Effectiveness and Safety of the Octave System for Lifting the Eyebrow and Improving the Appearance of the Face and Neck (LIFT-E)

Prospective, Evaluator-blind, Multicenter Study to Assess the Safety and Effectiveness of Treatment With the Octave System for Lifting the Eyebrow and Improving the Appearance of the Face and Neck

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.

Study Overview

• Status: Completed
• Conditions: Eyebrow Lift; Improved Appearance of the Face and Neck
• Intervention / Treatment: Device: Octave-Ultherapy treatment

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Puerto Rico
  • San Juan, Puerto Rico, 00917
    • Merz Investigational Site #0010436
• United States
  • California
    • Vista, California, United States, 92083
      • Merz Investigational Site #0010358
  • Florida
    • Coral Gables, Florida, United States, 33146
      • Merz Investigational Site #0010101

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Octave-Ultherapy treatment; Octave-Ultherapy treatment of the brow, face, and neck.	Device: Octave-Ultherapy treatment; Micro-focussed ultrasound delivered below the surface of the skin.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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).	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).	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	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).	At Baseline, Day 90 and Day 180
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.	From first treatment on Day 1 up to the end of study on Day 180 (an average of 6 months)

Collaborators and Investigators

• Sponsor: Merz North America, Inc.
• Investigators: Study Director: Merz Medical Expert, Merz North America, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): May 24, 2021
• Primary Completion (Actual): August 17, 2022
• Study Completion (Actual): November 14, 2022

Study Registration Dates

• First Submitted: September 22, 2021
• First Submitted That Met QC Criteria: October 4, 2021
• First Posted (Actual): October 5, 2021

Study Record Updates

• Last Update Posted (Estimated): October 15, 2025
• Last Update Submitted That Met QC Criteria: September 26, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: M960101001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes