:
2017-12-13
First Post:
2011-06-06
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluation of the Ulthera™ System for Obtaining Lift and Tightening of the Cheek Tissue
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@merz.com', 'title': 'Public Disclosure Manager', 'organization': 'Merz Pharmaceuticals'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Baseline, Treatment, D90, D180', 'description': 'Device and/or procedure related adverse events', 'eventGroups': [{'id': 'EG000', 'title': 'Ulthera Treatment', 'description': 'Treatment to the lower face and submental region.', 'otherNumAtRisk': 103, 'otherNumAffected': 0, 'seriousNumAtRisk': 103, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Overall Lifting and Tightening of Treated Tissue on the Lower Face and Submental Regions.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ulthera Treatment', 'description': 'Subjects who received one focused ultrasound treatment to the lower face and submental regions using the Ultera System.'}], 'classes': [{'categories': [{'measurements': [{'value': '68.60', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '90D', 'description': 'The percentage of participants assessed to have improvement in skin laxity, i.e., lifted and tightened skin in the areas treated with the Ulthera System, as determined by three masked assessors comparing pre-treatment and 90-days post-treatment photos from 70 subjects who returned for their 90-day follow-up visit.', 'unitOfMeasure': 'percentage of participants improved', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants who received an Ulthera treatment and for whom pre-treatment and 90-day post-treatment photos were available, i.e., evaluable participants, for a masked assessment.'}, {'type': 'SECONDARY', 'title': 'Change in Submental and Neck Skin Laxity by Quantitative Analysis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ulthera Treatment', 'description': 'Treatment to the lower face and submental region.'}], 'classes': [{'categories': [{'measurements': [{'value': '72.9', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '90D', 'description': 'The percentage of participants assessed as having an improvement in tissue lift, i.e., \\>20mm2 in submental and neck skin laxity, at 90 Days post-treatment compared to baseline based on quantitative analysis.', 'unitOfMeasure': 'percentage of participants improved', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants who received an Ulthera treatment and for whom pre-treatment and 90-day post-treatment photos were available, i.e., evaluable participants.'}, {'type': 'SECONDARY', 'title': 'Patient Satisfaction Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ulthera Treatment', 'description': 'Treatment to the lower face and submental region.'}], 'classes': [{'categories': [{'measurements': [{'value': '67', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '90D', 'description': "Subjects indicated whether they saw improvement, i.e., providing a Yes/No response, in face and neck characteristics at three months (D90) post Ulthera treatment. Pre-treatment and Day 90 post-treatment photographs were available for viewing during the assessment. Subjects also had a mirror in hand for real time assessment. Subjects' Yes/No responses were tabulated.", 'unitOfMeasure': 'percentage of participants improved', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants who received an Ulthera treatment and for whom pre-treatment and 90-day post-treatment photos were available.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Subject Assessment of Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ulthera Treatment', 'description': 'Treatment to the lower face and submental region.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.13', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '10'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'During Ulthera study treatment', 'description': "Subject assessment of pain using a validated Numeric Rating Scale (NRS), 0-10, where 0 = no pain and 10=worse pain possible. Subjects' sensory responses to the treatment exposures were recorded using the NRS for each anatomical region.", 'unitOfMeasure': 'Average NRS score', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable subjects, i.e., n=70, who received an Ulthera treatment and for whom an NRS was completed.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Ulthera Treatment', 'description': 'Subjects will receive one dual-depth focused ultrasound treatment to their lower face and submental regions.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': '103 Subjects Enrolled', 'groupId': 'FG000', 'numSubjects': '103'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '70'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '33'}]}], 'dropWithdraws': [{'type': 'Inclusion criteria/photography quality', 'reasons': [{'groupId': 'FG000', 'numSubjects': '22'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}]}]}], 'recruitmentDetails': 'Recruitment from June 30, 2010 to August 31, 2010.', 'preAssignmentDetails': 'Male or Female, aged 30 to 60 years. Desire to lift and tighten cheek tissue, improve jawline definition and/or submental skin laxity.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Ulthera Treatment', 'description': 'Treatment to the lower face and submental region.