{ "FullStudy":{ "Rank":217606, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01519206", "OrgStudyIdInfo":{ "OrgStudyId":"ULT-124" }, "Organization":{ "OrgFullName":"Merz North America, Inc.", "OrgClass":"INDUSTRY" }, "BriefTitle":"Lifting and Tightening of the Face and Neck Following an Increased Density Treatment", "OfficialTitle":"Evaluation of the Efficacy and Safety of the Ulthera® System for Lifting and Tightening of the Face and Neck Following an Increased Density Treatment." }, "StatusModule":{ "StatusVerifiedDate":"November 2017", "OverallStatus":"Completed", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"August 2011" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"February 2012", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"March 2013", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"December 8, 2011", "StudyFirstSubmitQCDate":"January 25, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 26, 2012", "StudyFirstPostDateType":"Estimate" }, "ResultsFirstSubmitDate":"March 20, 2014", "ResultsFirstSubmitQCDate":"May 22, 2014", "ResultsFirstPostDateStruct":{ "ResultsFirstPostDate":"June 2, 2014", "ResultsFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"November 10, 2017", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"December 11, 2017", "LastUpdatePostDateType":"Actual" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Sponsor" }, "LeadSponsor":{ "LeadSponsorName":"Ulthera, Inc", "LeadSponsorClass":"INDUSTRY" } }, "OversightModule":{ "OversightHasDMC":"No" }, "DescriptionModule":{ "BriefSummary":"The purpose of this study is to evaluate the Ulthera® System for obtaining lift and tightening of the cheek tissue, reduction of jowling, and improving jawline definition and/or submental skin laxity when increased density treatment is applied.", "DetailedDescription":"All enrolled study subjects will receive one full face and neck Ultherapy™ treatment. Pre- and post-treatment photos will be taken. Subjects will be required to return for follow-up visits at 60 days, 90 days, 180 days and 1 year following treatment." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Skin Laxity" ] }, "KeywordList":{ "Keyword":[ "Ulthera® System", "Ultherapy™ Treatment", "Ulthera, Inc." ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Not Applicable" ] }, "DesignInfo":{ "DesignInterventionModel":"Single Group Assignment", "DesignPrimaryPurpose":"Treatment", "DesignMaskingInfo":{ "DesignMasking":"None (Open Label)" } }, "EnrollmentInfo":{ "EnrollmentCount":"32", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"Ultherapy treatment", "ArmGroupType":"Experimental", "ArmGroupDescription":"Ulthera System Treatment", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Device: Ulthera System Treatment" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Device", "InterventionName":"Ulthera System Treatment", "InterventionDescription":"Focused ultrasound energy delivered below the surface of the skin.", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Ultherapy treatment" ] }, "InterventionOtherNameList":{ "InterventionOtherName":[ "Ultherapy™", "Ulthera, Inc.", "Ultrasound treatment for skin tightening" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Improvement in Overall Lifting and Tightening of Skin", "PrimaryOutcomeDescription":"Improvement in overall lifting and tightening of skin was completed by three masked assessors, completing a qualitative assessment of pre- and post-treatment photographs. Masked photo pairs of pre/post treatment photos of each treated subject were provided to each assessor. Each photo pair was consistent in lighting, position, focus. The visit interval of each photo was NOT marked. Each assessor's review was completed independently, with no input from others, assessing the photos for improvement. If improvement was seen, the blinded assessor was to choose the post-treatment photo. Categories of assessment included Improved, No Change, or Incorrect post-treatment photo chosen. The majority assessment among the 3 blinded assessors for each subject was reported.", "PrimaryOutcomeTimeFrame":"Baseline to 90 days post treatment" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"Overall Aesthetic Improvement at 60 Days, 90 Days, 180 Days and 1 Year Post-treatment.", "SecondaryOutcomeDescription":"Improvement was assessed based on Global Aesthetic Improvement Scale (GAIS) scores. The GAIS was completed based on a live assessment of the subject and a photographic assessment comparing post-treatment photos to baseline photos. The PGAIS was completed by a clinician assessor; SGAIS was completed by the study subject. The GAIS is a 5-point scale (1-5) describing an overall assessment as follows:\n\n- Very Much Improved\n- Much Improved\n- Improved\n- No Change\n- Worse", "SecondaryOutcomeTimeFrame":"Baseline to 60 days, 90 days, 180 days and 1 year post-treatment" },{ "SecondaryOutcomeMeasure":"Subjects' Assessment of