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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Octave-Ultherapy treatment | Experimental | Octave-Ultherapy treatment of the brow, face, and neck. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Octave-Ultherapy treatment | Device | Micro-focussed ultrasound delivered below the surface of the skin. |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Treated Subjects With Eyebrow Lift at Day 90 | 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. | Day 90 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Treated Subjects With Eyebrow Lift at Day 180 | 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. | Day 180 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Merz Medical Expert | Merz North America, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Merz Investigational Site #0010358 | Vista | California | 92083 | United States | ||
| Merz Investigational Site #0010101 |
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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.
Subjects were recruited from 3 investigational sites in the United States.
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| ID | Title | Description |
|---|---|---|
| FG000 | Stage 1: Octave-Ultherapy Treatment | Subjects received a single Octave-Ultherapy treatment of the brow, face, and neck on Day 1 of Stage 1 with two transducers. |
| FG001 | Stage 2: Octave-Ultherapy Treatment |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Period 1 (Day 90) |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 16, 2021 | Sep 19, 2023 |
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All enrolled subjects will receive a single Octave-Ultherapy treatment of the brow, face, and neck.
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While there was only one arm, Outcome Assessors were masked to pre- vs post-treatment images.
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| Percentage of Treated Subjects With Eyebrow Lift of at Least 0.5 Millimeter (mm) at Day 90 and Day 180 |
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. |
| Day 90 and Day 180 |
| Change From Baseline in FACE-Q Satisfaction With Forehead and Eyebrows Score (Rasch-transformed) at Day 90 and Day 180, as Assessed by Subject | 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). | At Baseline, Day 90 and Day 180 |
| 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 | 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). | At Baseline, Day 90 and Day 180 |
| 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 | 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). | At Baseline, Day 90 and Day 180 |
| Number of Subjects With Treatment Emergent Adverse Events (TEAEs) Related to Octave-Ultherapy Treatment | TEAEs were defined as adverse events (AEs) with onset or worsening on or after date of first administration of Octave-Ultherapy Treatment. | From first treatment on Day 1 up to the end of study on Day 180 (an average of 6 months) |
| Coral Gables |
| Florida |
| 33146 |
| United States |
| Merz Investigational Site #0010436 | San Juan | 00917 | Puerto Rico |
Subjects received a single Octave-Ultherapy treatment of the brow, face, and neck on Day 1 of Stage 2 with up to four transducers.
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| NOT COMPLETED |
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| Period 2 (Day 180) |
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The safety population (SP) included all subjects who were enrolled and treated with the Octave System.
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| ID | Title | Description |
|---|---|---|
| BG000 | Stage 1: Octave-Ultherapy Treatment | Subjects received a single Octave-Ultherapy treatment of the brow, face, and neck on Day 1 of Stage 1 with two transducers. |
| BG001 | Stage 2: Octave-Ultherapy Treatment | Subjects received a single Octave-Ultherapy treatment of the brow, face, and neck on Day 1 of Stage 2 with up to four transducers. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants | No |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
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| Race (NIH/OMB) | Count of Participants | Participants | No |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Treated Subjects With Eyebrow Lift at Day 90 | 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. | Intent-to-treat (ITT) population included all subjects who were enrolled. | Posted | Number | percentage of subjects | Day 90 |
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| Secondary | Percentage of Treated Subjects With Eyebrow Lift at Day 180 | 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. | 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. | Posted | Number | percentage of subjects | Day 180 |
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| Secondary | Percentage of Treated Subjects With Eyebrow Lift of at Least 0.5 Millimeter (mm) at Day 90 and Day 180 | 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. | ITT. | Posted | Number | percentage of subjects | Day 90 and Day 180 |
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| Secondary | Change From Baseline in FACE-Q Satisfaction With Forehead and Eyebrows Score (Rasch-transformed) at Day 90 and Day 180, as Assessed by Subject | 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). | ITT. Here, "number analyzed" signifies those subjects who were evaluable at the specified timepoints. | Posted | Mean | Standard Deviation | score on a scale | At Baseline, Day 90 and Day 180 |
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| Secondary | 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 | 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). | ITT. Here, "number analyzed" signifies those subjects who were evaluable at the specified timepoints. | Posted | Mean | Standard Deviation | score on a scale | At Baseline, Day 90 and Day 180 |
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| Secondary | 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 | 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). | ITT. Here, "number analyzed" signifies those subjects who were evaluable at the specified timepoints. | Posted | Mean | Standard Deviation | score on a scale | At Baseline, Day 90 and Day 180 |
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| Secondary | Number of Subjects With Treatment Emergent Adverse Events (TEAEs) Related to Octave-Ultherapy Treatment | TEAEs were defined as adverse events (AEs) with onset or worsening on or after date of first administration of Octave-Ultherapy Treatment. | SP. | Posted | Count of Participants | Participants | No | From first treatment on Day 1 up to the end of study on Day 180 (an average of 6 months) |
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From first treatment on Day 1 up to the end of study on Day 180 (an average of 6 months)
SP. The investigator reported AEs systematically at each visit.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Stage 1: Octave-Ultherapy Treatment | Subjects received a single Octave-Ultherapy treatment of the brow, face, and neck on Day 1 of Stage 1 with two transducers. | 0 | 10 | 0 | 10 | 5 | 10 |
| EG001 | Stage 2: Octave-Ultherapy Treatment | Subjects received a single Octave-Ultherapy treatment of the brow, face, and neck on Day 1 of Stage 2 with up to four transducers. | 0 | 40 | 1 | 40 | 5 | 40 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Follicular lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.1 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Application site pain | General disorders | MedDRA 25.1 | Systematic Assessment |
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| Application site pruritus | General disorders | MedDRA 25.1 | Systematic Assessment |
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| Application site urticaria | General disorders | MedDRA 25.1 | Systematic Assessment |
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| Application site discomfort | General disorders | MedDRA 25.1 | Systematic Assessment |
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| Application site dysaesthesia | General disorders | MedDRA 25.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
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| Diverticulitis | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Public Disclosure Manager | Merz Aesthetics | +1 984-301-3095 | Aesthetic.Trials@merz.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 27, 2022 | Sep 19, 2023 | SAP_001.pdf |
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| Not reconsented for Period 2 |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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