Trial Outcomes & Findings for Effectiveness and Safety of the Octave System for Lifting the Eyebrow and Improving the Appearance of the Face and Neck (NCT NCT05067504)
NCT ID: NCT05067504
Last Updated: 2025-10-15
Results Overview
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.
COMPLETED
NA
50 participants
Day 90
2025-10-15
Participant Flow
Subjects were recruited from 3 investigational sites in the United States.
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.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Period 1 (Day 90)
STARTED
|
10
|
40
|
|
Period 1 (Day 90)
COMPLETED
|
10
|
40
|
|
Period 1 (Day 90)
NOT COMPLETED
|
0
|
0
|
|
Period 2 (Day 180)
STARTED
|
10
|
40
|
|
Period 2 (Day 180)
COMPLETED
|
6
|
39
|
|
Period 2 (Day 180)
NOT COMPLETED
|
4
|
1
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Period 2 (Day 180)
Lost to Follow-up
|
0
|
1
|
|
Period 2 (Day 180)
Withdrawal by Subject
|
1
|
0
|
|
Period 2 (Day 180)
Not reconsented for Period 2
|
3
|
0
|
Baseline Characteristics
Effectiveness and Safety of the Octave System for Lifting the Eyebrow and Improving the Appearance of the Face and Neck
Baseline characteristics by cohort
| Measure |
Stage 1: Octave-Ultherapy Treatment
n=10 Participants
Subjects received a single Octave-Ultherapy treatment of the brow, face, and neck on Day 1 of Stage 1 with two transducers.
|
Stage 2: Octave-Ultherapy Treatment
n=40 Participants
Subjects received a single Octave-Ultherapy treatment of the brow, face, and neck on Day 1 of Stage 2 with up to four transducers.
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
48.3 years
STANDARD_DEVIATION 9.65 • n=5 Participants
|
51.0 years
STANDARD_DEVIATION 8.42 • n=7 Participants
|
50.5 years
STANDARD_DEVIATION 8.64 • n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 90Population: Intent-to-treat (ITT) population included all subjects who were enrolled.
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.
Outcome measures
| Measure |
Stage 1: Octave-Ultherapy Treatment
n=10 Participants
Subjects received a single Octave-Ultherapy treatment of the brow, face, and neck on Day 1 of Stage 1 with two transducers.
|
Stage 2: Octave-Ultherapy Treatment"
n=40 Participants
Subjects received a single Octave-Ultherapy treatment of the brow, face, and neck on Day 1 of Stage 2 with up to four transducers.
|
|---|---|---|
|
Percentage of Treated Subjects With Eyebrow Lift at Day 90
|
80.0 percentage of subjects
|
67.5 percentage of subjects
|
SECONDARY outcome
Timeframe: Day 180Population: 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.
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.
Outcome measures
| Measure |
Stage 1: Octave-Ultherapy Treatment
n=7 Participants
Subjects received a single Octave-Ultherapy treatment of the brow, face, and neck on Day 1 of Stage 1 with two transducers.
|
Stage 2: Octave-Ultherapy Treatment"
n=40 Participants
Subjects received a single Octave-Ultherapy treatment of the brow, face, and neck on Day 1 of Stage 2 with up to four transducers.
|
|---|---|---|
|
Percentage of Treated Subjects With Eyebrow Lift at Day 180
|
81.7 percentage of subjects
|
64.7 percentage of subjects
|
SECONDARY outcome
Timeframe: Day 90 and Day 180Population: ITT.
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.
Outcome measures
| Measure |
Stage 1: Octave-Ultherapy Treatment
n=10 Participants
Subjects received a single Octave-Ultherapy treatment of the brow, face, and neck on Day 1 of Stage 1 with two transducers.
|
Stage 2: Octave-Ultherapy Treatment"
n=40 Participants
Subjects received a single Octave-Ultherapy treatment of the brow, face, and neck on Day 1 of Stage 2 with up to four transducers.
|
|---|---|---|
|
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
|
27.5 percentage of subjects
|
|
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
|
30.8 percentage of subjects
|
SECONDARY outcome
Timeframe: At Baseline, Day 90 and Day 180Population: ITT. Here, "number analyzed" signifies those subjects who were evaluable at the specified timepoints.
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).
Outcome measures
| Measure |
Stage 1: Octave-Ultherapy Treatment
n=10 Participants
Subjects received a single Octave-Ultherapy treatment of the brow, face, and neck on Day 1 of Stage 1 with two transducers.
|
Stage 2: Octave-Ultherapy Treatment"
n=40 Participants
Subjects received a single Octave-Ultherapy treatment of the brow, face, and neck on Day 1 of Stage 2 with up to four transducers.
|
|---|---|---|
|
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
|
21.1 score on a scale
Standard Deviation 22.12
|
|
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
|
22.7 score on a scale
Standard Deviation 20.51
|
SECONDARY outcome
Timeframe: At Baseline, Day 90 and Day 180Population: ITT. Here, "number analyzed" signifies those subjects who were evaluable at the specified timepoints.