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '49.5', 'groupId': 'BG000', 'lowerLimit': '35', 'upperLimit': '58'}]}]}], 'paramType': 'MEAN', 'description': 'Average patient age', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '57', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '13', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '70', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Fitzpatrick Skin Type', 'classes': [{'title': 'Skin Type I', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}]}]}, {'title': 'Skin Type II', 'categories': [{'measurements': [{'value': '46', 'groupId': 'BG000'}]}]}, {'title': 'Skin Type III', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}]}]}, {'title': 'Skin Type IV', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}, {'title': 'Skin Type V', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': 'Skin Type I = White; very fair, red or blonde hair blue eyes; freckles; Always burns, never tans\n\nSkin Type II = White, fair, red or blond hair; blue, hazel or green eyes; Usually burns, tans with difficulty\n\nSkin Type III = Cream white; fair with any eye or hair color (common); Sometimes mild burn, gradually tans\n\nSkin Type IV = Brown; typical Mediterranean Caucasian skin; Rarely burns, tans with ease\n\nSkin Type V = Dark Brown; mid-eastern skin types; Very rarely burns, tans easily\n\nSkin Type VI = Black; Never burns, tans very easily', 'unitOfMeasure': '# of Participants'}], 'populationDescription': 'N=33 Excluded from analysis: N=22 excluded for inclusion criteria/photo lighting/positional/makeup issues and N=11 lost to follow-up.'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 103}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-01', 'completionDateStruct': {'date': '2011-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-11-16', 'studyFirstSubmitDate': '2011-06-06', 'resultsFirstSubmitDate': '2013-03-25', 'studyFirstSubmitQcDate': '2011-06-06', 'lastUpdatePostDateStruct': {'date': '2017-12-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2013-07-15', 'studyFirstPostDateStruct': {'date': '2011-06-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-08-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Subject Assessment of Pain', 'timeFrame': 'During Ulthera study treatment', 'description': "Subject assessment of pain using a validated Numeric Rating Scale (NRS), 0-10, where 0 = no pain and 10=worse pain possible. Subjects' sensory responses to the treatment exposures were recorded using the NRS for each anatomical region."}], 'primaryOutcomes': [{'measure': 'Change in Overall Lifting and Tightening of Treated Tissue on the Lower Face and Submental Regions.', 'timeFrame': '90D', 'description': 'The percentage of participants assessed to have improvement in skin laxity, i.e., lifted and tightened skin in the areas treated with the Ulthera System, as determined by three masked assessors comparing pre-treatment and 90-days post-treatment photos from 70 subjects who returned for their 90-day follow-up visit.'}], 'secondaryOutcomes': [{'measure': 'Change in Submental and Neck Skin Laxity by Quantitative Analysis', 'timeFrame': '90D', 'description': 'The percentage of participants assessed as having an improvement in tissue lift, i.e., \\>20mm2 in submental and neck skin laxity, at 90 Days post-treatment compared to baseline based on quantitative analysis.'}, {'measure': 'Patient Satisfaction Questionnaire', 'timeFrame': '90D', 'description': "Subjects indicated whether they saw improvement, i.e., providing a Yes/No response, in face and neck characteristics at three months (D90) post Ulthera treatment. Pre-treatment and Day 90 post-treatment photographs were available for viewing during the assessment. Subjects also had a mirror in hand for real time assessment. Subjects' Yes/No responses were tabulated."}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Mild to Moderate Skin Laxity on Cheek', 'Mild to Moderate Skin Laxity on Upper Neck', 'Mild to Moderate Subcutaneous Fat on Cheek', 'Mild to Moderate Subcutaneous Fat on Upper Neck']}, 'descriptionModule': {'briefSummary': 'The clinical trial evaluates the clinical outcomes associated with the non-invasive treatment to obtain lift and tightening of the cheek tissue and improve jawline definition and submental skin laxity utilizing the Ulthera™ System which delivers ultrasound energy in a focused manner below the surface of the skin', 'detailedDescription': 'The primary objective of this study is to demonstrate the effectiveness of the Ulthera™ System for the non-invasive dermatological treatment to obtain lift and tighten the cheek tissue.\n\nThe secondary objective of this study is to demonstrate the effectiveness of the Ulthera™ System for the non-invasive dermatological treatment for improvement in jawline definition and submental skin laxity at 3 and 6 months compared to baseline based on the consensus of the three masked reviewers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '35 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female, aged 35 to 60 years\n* Subject in good health\n* Desire lift and tightening of cheek tissue, improvement of jawline definition or submental skin laxity\n\nExclusion Criteria:\n\n* Pregnant or lactating\n* Has an active systemic or local skin disease that may alter wound healing\n* Severe solar elastosis\n* Excessive subcutaneous fat on the cheeks\n* Excessive skin laxity on the lower face and neck\n* Has significant scarring in areas to be treated\n* Has significant open facial wounds or lesions\n* Has severe or cystic acne on the face'}, 'identificationModule': {'nctId': 'NCT01368835', 'briefTitle': 'Evaluation of the Ulthera™ System for Obtaining Lift and Tightening of the Cheek Tissue', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merz North America, Inc.'}, 'officialTitle': 'Evaluation of the Ulthera™ System For Obtaining Lift and Tightening of the Cheek Tissue and Improvement in Jawline Definition and Submental Skin Laxity', 'orgStudyIdInfo': {'id': 'ULT-106'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ulthera treatment', 'interventionNames': ['Device: Ulthera treatment']}], 'interventions': [{'name': 'Ulthera treatment', 'type': 'DEVICE', 'description': 'treatment of cheeks and upper neck area of face', 'armGroupLabels': ['Ulthera treatment']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Jeffrey M. Kenkel, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Texas Southwestern Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ulthera, Inc', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'University of Texas Southwestern Medical Center', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}