Eyebrow Lift, Improved Appearance of the Face and Neck
Conditions
Brief summary
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.
Interventions
Micro-focussed ultrasound delivered below the surface of the skin.
Sponsors
Merz North America, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
While there was only one arm, Outcome Assessors were masked to pre- vs post-treatment images.
Intervention model description
All enrolled subjects will receive a single Octave-Ultherapy treatment of the brow, face, and neck.
Eligibility
Sex/Gender
ALL
Age
35 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Mild to moderate eyebrow/upper-face laxity. * Mild to moderate fine lines, wrinkles, and laxity of the face and neck.
Exclusion criteria
* Presence of an active systemic or local skin disease that may affect wound healing. * Scarring in area(s) to be treated. * Active implants (e.g., pacemakers or defibrillators), ports, or metallic implants in area(s) to be treated.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Treated Subjects With Eyebrow Lift at Day 90 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Treated Subjects With Eyebrow Lift of at Least 0.5 Millimeter (mm) at Day 90 and Day 180 | 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. |
| Change From Baseline in FACE-Q Satisfaction With Forehead and Eyebrows Score (Rasch-transformed) at Day 90 and Day 180, as Assessed by Subject | At Baseline, Day 90 and Day 180 | 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). |
| Percentage of Treated Subjects With Eyebrow Lift at Day 180 | 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. |
| 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 | At Baseline, Day 90 and Day 180 | 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). |
| Number of Subjects With Treatment Emergent Adverse Events (TEAEs) Related to Octave-Ultherapy Treatment | From first treatment on Day 1 up to the end of study on Day 180 (an average of 6 months) | TEAEs were defined as adverse events (AEs) with onset or worsening on or after date of first administration of Octave-Ultherapy Treatment. |
| 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 | At Baseline, Day 90 and Day 180 | 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). |
Countries
Puerto Rico, United States
Participant flow
Recruitment details
Subjects were recruited from 3 investigational sites in the United States.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 10 |
| 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. | 40 |
| Total | 50 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Period 2 (Day 180) | Lost to Follow-up | 0 | 1 |
| Period 2 (Day 180) | Not reconsented for Period 2 | 3 | 0 |
| Period 2 (Day 180) | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Stage 2: Octave-Ultherapy Treatment | Total | Stage 1: Octave-Ultherapy Treatment |
|---|---|---|---|
| Age, Continuous | 51.0 years STANDARD_DEVIATION 8.42 | 50.5 years STANDARD_DEVIATION 8.64 | 48.3 years STANDARD_DEVIATION 9.65 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 25 Participants | 28 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 15 Participants | 22 Participants | 7 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 5 Participants | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 35 Participants | 41 Participants | 6 Participants |
| Sex: Female, Male Female | 36 Participants | 44 Participants | 8 Participants |
| Sex: Female, Male Male | 4 Participants | 6 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 40 |
| other Total, other adverse events | 5 / 10 | 5 / 40 |
| serious Total, serious adverse events | 0 / 10 | 1 / 40 |
Outcome results
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.
Time frame: Day 90
Population: Intent-to-treat (ITT) population included all subjects who were enrolled.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Stage 1: Octave-Ultherapy Treatment | Percentage of Treated Subjects With Eyebrow Lift at Day 90 | 80.0 percentage of subjects |
| Stage 2: Octave-Ultherapy Treatment | Percentage of Treated Subjects With Eyebrow Lift at Day 90 | 67.5 percentage of subjects |
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).
Time frame: At Baseline, Day 90 and Day 180
Population: ITT. Here, number analyzed signifies those subjects who were evaluable at the specified timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stage 1: Octave-Ultherapy Treatment | 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 | Day 90 | -0.9 score on a scale | Standard Deviation 3 |
| Stage 1: Octave-Ultherapy Treatment | 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 | Day 180 | -2.0 score on a scale | Standard Deviation 3.16 |
| Stage 2: Octave-Ultherapy Treatment | 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 | Day 90 | -2.2 score on a scale | Standard Deviation 3.55 |
| Stage 2: Octave-Ultherapy Treatment | 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 | Day 180 | -2.4 score on a scale | Standard Deviation 4.2 |
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).