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).
Outcome measures
| Measure |
Stage 1: Octave-Ultherapy Treatment
n=10 Participants
Subjects received a single Octave-Ultherapy treatment of the brow, face, and neck on Day 1 of Stage 1 with two transducers.
|
Stage 2: Octave-Ultherapy Treatment"
n=40 Participants
Subjects received a single Octave-Ultherapy treatment of the brow, face, and neck on Day 1 of Stage 2 with up to four transducers.
|
|---|---|---|
|
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
|
28.9 score on a scale
Standard Deviation 27.35
|
|
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
|
26.9 score on a scale
Standard Deviation 28.66
|
SECONDARY outcome
Timeframe: At Baseline, Day 90 and Day 180Population: ITT. Here, "number analyzed" signifies those subjects who were evaluable at the specified timepoints.
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).
Outcome measures
| Measure |
Stage 1: Octave-Ultherapy Treatment
n=10 Participants
Subjects received a single Octave-Ultherapy treatment of the brow, face, and neck on Day 1 of Stage 1 with two transducers.
|
Stage 2: Octave-Ultherapy Treatment"
n=40 Participants
Subjects received a single Octave-Ultherapy treatment of the brow, face, and neck on Day 1 of Stage 2 with up to four transducers.
|
|---|---|---|
|
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 3.00
|
-2.2 score on a scale
Standard Deviation 3.55
|
|
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
|
-2.4 score on a scale
Standard Deviation 4.20
|
SECONDARY outcome
Timeframe: From first treatment on Day 1 up to the end of study on Day 180 (an average of 6 months)Population: SP.
TEAEs were defined as adverse events (AEs) with onset or worsening on or after date of first administration of Octave-Ultherapy Treatment.
Outcome measures
| Measure |
Stage 1: Octave-Ultherapy Treatment
n=10 Participants
Subjects received a single Octave-Ultherapy treatment of the brow, face, and neck on Day 1 of Stage 1 with two transducers.
|
Stage 2: Octave-Ultherapy Treatment"
n=40 Participants
Subjects received a single Octave-Ultherapy treatment of the brow, face, and neck on Day 1 of Stage 2 with up to four transducers.
|
|---|---|---|
|
Number of Subjects With Treatment Emergent Adverse Events (TEAEs) Related to Octave-Ultherapy Treatment
|
4 Participants
|
6 Participants
|
Adverse Events
Stage 1: Octave-Ultherapy Treatment
Stage 2: Octave-Ultherapy Treatment
Serious adverse events
| Measure |
Stage 1: Octave-Ultherapy Treatment
n=10 participants at risk
Subjects received a single Octave-Ultherapy treatment of the brow, face, and neck on Day 1 of Stage 1 with two transducers.
|
Stage 2: Octave-Ultherapy Treatment
n=40 participants at risk
Subjects received a single Octave-Ultherapy treatment of the brow, face, and neck on Day 1 of Stage 2 with up to four transducers.
|
|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Follicular lymphoma
|
0.00%
0/10 • 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.
|
2.5%
1/40 • 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.
|
Other adverse events
| Measure |
Stage 1: Octave-Ultherapy Treatment
n=10 participants at risk
Subjects received a single Octave-Ultherapy treatment of the brow, face, and neck on Day 1 of Stage 1 with two transducers.
|
Stage 2: Octave-Ultherapy Treatment
n=40 participants at risk
Subjects received a single Octave-Ultherapy treatment of the brow, face, and neck on Day 1 of Stage 2 with up to four transducers.
|
|---|---|---|
|
General disorders
Application site pain
|
20.0%
2/10 • 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.
|
5.0%
2/40 • 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.
|
|
General disorders
Application site pruritus
|
10.0%
1/10 • 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.
|
5.0%
2/40 • 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.
|
|
General disorders
Application site urticaria
|
10.0%
1/10 • 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.
|
5.0%
2/40 • 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.
|
|
General disorders
Application site discomfort
|
10.0%
1/10 • 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.
|
0.00%
0/40 • 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.
|
|
General disorders
Application site dysaesthesia
|
10.0%
1/10 • 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.
|
0.00%
0/40 • 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.
|
|
Nervous system disorders
Headache
|
10.0%
1/10 • 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.
|
2.5%
1/40 • 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.
|
|
Infections and infestations
Diverticulitis
|
10.0%
1/10 • 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.
|
0.00%
0/40 • 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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER