Ignite Creation Date:
2025-12-24 @ 9:09 PM
Ignite Modification Date:
2025-12-31 @ 12:48 PM
Study NCT ID:
NCT05067504
Status:
COMPLETED
Last Update Posted:
2025-10-15
First Post:
2021-09-22
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effectiveness and Safety of the Octave System for Lifting the Eyebrow and Improving the Appearance of the Face and Neck
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2025-09-04', 'type': 'ESTIMATED'}}}}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Aesthetic.Trials@merz.com', 'phone': '+1 984-301-3095', 'title': 'Public Disclosure Manager', 'organization': 'Merz Aesthetics'}, 'certainAgreement': {'otherDetails': 'Publication of study information usually requires agreement with the sponsor. In case of justified doubts by the sponsor, the INVESTIGATOR will consider these doubts in the publication as long as the scientific neutrality is not affected.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From first treatment on Day 1 up to the end of study on Day 180 (an average of 6 months)', 'description': 'SP. The investigator reported AEs systematically at each visit.', 'eventGroups': [{'id': 'EG000', 'title': 'Stage 1: Octave-Ultherapy Treatment', 'description': 'Subjects received a single Octave-Ultherapy treatment of the brow, face, and neck on Day 1 of Stage 1 with two transducers.', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 5, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Stage 2: Octave-Ultherapy Treatment', 'description': 'Subjects received a single Octave-Ultherapy treatment of the brow, face, and neck on Day 1 of Stage 2 with up to four transducers.', 'otherNumAtRisk': 40, 'deathsNumAtRisk': 40, 'otherNumAffected': 5, 'seriousNumAtRisk': 40, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Application site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 40, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Application site pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 40, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Application site urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 40, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Application site discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 40, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Application site dysaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 40, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 40, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 40, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}], 'seriousEvents': [{'term': 'Follicular lymphoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 40, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Treated Subjects With Eyebrow Lift at Day 90', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 1: Octave-Ultherapy Treatment', 'description': 'Subjects received a single Octave-Ultherapy treatment of the brow, face, and neck on Day 1 of Stage 1 with two transducers.'}, {'id': 'OG001', 'title': 'Stage 2: Octave-Ultherapy Treatment"', 'description': 'Subjects received a single Octave-Ultherapy treatment of the brow, face, and neck on Day 1 of Stage 2 with up to four transducers.'}], 'classes': [{'categories': [{'measurements': [{'value': '80.0', 'groupId': 'OG000'}, {'value': '67.5', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 90', 'description': 'Improvement in eyebrow lift was determined by three evaluators after comparing Day 90 photographs with baseline photographs. Lift was concluded if at least two evaluators reported "eyebrow lift" in the Day 90 photographs as compared to baseline.', 'unitOfMeasure': 'percentage of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat (ITT) population included all subjects who were enrolled.'}, {'type': 'SECONDARY', 'title': 'Percentage of Treated Subjects With Eyebrow Lift at Day 180', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 1: Octave-Ultherapy Treatment"', 'description': 'Subjects received a single Octave-Ultherapy treatment of the brow, face, and neck on Day 1 of Stage 1 with two transducers.'}, {'id': 'OG001', 'title': 'Stage 2: Octave-Ultherapy Treatment"', 'description': 'Subjects received a single Octave-Ultherapy treatment of the brow, face, and neck on Day 1 of Stage 2 with up to four transducers.'}], 'classes': [{'categories': [{'measurements': [{'value': '81.7', 'groupId': 'OG000'}, {'value': '64.7', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 180', 'description': 'Improvement in eyebrow lift was determined by three evaluators after comparing Day 180 photographs with baseline photographs. Lift was concluded if at least two evaluators reported "eyebrow lift" in the Day 180 photographs as compared to baseline.', 'unitOfMeasure': 'percentage of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT. Here "overall number of subjects analyzed" were subjects who were eligible for this outcome measure. The results for this outcome measure across both stages were estimated using the ITT population with multiple imputations.'}, {'type': 'SECONDARY', 'title': 'Percentage of Treated Subjects With Eyebrow Lift of at Least 0.5 Millimeter (mm) at Day 90 and Day 180', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 1: Octave-Ultherapy Treatment', 'description': 'Subjects received a single Octave-Ultherapy treatment of the brow, face, and neck on Day 1 of Stage 1 with two transducers.'}, {'id': 'OG001', 'title': 'Stage 2: Octave-Ultherapy Treatment', 'description': 'Subjects received a single Octave-Ultherapy treatment of the brow, face, and neck on Day 1 of Stage 2 with up to four transducers.'}], 'classes': [{'title': 'Day 90', 'categories': [{'measurements': [{'value': '20.0', 'groupId': 'OG000'}, {'value': '27.5', 'groupId': 'OG001'}]}]}, {'title': 'Day 180', 'categories': [{'measurements': [{'value': '16.7', 'groupId': 'OG000'}, {'value': '30.8', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 90 and Day 180', 'description': "Eyebrow lift position on frontal view was measured by calculating the differences in eyebrow height. Standard images of the subject's face were collected before treatment, and at Day 90 and Day 180 to visualize and quantify changes in the treated regions.", 'unitOfMeasure': 'percentage of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in FACE-Q Satisfaction With Forehead and Eyebrows Score (Rasch-transformed) at Day 90 and Day 180, as Assessed by Subject', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 1: Octave-Ultherapy Treatment', 'description': 'Subjects received a single Octave-Ultherapy treatment of the brow, face, and neck on Day 1 of Stage 1 with two transducers.'}, {'id': 'OG001', 'title': 'Stage 2: Octave-Ultherapy Treatment', 'description': 'Subjects received a single Octave-Ultherapy treatment of the brow, face, and neck on Day 1 of Stage 2 with up to four transducers.'}], 'classes': [{'title': 'Day 90', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10.1', 'spread': '33.27', 'groupId': 'OG000'}, {'value': '21.1', 'spread': '22.12', 'groupId': 'OG001'}]}]}, {'title': 'Day 180', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '20.5', 'spread': '11.48', 'groupId': 'OG000'}, {'value': '22.7', 'spread': '20.51', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At Baseline, Day 90 and Day 180', 'description': 'The FACE-Q is a set of standardized patient-reported outcome scales for subjects undergoing facial cosmetic procedures. The subject assessed satisfaction using the Face-Q Satisfaction with Forehead and Eyebrows module (1 \\[very dissatisfied\\] to 4 \\[very satisfied\\] scores; Rasch transformed score 0-100; higher scores meant better outcome).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT. Here, "number analyzed" signifies those subjects who were evaluable at the specified timepoints.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in FACE-Q Satisfaction With Lower Face and Jawline Score (Rasch-transformed) at Day 90 and Day 180, as Assessed by Subject', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 1: Octave-Ultherapy Treatment', 'description': 'Subjects received a single Octave-Ultherapy treatment of the brow, face, and neck on Day 1 of Stage 1 with two transducers.'}, {'id': 'OG001', 'title': 'Stage 2: Octave-Ultherapy Treatment', 'description': 'Subjects received a single Octave-Ultherapy treatment of the brow, face, and neck on Day 1 of Stage 2 with up to four transducers.'}], 'classes': [{'title': 'Day 90', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '25.0', 'spread': '27.22', 'groupId': 'OG000'}, {'value': '28.9', 'spread': '27.35', 'groupId': 'OG001'}]}]}, {'title': 'Day 180', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '37.2', 'spread': '17.58', 'groupId': 'OG000'}, {'value': '26.9', 'spread': '28.66', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At Baseline, Day 90 and Day 180', 'description': 'The FACE-Q is a set of standardized patient-reported outcome scales for subjects undergoing facial cosmetic procedures. The subject assessed satisfaction using the Face-Q Satisfaction with Lower Face and Jawline module (1 \\[very dissatisfied\\] to 4 \\[very satisfied\\] scores; Rasch transformed score 0-100; higher scores meant better outcome).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT. Here, "number analyzed" signifies those subjects who were evaluable at the specified timepoints.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in FACE-Q Patient-Perceived Age Visual Analogue Scale (VAS) Rating at Day 90 and Day 180, as Assessed by the Subject', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 1: Octave-Ultherapy Treatment', 'description': 'Subjects received a single Octave-Ultherapy treatment of the brow, face, and neck on Day 1 of Stage 1 with two transducers.'}, {'id': 'OG001', 'title': 'Stage 2: Octave-Ultherapy Treatment', 'description': 'Subjects received a single Octave-Ultherapy treatment of the brow, face, and neck on Day 1 of Stage 2 with up to four transducers.'}], 'classes': [{'title': 'Day 90', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.9', 'spread': '3.00', 'groupId': 'OG000'}, {'value': '-2.2', 'spread': '3.55', 'groupId': 'OG001'}]}]}, {'title': 'Day 180', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.0', 'spread': '3.16', 'groupId': 'OG000'}, {'value': '-2.4', 'spread': '4.20', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At Baseline, Day 90 and Day 180', 'description': 'For the FACE-Q Patient-perceived Age VAS, subjects were asked a question "How many years younger or older do you think you look compared with your actual age?". Perception of age compared to actual age, in years ranging from -15 years (best outcome) to +15 years (worst outcome).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT. Here, "number analyzed" signifies those subjects who were evaluable at the specified timepoints.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Treatment Emergent Adverse Events (TEAEs) Related to Octave-Ultherapy Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 1: Octave-Ultherapy Treatment', 'description': 'Subjects received a single Octave-Ultherapy treatment of the brow, face, and neck on Day 1 of Stage 1 with two transducers.'}, {'id': 'OG001', 'title': 'Stage 2: Octave-Ultherapy Treatment', 'description': 'Subjects received a single Octave-Ultherapy treatment of the brow, face, and neck on Day 1 of Stage 2 with up to four transducers.'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first treatment on Day 1 up to the end of study on Day 180 (an average of 6 months)', 'description': 'TEAEs were defined as adverse events (AEs) with onset or worsening on or after date of first administration of Octave-Ultherapy Treatment.', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'SP.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Stage 1: Octave-Ultherapy Treatment', 'description': 'Subjects received a single Octave-Ultherapy treatment of the brow, face, and neck on Day 1 of Stage 1 with two transducers.'}, {'id': 'FG001', 'title': 'Stage 2: Octave-Ultherapy Treatment', 'description': 'Subjects received a single Octave-Ultherapy treatment of the brow, face, and neck on Day 1 of Stage 2 with up to four transducers.'}], 'periods': [{'title': 'Period 1 (Day 90)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '40'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '40'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Period 2 (Day 180)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '40'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '39'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Not reconsented for Period 2', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Subjects were recruited from 3 investigational sites in the United States.', 'preAssignmentDetails': 'Of the 65 screened subjects, 15 subjects exited as screen failures and 50 subjects (10 subjects in Stage 1 and 40 subjects in Stage 2) were enrolled to receive a single Octave-Ultherapy treatment of the brow, face, and neck in this study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Stage 1: Octave-Ultherapy Treatment', 'description': 'Subjects received a single Octave-Ultherapy treatment of the brow, face, and neck on Day 1 of Stage 1 with two transducers.'}, {'id': 'BG001', 'title': 'Stage 2: Octave-Ultherapy Treatment', 'description': 'Subjects received a single Octave-Ultherapy treatment of the brow, face, and neck on Day 1 of Stage 2 with up to four transducers.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '48.3', 'spread': '9.65', 'groupId': 'BG000'}, {'value': '51.0', 'spread': '8.42', 'groupId': 'BG001'}, {'value': '50.5', 'spread': '8.64', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, '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': '1', 'groupId': 'BG001'}, {'value': '1', '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': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The safety population (SP) included all subjects who were enrolled and treated with the Octave System.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-11-16', 'size': 961217, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-09-19T10:34', 'hasProtocol': True}, {'date': '2022-09-27', 'size': 831154, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-09-19T10:10', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'While there was only one arm, Outcome Assessors were masked to pre- vs post-treatment images.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'All enrolled subjects will receive a single Octave-Ultherapy treatment of the brow, face, and neck.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-05-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'dispFirstSubmitDate': '2023-08-16', 'completionDateStruct': {'date': '2022-11-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-26', 'studyFirstSubmitDate': '2021-09-22', 'resultsFirstSubmitDate': '2025-08-15', 'studyFirstSubmitQcDate': '2021-10-04', 'dispFirstPostDateStruct': {'date': '2025-10-15', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2025-10-15', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-09-26', 'studyFirstPostDateStruct': {'date': '2021-10-05', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-10-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-08-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Treated Subjects With Eyebrow Lift at Day 90', 'timeFrame': 'Day 90', 'description': 'Improvement in eyebrow lift was determined by three evaluators after comparing Day 90 photographs with baseline photographs. Lift was concluded if at least two evaluators reported "eyebrow lift" in the Day 90 photographs as compared to baseline.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Treated Subjects With Eyebrow Lift at Day 180', 'timeFrame': 'Day 180', 'description': 'Improvement in eyebrow lift was determined by three evaluators after comparing Day 180 photographs with baseline photographs. Lift was concluded if at least two evaluators reported "eyebrow lift" in the Day 180 photographs as compared to baseline.'}, {'measure': 'Percentage of Treated Subjects With Eyebrow Lift of at Least 0.5 Millimeter (mm) at Day 90 and Day 180', 'timeFrame': 'Day 90 and Day 180', 'description': "Eyebrow lift position on frontal view was measured by calculating the differences in eyebrow height. Standard images of the subject's face were collected before treatment, and at Day 90 and Day 180 to visualize and quantify changes in the treated regions."}, {'measure': 'Change From Baseline in FACE-Q Satisfaction With Forehead and Eyebrows Score (Rasch-transformed) at Day 90 and Day 180, as Assessed by Subject', 'timeFrame': 'At Baseline, Day 90 and Day 180', 'description': 'The FACE-Q is a set of standardized patient-reported outcome scales for subjects undergoing facial cosmetic procedures. The subject assessed satisfaction using the Face-Q Satisfaction with Forehead and Eyebrows module (1 \\[very dissatisfied\\] to 4 \\[very satisfied\\] scores; Rasch transformed score 0-100; higher scores meant better outcome).'}, {'measure': 'Change From Baseline in FACE-Q Satisfaction With Lower Face and Jawline Score (Rasch-transformed) at Day 90 and Day 180, as Assessed by Subject', 'timeFrame': 'At Baseline, Day 90 and Day 180', 'description': 'The FACE-Q is a set of standardized patient-reported outcome scales for subjects undergoing facial cosmetic procedures. The subject assessed satisfaction using the Face-Q Satisfaction with Lower Face and Jawline module (1 \\[very dissatisfied\\] to 4 \\[very satisfied\\] scores; Rasch transformed score 0-100; higher scores meant better outcome).'}, {'measure': 'Change From Baseline in FACE-Q Patient-Perceived Age Visual Analogue Scale (VAS) Rating at Day 90 and Day 180, as Assessed by the Subject', 'timeFrame': 'At Baseline, Day 90 and Day 180', 'description': 'For the FACE-Q Patient-perceived Age VAS, subjects were asked a question "How many years younger or older do you think you look compared with your actual age?". Perception of age compared to actual age, in years ranging from -15 years (best outcome) to +15 years (worst outcome).'}, {'measure': 'Number of Subjects With Treatment Emergent Adverse Events (TEAEs) Related to Octave-Ultherapy Treatment', 'timeFrame': 'From first treatment on Day 1 up to the end of study on Day 180 (an average of 6 months)', 'description': 'TEAEs were defined as adverse events (AEs) with onset or worsening on or after date of first administration of Octave-Ultherapy Treatment.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Eyebrow Lift', 'Improved Appearance of the Face and Neck']}, 'descriptionModule': {'briefSummary': 'This study was conducted to evaluate the effectiveness and safety of the Octave System to lift the eyebrow and improve the appearance of the face and neck.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '35 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Mild to moderate eyebrow/upper-face laxity.\n* Mild to moderate fine lines, wrinkles, and laxity of the face and neck.\n\nExclusion Criteria:\n\n* Presence of an active systemic or local skin disease that may affect wound healing.\n* Scarring in area(s) to be treated.\n* Active implants (e.g., pacemakers or defibrillators), ports, or metallic implants in area(s) to be treated.'}, 'identificationModule': {'nctId': 'NCT05067504', 'acronym': 'LIFT-E', 'briefTitle': 'Effectiveness and Safety of the Octave System for Lifting the Eyebrow and Improving the Appearance of the Face and Neck', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merz North America, Inc.'}, 'officialTitle': 'Prospective, Evaluator-blind, Multicenter Study to Assess the Safety and Effectiveness of Treatment With the Octave System for Lifting the Eyebrow and Improving the Appearance of the Face and Neck', 'orgStudyIdInfo': {'id': 'M960101001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Octave-Ultherapy treatment', 'description': 'Octave-Ultherapy treatment of the brow, face, and neck.', 'interventionNames': ['Device: Octave-Ultherapy treatment']}], 'interventions': [{'name': 'Octave-Ultherapy treatment', 'type': 'DEVICE', 'description': 'Micro-focussed ultrasound delivered below the surface of the skin.', 'armGroupLabels': ['Octave-Ultherapy treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92083', 'city': 'Vista', 'state': 'California', 'country': 'United States', 'facility': 'Merz Investigational Site #0010358', 'geoPoint': {'lat': 33.20004, 'lon': -117.24254}}, {'zip': '33146', 'city': 'Coral Gables', 'state': 'Florida', 'country': 'United States', 'facility': 'Merz Investigational Site #0010101', 'geoPoint': {'lat': 25.72149, 'lon': -80.26838}}, {'zip': '00917', 'city': 'San Juan', 'country': 'Puerto Rico', 'facility': 'Merz Investigational Site #0010436', 'geoPoint': {'lat': 18.46633, 'lon': -66.10572}}], 'overallOfficials': [{'name': 'Merz Medical Expert', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merz North America, Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merz North America, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}