Time frame: At Baseline, Day 90 and Day 180
Population: ITT. Here, number analyzed signifies those subjects who were evaluable at the specified timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stage 1: Octave-Ultherapy Treatment | Change From Baseline in FACE-Q Satisfaction With Forehead and Eyebrows Score (Rasch-transformed) at Day 90 and Day 180, as Assessed by Subject | Day 90 | 10.1 score on a scale | Standard Deviation 33.27 |
| Stage 1: Octave-Ultherapy Treatment | Change From Baseline in FACE-Q Satisfaction With Forehead and Eyebrows Score (Rasch-transformed) at Day 90 and Day 180, as Assessed by Subject | Day 180 | 20.5 score on a scale | Standard Deviation 11.48 |
| Stage 2: Octave-Ultherapy Treatment | Change From Baseline in FACE-Q Satisfaction With Forehead and Eyebrows Score (Rasch-transformed) at Day 90 and Day 180, as Assessed by Subject | Day 90 | 21.1 score on a scale | Standard Deviation 22.12 |
| Stage 2: Octave-Ultherapy Treatment | Change From Baseline in FACE-Q Satisfaction With Forehead and Eyebrows Score (Rasch-transformed) at Day 90 and Day 180, as Assessed by Subject | Day 180 | 22.7 score on a scale | Standard Deviation 20.51 |
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).
Time frame: At Baseline, Day 90 and Day 180
Population: ITT. Here, number analyzed signifies those subjects who were evaluable at the specified timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stage 1: Octave-Ultherapy Treatment | 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 | Day 90 | 25.0 score on a scale | Standard Deviation 27.22 |
| Stage 1: Octave-Ultherapy Treatment | 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 | Day 180 | 37.2 score on a scale | Standard Deviation 17.58 |
| Stage 2: Octave-Ultherapy Treatment | 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 | Day 90 | 28.9 score on a scale | Standard Deviation 27.35 |
| Stage 2: Octave-Ultherapy Treatment | 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 | Day 180 | 26.9 score on a scale | Standard Deviation 28.66 |
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.
Time frame: From first treatment on Day 1 up to the end of study on Day 180 (an average of 6 months)
Population: SP.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Stage 1: Octave-Ultherapy Treatment | Number of Subjects With Treatment Emergent Adverse Events (TEAEs) Related to Octave-Ultherapy Treatment | 4 Participants |
| Stage 2: Octave-Ultherapy Treatment | Number of Subjects With Treatment Emergent Adverse Events (TEAEs) Related to Octave-Ultherapy Treatment | 6 Participants |
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.
Time frame: Day 180
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Stage 1: Octave-Ultherapy Treatment | Percentage of Treated Subjects With Eyebrow Lift at Day 180 | 81.7 percentage of subjects |
| Stage 2: Octave-Ultherapy Treatment | Percentage of Treated Subjects With Eyebrow Lift at Day 180 | 64.7 percentage of subjects |
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.
Time frame: Day 90 and Day 180
Population: ITT.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Stage 1: Octave-Ultherapy Treatment | Percentage of Treated Subjects With Eyebrow Lift of at Least 0.5 Millimeter (mm) at Day 90 and Day 180 | Day 90 | 20.0 percentage of subjects |
| Stage 1: Octave-Ultherapy Treatment | Percentage of Treated Subjects With Eyebrow Lift of at Least 0.5 Millimeter (mm) at Day 90 and Day 180 | Day 180 | 16.7 percentage of subjects |
| Stage 2: Octave-Ultherapy Treatment | Percentage of Treated Subjects With Eyebrow Lift of at Least 0.5 Millimeter (mm) at Day 90 and Day 180 | Day 90 | 27.5 percentage of subjects |
| Stage 2: Octave-Ultherapy Treatment | Percentage of Treated Subjects With Eyebrow Lift of at Least 0.5 Millimeter (mm) at Day 90 and Day 180 | Day 180 | 30.8 percentage of subjects |