Ignite Creation Date:
2025-12-25 @ 3:03 AM
Ignite Modification Date:
2025-12-26 @ 1:43 AM
Study NCT ID:
NCT01713933
Status:
COMPLETED
Last Update Posted:
2017-12-11
First Post:
2012-10-15
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Evaluation of the Ulthera® System for Treatment of the Brachia
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}, 'limitationsAndCaveats': {'description': '\\- Poor subject selection (high BMI with large volume arms enrolled rather than subjects with laxity and wrinkled skin)'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Ultherapy® Treatment', 'description': 'Each enrolled subject will receive a bilateral Ultherapy® treatment of the upper arms', 'otherNumAtRisk': 37, 'otherNumAffected': 0, 'seriousNumAtRisk': 37, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Improvement in Obtaining Lift and Tightening of Brachial Skin Laxity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ultherapy® Treatment', 'description': 'Each enrolled subject will receive a bilateral Ultherapy® treatment of the upper arms'}], 'classes': [{'categories': [{'measurements': [{'value': '48', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to 90 days post-treatment', 'description': 'Improvement in overall lifting and tightening of brachial skin laxity as determined by masked, qualitative assessment of photographs at 90 days post-treatment compared to baseline.', 'unitOfMeasure': 'percentage of participants improved', 'reportingStatus': 'POSTED', 'populationDescription': 'Twenty-seven (27) subjects returned for the 90 day post-treatment visit. Five (5) 90 day visits were missed, including the one subject excluded from analyses as an outlier due to high Body Mass Index (BMI) and substantial weight gain during the study period. Two (2) subjects were lost-to-follow-up.'}, {'type': 'SECONDARY', 'title': 'Quantitative Improvement in Skin Laxity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ultherapy® Treatment', 'description': 'Each enrolled subject will receive a bilateral Ultherapy® treatment of the upper arms'}], 'classes': [{'title': 'Improvement Left Arm', 'categories': [{'measurements': [{'value': '54', 'groupId': 'OG000'}]}]}, {'title': 'Improvement Right Arm', 'categories': [{'measurements': [{'value': '62', 'groupId': 'OG000'}]}]}, {'title': 'Improvement of both Left & Right Arms', 'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to 90 days post-treatment', 'description': 'Assess change in brachial volume based on brachial tissue measurements.', 'unitOfMeasure': 'percentage of participants improved', 'reportingStatus': 'POSTED', 'populationDescription': 'Twenty-seven (27) subjects returned for the 90 day post-treatment visit. Five (5) 90 day visits were missed, including one subject excluded from analyses as an outlier due to high BMI and substantial weight gain during the study period. Two (2) subjects were lost-to-follow-up.'}, {'type': 'SECONDARY', 'title': 'Change in Dermal Thickness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ultherapy® Treatment', 'description': 'Each enrolled subject will receive a bilateral Ultherapy® treatment of the upper arms'}], 'classes': [{'title': 'Difference in Mean Thickness from Baseline - R Arm', 'categories': [{'measurements': [{'value': '0.072', 'groupId': 'OG000', 'lowerLimit': '-0.015', 'upperLimit': '0.224'}]}]}, {'title': 'Difference in Mean Thickness from Baseline - L Arm', 'categories': [{'measurements': [{'value': '0.082', 'groupId': 'OG000', 'lowerLimit': '-0.170', 'upperLimit': '0.296'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 90 days post-treatment', 'description': 'Based on ultrasonic skin analysis, the change in dermal thickness from baseline to 90 days post-treatment was calculated.', 'unitOfMeasure': 'Millimeters', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Twenty-seven (27) subjects returned for the 90 day post-treatment visit. Five (5) 90 day visits were missed, including one subject excluded from analyses as an outlier due to high BMI and substantial weight gain during the study period. Two (2) subjects were lost-to-follow-up.'