N/A
N=50
Effectiveness and Safety of the Octave System for Lifting the Eyebrow and Improving the Appearance of the Face and Neck
Eyebrow Lift · Improved Appearance of the Face and Neck
Bottom Line
View on ClinicalTrials.gov: NCT05067504 ↗Enrolled (actual)
50
Serious AEs
2.0%
Results posted
Oct 2025
Primary outcome: Primary: Percentage of Treated Subjects With Eyebrow Lift at Day 90 — 80.0; 67.5 percentage of subjects
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Octave-Ultherapy treatment (Device)
- Age
- Adult, Older Adult · 35+ yrs
- Sex
- All
- Sponsor
- Merz North America, Inc.
- Primary completion
- Aug 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Treated Subjects With Eyebrow Lift at Day 90 |
80.0; 67.5 | — |
| SECONDARY Percentage of Treated Subjects With Eyebrow Lift at Day 180 |
81.7; 64.7 | — |
| SECONDARY Percentage of Treated Subjects With Eyebrow Lift of at Least 0.5 Millimeter (mm) at Day 90 and Day 180 |
20.0; 27.5; 16.7; 30.8 | — |
| 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 |
10.1; 21.1; 20.5; 22.7 | — |
| 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 |
25.0; 28.9; 37.2; 26.9 | — |
| 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 |
-0.9; -2.2; -2.0; -2.4 | — |
| SECONDARY Number of Subjects With Treatment Emergent Adverse Events (TEAEs) Related to Octave-Ultherapy Treatment |
4; 6 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT05067504). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.