Effectiveness and Safety of the Octave System for Lifting the Eyebrow and Improving the Appearance of the Face and Neck

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

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

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

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).