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

NCT05067504 | Completed Results FDA Device

• 1 other identifier: M960101001
• Study Type: interventional
• Target: 50
• Locations: 2 countries
• Sites: 3

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.

Conditions

Eyebrow Lift; Improved Appearance of the Face and Neck

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (6)

• Percentage of Treated Subjects With Eyebrow Lift at Day 180

  Day 180

• 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

• 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

• 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

• 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

Study Arms (1)

Octave-Ultherapy treatment

EXPERIMENTAL

Octave-Ultherapy treatment of the brow, face, and neck.

Device: Octave-Ultherapy treatment

Interventions

Octave-Ultherapy treatment DEVICE

Micro-focussed ultrasound delivered below the surface of the skin.

Octave-Ultherapy treatment

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Mild to moderate eyebrow/upper-face laxity.
• Mild to moderate fine lines, wrinkles, and laxity of the face and neck.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Merz North America, Inc.: lead

Study Sites (3)

Merz Investigational Site #0010358

Vista, California, 92083, United States

Location

Merz Investigational Site #0010101

Coral Gables, Florida, 33146, United States

Location

Merz Investigational Site #0010436

San Juan, 00917, Puerto Rico

Location

Results Point of Contact

• Title: Public Disclosure Manager
• Organization: Merz Aesthetics

Aesthetic.Trials@merz.com

+1 984-301-3095

Study Officials

• Merz Medical Expert

  Merz North America, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: While there was only one arm, Outcome Assessors were masked to pre- vs post-treatment images.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: All enrolled subjects will receive a single Octave-Ultherapy treatment of the brow, face, and neck.

Study Record Dates

• First Submitted: September 22, 2021
• First Posted: October 5, 2021
• Study Start: May 24, 2021
• Primary Completion: August 17, 2022
• Study Completion: November 14, 2022
• Last Updated: October 15, 2025
• Results First Posted: October 15, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (2); PR (1)