}, {'type': 'SECONDARY', 'title': 'Change in Dermal Thickness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ultherapy® Treatment', 'description': 'Each enrolled subject will receive a bilateral Ultherapy® treatment of the upper arms'}], 'classes': [{'title': 'Difference in Mean Thickness from Baseline - R Arm', 'categories': [{'measurements': [{'value': '0.099', 'groupId': 'OG000', 'lowerLimit': '0.002', 'upperLimit': '0.330'}]}]}, {'title': 'Difference in Mean Thickness from Baseline - L Arm', 'categories': [{'measurements': [{'value': '0.085', 'groupId': 'OG000', 'lowerLimit': '0.034', 'upperLimit': '0.459'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to180 days post-treatment', 'description': 'Based on ultrasonic skin analysis, the change in dermal thickness from baseline to 180 days post-treatment was calculated.', 'unitOfMeasure': 'Millimeters', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Thirty-one (31) subjects returned for the 180 day post-treatment visit. Two subjects were lost-to-follow-up. One subject was excluded from analyses as an outlier due to high BMI and substantial weight gain during the study period.'}, {'type': 'SECONDARY', 'title': 'Overall Aesthetic Improvement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ultherapy® Treatment', 'description': 'Each enrolled subject will receive a bilateral Ultherapy® treatment of the upper arms'}], 'classes': [{'title': 'Subject GAIS Very Much Improved', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Subject GAIS Much Improved', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Subject GAIS Improved', 'categories': [{'measurements': [{'value': '51.6', 'groupId': 'OG000'}]}]}, {'title': 'Subject GAIS No Change', 'categories': [{'measurements': [{'value': '48.4', 'groupId': 'OG000'}]}]}, {'title': 'Subject GAIS Worse', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Physician GAIS Very Much Improved', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Physician GAIS Much Improved', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Physician GAIS Improved', 'categories': [{'measurements': [{'value': '67.7', 'groupId': 'OG000'}]}]}, {'title': 'Physician GAIS No Change', 'categories': [{'measurements': [{'value': '32.2', 'groupId': 'OG000'}]}]}, {'title': 'Physician GAIS Worse', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to 60 days post-treatment', 'description': 'Based on Global Aesthetic Improvement Scale (GAIS) Scores; PGAIS completed by a physician assessor, SGAIS completed by the study subject. . The GAIS is a 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', 'populationDescription': 'Thirty-one (31) subjects returned for the 60 day post-treatment visit. Two subjects were lost-to-follow-up. One subject was excluded from analyses as an outlier due to high BMI and substantial weight gain during the study period.'}, {'type': 'SECONDARY', 'title': 'Overall Aesthetic Improvement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ultherapy® Treatment', 'description': 'Each enrolled subject will receive a bilateral Ultherapy® treatment of the upper arms'}], 'classes': [{'title': 'Subject GAIS Very Much Improved', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Subject GAIS Much Improved', 'categories': [{'measurements': [{'value': '3.7', 'groupId': 'OG000'}]}]}, {'title': 'Subject GAIS Improved', 'categories': [{'measurements': [{'value': '59.3', 'groupId': 'OG000'}]}]}, {'title': 'Subject GAIS No Change', 'categories': [{'measurements': [{'value': '37.0', 'groupId': 'OG000'}]}]}, {'title': 'Subject GAIS Worse', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Physician GAIS Very Much Improved', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Physician GAIS Much Improved', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Physician GAIS Improved', 'categories': [{'measurements': [{'value': '66.6', 'groupId': 'OG000'}]}]}, {'title': 'Physician GAIS No Change', 'categories': [{'measurements': [{'value': '33.3', 'groupId': 'OG000'}]}]}, {'title': 'Physician GAIS Worse', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to 90 days post-treatment', 'description': 'Based on Global Aesthetic Improvement Scale (GAIS) Scores; PGAIS completed by a physician assessor, SGAIS completed by the study subject. . The GAIS is a 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', 'populationDescription': 'Twenty-seven (27) subjects returned for the 90 day post-treatment visit. Five (5) 90 day visits were missed, including one subject excluded from analyses as an outlier due to high BMI and substantial weight gain during the study period. Two (2) subjects were lost-to-follow-up.'}, {'type': 'SECONDARY', 'title': 'Overall Aesthetic Improvement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ultherapy® Treatment', 'description': 'Each enrolled subject will receive a bilateral Ultherapy® treatment of the upper arms'}], 'classes': [{'title': 'Subject GAIS Very Much Improved', 'categories': [{'measurements': [{'value': '6.5', 'groupId': 'OG000'}]}]}, {'title': 'Subject GAIS Much Improved', 'categories': [{'measurements': [{'value': '16.1', 'groupId': 'OG000'}]}]}, {'title': 'Subject GAIS Improved', 'categories': [{'measurements': [{'value': '48.4', 'groupId': 'OG000'}]}]}, {'title': 'Subject GAIS No Change', 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}]}]}, {'title': 'Subject GAIS Worse', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Physician GAIS Very Much Improved', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Physician GAIS Much Improved', 'categories': [{'measurements': [{'value': '19.4', 'groupId': 'OG000'}]}]}, {'title': 'Physician GAIS Improved', 'categories': [{'measurements': [{'value': '61.3', 'groupId': 'OG000'}]}]}, {'title': 'Physician GAIS No Change', 'categories': [{'measurements': [{'value': '19.4', 'groupId': 'OG000'}]}]}, {'title': 'Physician GAIS Worse', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to180 days post-treatment', 'description': 'Based on Global Aesthetic Improvement Scale (GAIS) Scores; PGAIS completed by a physician assessor, SGAIS completed by the study subject. . The GAIS is a 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', 'populationDescription': 'Thirty-one (31) subjects returned for the 180 day post-treatment visit. Two subjects were lost-to-follow-up. One subject was excluded from analyses as an outlier due to high BMI and substantial weight gain during the study period.'}, {'type': 'SECONDARY', 'title': 'Patient Satisfaction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ultherapy® Treatment', 'description': 'Each enrolled subject will receive a bilateral Ultherapy® treatment of the upper arms'}], 'classes': [{'title': 'Very Satisfied', 'categories': [{'measurements': [{'value': '14.8', 'groupId': 'OG000'}]}]}, {'title': 'Satisfied', 'categories': [{'measurements': [{'value': '59.2', 'groupId': 'OG000'}]}]}, {'title': 'Dissatisfied', 'categories': [{'measurements': [{'value': '22.2', 'groupId': 'OG000'}]}]}, {'title': 'Very Dissatisfied', 'categories': [{'measurements': [{'value': '3.7', 'groupId': 'OG000'}]}]}, {'title': 'Improvement Noticed', 'categories': [{'measurements': [{'value': '55.5', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to 90 days post-treatment', 'description': 'Patient satisfaction was determined by scores on a patient satisfaction questionnaire (PSQ) completed at 90 days post-treatment. Subjects indicated how satisfied they were with study treatment, i.e., Very Satisfied, Satisfied, Dissatisfied, Very Dissatisfied. Pre-treatment and Day 90 post-treatment photographs were available for viewing during the assessment.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'wenty-seven (27) subjects returned for the 90 day post-treatment visit. Five (5) 90 day visits were missed, including one subject excluded from analyses as an outlier due to high BMI and substantial weight gain during the study period. Two (2) subjects were lost-to-follow-up.'}, {'type': 'SECONDARY', 'title': 'Patient Satisfaction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ultherapy® Treatment', 'description': 'Each enrolled subject will receive a bilateral Ultherapy® treatment of the upper arms'}], 'classes': [{'title': 'Very Satisfied', 'categories': [{'measurements': [{'value': '12.9', 'groupId': 'OG000'}]}]}, {'title': 'Satisfied', 'categories': [{'measurements': [{'value': '64.5', 'groupId': 'OG000'}]}]}, {'title': 'Dissatisfied', 'categories': [{'measurements': [{'value': '22.5', 'groupId': 'OG000'}]}]}, {'title': 'Very Dissatisfied', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Improvement Noticed', 'categories': [{'measurements': [{'value': '70.9', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to 180 days post-treatment', 'description': 'Patient satisfaction was determined by scores on a patient satisfaction questionnaire (PSQ) completed at 180 days post-treatment. Subjects indicated how satisfied they were with study treatment, i.e., Very Satisfied, Satisfied, Dissatisfied, Very Dissatisfied. Pre-treatment and Day 90 post-treatment photographs were available for viewing during the assessment.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Thirty-one (31) subjects returned for the 180 day post-treatment visit. Two subjects were lost-to-follow-up. One subject was excluded from analyses as an outlier due to high BMI and substantial weight gain during the study period.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Ultherapy® Treatment', 'description': 'Each enrolled subject will receive a bilateral Ultherapy® treatment of the upper arms'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '37'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '31'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'Excluded from analysis as a BMI outlier', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}], 'recruitmentDetails': "Enrollment opened 6/29/2011 and the last subject was treated 11/28/2011. Subjects were recruited from the site's patient database."}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Ultherapy® Treatment', 'description': 'Each enrolled subject will receive a bilateral Ultherapy® treatment of the upper arms'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '40', 'groupId': 'BG000', 'lowerLimit': '25', 'upperLimit': '57'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '33', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '33', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Fitzpatrick Skin Type', 'classes': [{'title': 'Type I', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}, {'title': 'Type II', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}, {'title': 'Type III', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}]}]}, {'title': 'Type IV', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}]}]}, {'title': 'Type V', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}, {'title': 'Type VI', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': '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', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Three subjects excluded due to subject withdrawal. One subject excluded from results analyses as an outlier, with a high Body Mass Index (BMI) and substantial weight gain during the study period.'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 37}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-11', 'completionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-11-10', 'studyFirstSubmitDate': '2012-10-15', 'resultsFirstSubmitDate': '2014-01-13', 'studyFirstSubmitQcDate': '2012-10-22', 'lastUpdatePostDateStruct': {'date': '2017-12-11', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2014-04-25', 'studyFirstPostDateStruct': {'date': '2012-10-25', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-05-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Improvement in Obtaining Lift and Tightening of Brachial Skin Laxity', 'timeFrame': 'Baseline to 90 days post-treatment', 'description': 'Improvement in overall lifting and tightening of brachial skin laxity as determined by masked, qualitative assessment of photographs at 90 days post-treatment compared to baseline.'}], 'secondaryOutcomes': [{'measure': 'Quantitative Improvement in Skin Laxity', 'timeFrame': 'Baseline to 90 days post-treatment', 'description': 'Assess change in brachial volume based on brachial tissue measurements.'}, {'measure': 'Change in Dermal Thickness', 'timeFrame': 'Baseline to 90 days post-treatment', 'description': 'Based on ultrasonic skin analysis, the change in dermal thickness from baseline to 90 days post-treatment was calculated.'}, {'measure': 'Change in Dermal Thickness', 'timeFrame': 'Baseline to180 days post-treatment', 'description': 'Based on ultrasonic skin analysis, the change in dermal thickness from baseline to 180 days post-treatment was calculated.'}, {'measure': 'Overall Aesthetic Improvement', 'timeFrame': 'Baseline to 60 days post-treatment', 'description': 'Based on Global Aesthetic Improvement Scale (GAIS) Scores; PGAIS completed by a physician assessor, SGAIS completed by the study subject. . The GAIS is a 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': 'Overall Aesthetic Improvement', 'timeFrame': 'Baseline to 90 days post-treatment', 'description': 'Based on Global Aesthetic Improvement Scale (GAIS) Scores; PGAIS completed by a physician assessor, SGAIS completed by the study subject. . The GAIS is a 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': 'Overall Aesthetic Improvement', 'timeFrame': 'Baseline to180 days post-treatment', 'description': 'Based on Global Aesthetic Improvement Scale (GAIS) Scores; PGAIS completed by a physician assessor, SGAIS completed by the study subject. . The GAIS is a 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': 'Patient Satisfaction', 'timeFrame': 'Baseline to 90 days post-treatment', 'description': 'Patient satisfaction was determined by scores on a patient satisfaction questionnaire (PSQ) completed at 90 days post-treatment. Subjects indicated how satisfied they were with study treatment, i.e., Very Satisfied, Satisfied, Dissatisfied, Very Dissatisfied. Pre-treatment and Day 90 post-treatment photographs were available for viewing during the assessment.'}, {'measure': 'Patient Satisfaction', 'timeFrame': 'Baseline to 180 days post-treatment', 'description': 'Patient satisfaction was determined by scores on a patient satisfaction questionnaire (PSQ) completed at 180 days post-treatment. Subjects indicated how satisfied they were with study treatment, i.e., Very Satisfied, Satisfied, Dissatisfied, Very Dissatisfied. Pre-treatment and Day 90 post-treatment photographs were available for viewing during the assessment.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Ulthera® System', 'Ultherapy™ treatment', 'Ulthera, Inc.'], 'conditions': ['Brachial Ptosis']}, 'descriptionModule': {'briefSummary': 'This study is an evaluation of the Ulthera® System used to treat the upper arms for improvement of brachial ptosis. All enrolled subjects will receive one bilateral upper arm treatment. Follow-up visits will occur at 60, 90 and 180 days post-treatment.', 'detailedDescription': 'This is a prospective, non-randomized, clinical trial treating up to 35 subjects. Study photographs of the upper arms will be taken prior to treatment, immediately post-treatment, and at each follow-up visit. Brachial volume and dermal thickness measurements will be obtained.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female, aged 19 - 55 years.\n* Subject in good health.\n* Subjects who desire lift and tightening of the brachia and improvement in skin laxity.\n* Mild to moderate laxity of the upper arm.\n* Mild to moderate subcutaneous fat of the upper arm.\n* Mild crepiness of the skin of the upper arm.\n* Understands and accepts the obligation not to undergo any other procedures in the areas to be treated through the follow-up period.\n* Willingness 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\n* Presence of an active systemic or local skin disease that may affect wound healing.\n* Severe solar elastosis.\n* Excessive subcutaneous fat in the upper arm.\n* Excessive skin laxity in the upper arm.\n* Significant scarring in areas to be treated.\n* Significant open wounds or lesions in the treatment areas. 7. Severe or cystic acne in the treatment areas.'}, 'identificationModule': {'nctId': 'NCT01713933', 'briefTitle': 'Evaluation of the Ulthera® System for Treatment of the Brachia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merz North America, Inc.'}, 'officialTitle': 'Evaluation of the Ulthera® System for Obtaining Lift and Tightening of the Brachia', 'orgStudyIdInfo': {'id': 'ULT-114'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ultherapy™ treatment', 'description': 'Each enrolled subject will receive a bilateral Ultherapy™ treatment of the upper arms', 'interventionNames': ['Device: Ulthera® System']}], 'interventions': [{'name': 'Ulthera® System', 'type': 'DEVICE', 'otherNames': ['Ultherapy™ treatment', 'Ulthera, Inc.', 'Ultrasound treatment for skin tightening'], 'description': 'Focused ultrasound energy delivered below the surface of the skin.', 'armGroupLabels': ['Ultherapy™ treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91105', 'city': 'Pasadena', 'state': 'California', 'country': 'United States', 'facility': 'Sasaki Advanced Aesthetic Medical Center', 'geoPoint': {'lat': 34.14778, 'lon': -118.14452}}], 'overallOfficials': [{'name': 'Gordon Sasaki, MD FACS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sasaki Advanced Aesthetic Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ulthera, Inc', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}