Pain", "SecondaryOutcomeDescription":"Subjects' sensory response to the Ulthera treatment exposures were recorded for each anatomical region treated using a validated Numeric Rating Scale (0-10), with 1 representing no pain and 10 representing the worst pain possible. Subjects rated pain for each transducer, in each treatment region. For statistical analyses, NRS scores were averaged for each transducer depth.", "SecondaryOutcomeTimeFrame":"During Ulthera treatment" },{ "SecondaryOutcomeMeasure":"Subject Satisfaction at 90 Days, 180 Days and 1 Year Post-treatment", "SecondaryOutcomeDescription":"Subject satisfaction was determined by scores on a patient satisfaction questionnaire (PSQ) completed at 90 days, 180 days and 1 year post-treatment. Subjects indicated how satisfied they were with their study treatment, i.e., Very Satisfied, Satisfied, Dissatisfied, Very Dissatisfied. Pre-treatment and post-treatment photographs were available for viewing at each follow-up visit interval. Subjects also had a mirror available for real time assessment, comparing their image in the mirror with pre-treatment and post-treatment photos.", "SecondaryOutcomeTimeFrame":"Baseline to 90 days, 180 days and 1 year post-treatment" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nMale or female, aged 30 to 65 years\nSubject in good health\nDesires lift and tightening of cheek tissue, reduction of jowling, improvement of jawline definition and/or submental skin laxity\nUnderstands and accepts the obligation not to undergo any other procedures in the areas to be treated through the followup period\nWillingness and ability to comply with protocol requirements, including returning for follow-up visits and abstaining from exclusionary procedures for the duration of the study\n\nExclusion Criteria:\n\nPresence of an active systemic or local skin disease that may affect wound healing\nSevere solar elastosis\nExcessive subcutaneous fat on the cheeks\nExcessive skin laxity on the lower face and neck\nSignificant scarring in areas to be treated\nSignificant open facial wounds or lesions\nSevere or cystic acne on the face\nPresence of a metal stent or implant in the facial area to be treated, a pacemaker, or cochlear implants", "HealthyVolunteers":"Accepts Healthy Volunteers", "Gender":"All", "MinimumAge":"30 Years", "MaximumAge":"65 Years", "StdAgeList":{ "StdAge":[ "Adult", "Older Adult" ] } }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"Roy Geronemus, M.D.", "OverallOfficialAffiliation":"Laser & Skin Surgery Center of NY", "OverallOfficialRole":"Principal Investigator" } ] }, "LocationList":{ "Location":[ { "LocationFacility":"Laser & Skin Surgery Center of NY", "LocationCity":"New York", "LocationState":"New York", "LocationZip":"10016", "LocationCountry":"United States" } ] } } }, "ResultsSection":{ "ParticipantFlowModule":{ "FlowRecruitmentDetails":"Thirty-five (35) subjects were enrolled, 3 were deemed screen failures. Thirty-two (32) received study treatment. The first subject was treated on August 3, 2011 and the last subject was treated on 11/28/2011. The last patient follow-up for the trial was 11/21/2012.", "FlowGroupList":{ "FlowGroup":[ { "FlowGroupId":"FG000", "FlowGroupTitle":"Ultherapy Treatment", "FlowGroupDescription":"Study subjects received a full face Ultherapy treatment delivering approximately 500 treatment lines at two treatment depths, i.e., 4.5mm and 3.0mm depth." } ] }, "FlowPeriodList":{ "FlowPeriod":[ { "FlowPeriodTitle":"Overall Study", "FlowMilestoneList":{ "FlowMilestone":[ { "FlowMilestoneType":"STARTED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"32" } ] } },{ "FlowMilestoneType":"COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"27" } ] } },{ "FlowMilestoneType":"NOT COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"5" } ] } } ] }, "FlowDropWithdrawList":{ "FlowDropWithdraw":[ { "FlowDropWithdrawType":"Lost to Follow-up", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"3" } ] } },{ "FlowDropWithdrawType":"Missed Visit", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"2" } ] } } ] } } ] } }, "BaselineCharacteristicsModule":{ "BaselineGroupList":{ "BaselineGroup":[ { "BaselineGroupId":"BG000", "BaselineGroupTitle":"Ultherapy Treatment", "BaselineGroupDescription":"Study subjects received a full face Ultherapy treatment delivering approximately 500 treatment lines at two treatment depths, i.e., 4.5mm and 3.0mm depth." } ] }, "BaselineDenomList":{ "BaselineDenom":[ { "BaselineDenomUnits":"Participants", "BaselineDenomCountList":{ "BaselineDenomCount":[ { "BaselineDenomCountGroupId":"BG000", "BaselineDenomCountValue":"32" } ] } } ] }, "BaselineMeasureList":{ "BaselineMeasure":[ { "BaselineMeasureTitle":"Age, Continuous", "BaselineMeasureParamType":"Mean", "BaselineMeasureDispersionType":"Full Range", "BaselineMeasureUnitOfMeasure":"years", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"55", "BaselineMeasurementLowerLimit":"44", "BaselineMeasurementUpperLimit":"64" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Sex: Female, Male", "BaselineMeasureParamType":"Count of Participants", "BaselineMeasureUnitOfMeasure":"Participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineCategoryTitle":"Female", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"31" } ] } },{ "BaselineCategoryTitle":"Male", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"1" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Race/Ethnicity, Customized", "BaselineMeasureParamType":"Number", "BaselineMeasureUnitOfMeasure":"participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineClassTitle":"Caucasian", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"30" } ] } } ] } },{ "BaselineClassTitle":"African American/Black", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"1" } ] } } ] } },{ "BaselineClassTitle":"Hispanic/Latino", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"1" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Region of Enrollment", "BaselineMeasureParamType":"Number", "BaselineMeasureUnitOfMeasure":"participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineClassTitle":"United States", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"32" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Fitzpatrick Skin Type", "BaselineMeasureDescription":"Skin Type I = White; very fair, red or blonde hair blue eyes; freckles; Always burns, never tans Skin Type II = White, fair, red or blond hair; blue, hazel or green eyes; Usually burns, tans with difficulty Skin Type III = Cream white; fair with any eye or hair color (common); Sometimes mild burn, gradually tans Skin Type IV = Brown; typical Mediterranean Caucasian skin; Rarely burns, tans with ease Skin Type V = Dark Brown; mid-eastern skin types; Very rarely burns, tans easily Skin Type VI = Black; Never burns, tans very easily", "BaselineMeasureParamType":"Number", "BaselineMeasureUnitOfMeasure":"participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineClassTitle":"I", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"1" } ] } } ] } },{ "BaselineClassTitle":"II", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"24" } ] } } ] } },{ "BaselineClassTitle":"III", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"6" } ] } } ] } },{ "BaselineClassTitle":"IV", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"0" } ] } } ] } },{ "BaselineClassTitle":"V", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"1" } ] } } ] } },{ "BaselineClassTitle":"VI", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"0" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Body Mass Index (BMI)", "BaselineMeasureParamType":"Mean", "BaselineMeasureDispersionType":"Full Range", "BaselineMeasureUnitOfMeasure":"kg/m˄2", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"23.3", "BaselineMeasurementLowerLimit":"18.0", "BaselineMeasurementUpperLimit":"30.2" } ] } } ] } } ] } } ] } }, "OutcomeMeasuresModule":{ "OutcomeMeasureList":{ "OutcomeMeasure":[ { "OutcomeMeasureType":"Primary", "OutcomeMeasureTitle":"Improvement in Overall Lifting and Tightening of Skin", "OutcomeMeasureDescription":"Improvement in overall lifting and tightening of skin was completed by three masked assessors, completing a qualitative assessment of pre- and post-treatment photographs. Masked photo pairs of pre/post treatment photos of each treated subject were provided to each assessor. Each photo pair was consistent in lighting, position, focus. The visit interval of each photo was NOT marked. Each assessor's review was completed independently, with no input from others, assessing the photos for improvement. If improvement was seen, the blinded assessor was to choose the post-treatment photo. Categories of assessment included Improved, No Change, or Incorrect post-treatment photo chosen. The majority assessment among the 3 blinded assessors for each subject was reported.", "OutcomeMeasurePopulationDescription":"Thirty-five (35) subjects were enrolled; 3 were screen failures. Thirty-two (32) subjects received study treatment. Three (3) subjects were lost-to-follow-up.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureUnitOfMeasure":"percentage of participants improved", "OutcomeMeasureTimeFrame":"Baseline to 90 days post treatment", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Ultherapy Treatment", "OutcomeGroupDescription":"Study subjects received a full face Ultherapy treatment delivering approximately 500 treatment lines at two treatment depths, i.e., 4.5mm and 3.0mm depth." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"29" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"48" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Overall Aesthetic Improvement at 60 Days, 90 Days, 180 Days and 1 Year Post-treatment.", "OutcomeMeasureDescription":"Improvement was assessed based on Global Aesthetic Improvement Scale (GAIS) scores. The GAIS was completed based on a live assessment of the subject and a photographic assessment comparing post-treatment photos to baseline photos. The PGAIS was completed by a clinician assessor; SGAIS was completed by the study subject. The GAIS is a 5-point scale (1-5) describing an overall assessment as follows:\n\n- Very Much Improved\n- Much Improved\n- Improved\n- No Change\n- Worse", "OutcomeMeasurePopulationDescription":"Three (3) subjects were lost-to-follow-up. Two (2) additional subjects missed the 1 year visit.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureUnitOfMeasure":"Percentage of Participants", "OutcomeMeasureTimeFrame":"Baseline to 60 days, 90 days, 180 days and 1 year post-treatment", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Treated Subjects GAIS Data - 60 Days Post-treatment", "OutcomeGroupDescription":"Study subjects received a full face Ultherapy treatment delivering approximately 500 treatment lines at two treatment depths, i.e., 4.5mm and 3.0mm depth." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Treated Subjects GAIS Data - 90 Days Post-treatment", "OutcomeGroupDescription":"Study subjects received a full face Ultherapy treatment delivering approximately 500 treatment lines at two treatment depths, i.e., 4.5mm and 3.0mm depth." },{ "OutcomeGroupId":"OG002", "OutcomeGroupTitle":"Treated Subjects GAIS Data - 180 Days Post-treatment", "OutcomeGroupDescription":"Study subjects received a full face Ultherapy treatment delivering approximately 500 treatment lines at two treatment depths, i.e., 4.5mm and 3.0mm depth." },{ "OutcomeGroupId":"OG003", "OutcomeGroupTitle":"Treated Subjects GAIS Data - 1 Year Post-treatment", "OutcomeGroupDescription":"Study subjects received a full face Ultherapy treatment delivering approximately 500 treatment lines at two treatment depths, i.e., 4.5mm and 3.0mm depth." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"29" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"29" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"29" },{ "OutcomeDenomCountGroupId":"OG003", "OutcomeDenomCountValue":"27" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"PGAIS - Very Much Improved", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"7" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"14" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"7" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"7" } ] } } ] } },{ "OutcomeClassTitle":"PGAIS - Much Improved", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"28" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"24" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"10" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"22" } ] } } ] } },{ "OutcomeClassTitle":"PGAIS - Improved", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"59" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"41" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"48" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"70" } ] } } ] } },{ "OutcomeClassTitle":"PGAIS - No Change", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"7" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"21" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"31" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"PGAIS - Worse", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"3" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"SGAIS - Very Much Improved", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"3" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"3" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"4" } ] } } ] } },{ "OutcomeClassTitle":"SGAIS - Much Improved", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"10" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"17" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"17" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"7" } ] } } ] } },{ "OutcomeClassTitle":"SGAIS - Improved", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"48" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"41" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"52" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"41" } ] } } ] } },{ "OutcomeClassTitle":"SGAIS - No Change", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"34" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"34" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"24" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"41" } ] } } ] } },{ "OutcomeClassTitle":"SGAIS - Worse", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"3" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"3" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"7" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"7" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Subjects' Assessment of Pain", "OutcomeMeasureDescription":"Subjects' sensory response to the Ulthera treatment exposures were recorded for each anatomical region treated using a validated Numeric Rating Scale (0-10), with 1 representing no pain and 10 representing the worst pain possible. Subjects rated pain for each transducer, in each treatment region. For statistical analyses, NRS scores were averaged for each transducer depth.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Full Range", "OutcomeMeasureUnitOfMeasure":"Units on a scale", "OutcomeMeasureTimeFrame":"During Ulthera treatment", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Ultherapy Treatment", "OutcomeGroupDescription":"Study subjects received a full face Ultherapy treatment delivering approximately 500 treatment lines at two treatment depths, i.e., 4.5mm and 3.0mm depth." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"32" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"4.5mm Transducer", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"4.6", "OutcomeMeasurementLowerLimit":"0", "OutcomeMeasurementUpperLimit":"9" } ] } } ] } },{ "OutcomeClassTitle":"3.0mm Transducer", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"3.6", "OutcomeMeasurementLowerLimit":"0", "OutcomeMeasurementUpperLimit":"7" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Subject Satisfaction at 90 Days, 180 Days and 1 Year Post-treatment", "OutcomeMeasureDescription":"Subject satisfaction was determined by scores on a patient satisfaction questionnaire (PSQ) completed at 90 days, 180 days and 1 year post-treatment. Subjects indicated how satisfied they were with their study treatment, i.e., Very Satisfied, Satisfied, Dissatisfied, Very Dissatisfied. Pre-treatment and post-treatment photographs were available for viewing at each follow-up visit interval. Subjects also had a mirror available for real time assessment, comparing their image in the mirror with pre-treatment and post-treatment photos.", "OutcomeMeasurePopulationDescription":"Three (3) subjects were lost-to-follow-up. Two (2) subjects missed the 1 year visit.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureUnitOfMeasure":"Percentage of Participants", "OutcomeMeasureTimeFrame":"Baseline to 90 days, 180 days and 1 year post-treatment", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Treated Subjects PSQ Data - 90 Days Post-treatment", "OutcomeGroupDescription":"Study subjects received a full face Ultherapy treatment delivering approximately 500 treatment lines at two treatment depths, i.e., 4.5mm and 3.0mm depth." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Treated Subjects PSQ Data - 180 Days Post-treatment", "OutcomeGroupDescription":"Study subjects received a full face Ultherapy treatment delivering approximately 500 treatment lines at two treatment depths, i.e., 4.5mm and 3.0mm depth." },{ "OutcomeGroupId":"OG002", "OutcomeGroupTitle":"Treated Subjects PSQ Data - 1 Year Post-treatment", "OutcomeGroupDescription":"Study subjects received a full face Ultherapy treatment delivering approximately 500 treatment lines at two treatment depths, i.e., 4.5mm and 3.0mm depth." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"29" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"29" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"27" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"Very Satisfied", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"21" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"10" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"7" } ] } } ] } },{ "OutcomeClassTitle":"Satisfied", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"48" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"59" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"41" } ] } } ] } },{ "OutcomeClassTitle":"Dissatisfied", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"24" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"21" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"37" } ] } } ] } },{ "OutcomeClassTitle":"Very Dissatisfied", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"7" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"10" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"15" } ] } } ] } } ] } } ] } }, "AdverseEventsModule":{ "EventsFrequencyThreshold":"5", "EventsTimeFrame":"Adverse events were assessed during the entire study period, i.e., 1 year post-treatment.", "EventGroupList":{ "EventGroup":[ { "EventGroupId":"EG000", "EventGroupTitle":"Ultherapy Treatment", "EventGroupDescription":"Study subjects received a full face Ultherapy treatment delivering approximately 500 treatment lines at two treatment depths, i.e., 4.5mm and 3.0mm depth.", "EventGroupSeriousNumAffected":"0", "EventGroupSeriousNumAtRisk":"32", "EventGroupOtherNumAffected":"0", "EventGroupOtherNumAtRisk":"32" } ] } }, "MoreInfoModule":{ "LimitationsAndCaveats":{}, "CertainAgreement":{ "AgreementPISponsorEmployee":"No", "AgreementRestrictiveAgreement":"No" }, "PointOfContact":{ "PointOfContactTitle":"Public Disclosure Manager", "PointOfContactOrganization":"Merz Pharmaceuticals", "PointOfContactEMail":"clinicaltrials@merz.com" } } }, "DerivedSection":{ 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