A Study of Octave System for Improving Lines and Wrinkles of the Décolleté

Prospective, Evaluator-blind, Multicenter Study to Assess the Safety and Effectiveness of Treatment With the Octave System for Improving Lines and Wrinkles of the décolleté

To demonstrate the safety and effectiveness of the Octave System for improving lines and wrinkles of the décolleté.

Study Overview

• Status: Completed
• Conditions: Décolleté Wrinkles
• Intervention / Treatment: Device: Octave-Ultherapy treatment

• Study Type: Interventional
• Enrollment (Actual): 99
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Beverly Hills, California, United States, 90210
      • Merz Investigational Site #0010395
    • San Mateo, California, United States, 92121
      • Merz Investigational Site #0010321
  • Connecticut
    • Norwalk, Connecticut, United States, 06851
      • Merz Investigational Site #0010352
  • Florida
    • Miami, Florida, United States, 33137
      • Merz Investigational Site #0010416
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Merz Investigational Site #0010346
  • New York
    • New York, New York, United States, 10022
      • Merz Investigational Site #0010439
    • New York, New York, United States, 10075
      • Merz Investigational Site #0010452
  • North Carolina
    • Wilmington, North Carolina, United States, 28403
      • Merz Investigational Site #0010396
  • Texas
    • Plano, Texas, United States, 75093
      • Merz Investigational Site #0010125
  • Washington
    • Spokane, Washington, United States, 99202
      • Merz Investigational Site #0010392

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

- Moderate to severe fine lines, wrinkles, laxity, and crepiness of the décolleté that is amenable to improvement with non-invasive intervention and is not severe enough for surgical intervention.

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.
• Breast implants or is planning to receive breast implants during the study.
• Inability to take pre-treatment medications due to a pre-existing condition, medication allergy, or medical issue that, at the discretion of the treating investigator, is contraindicated.

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 System; Single treatment of décolleté tissue.	Device: Octave-Ultherapy treatment; Micro-focused 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 Improvement in Lines and Wrinkles of the Décolleté at Day 90	Improvement in lines and wrinkles of the décolleté were determined after comparing Day 90 photographs with baseline photographs. Improvement was concluded if at least two evaluators assessed the Day 90 photographs as "improved" compared to baseline.	Day 90

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Treated Subjects With Improvement in Lines and Wrinkles of the Décolleté at Day 180	Improvement in lines and wrinkles of the décolleté were determined after comparing Day 180 photographs with baseline photographs. Improvement was concluded if at least two evaluators assessed the Day 180 photographs as "improved" compared to baseline.	Day 180
Number of Subjects With Treatment-emergent Adverse Events (TEAEs)	TEAEs were defined as adverse events (AEs) with onset or worsening on or after date of first administration of Octave-Ultherapy Treatment.	From Day 1 up to end of the study (Up to Day 180)

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): December 29, 2020
• Primary Completion (Actual): November 24, 2021
• Study Completion (Actual): February 21, 2022

Study Registration Dates

• First Submitted: December 18, 2020
• First Submitted That Met QC Criteria: December 18, 2020
• First Posted (Actual): December 23, 2020

Study Record Updates

• Last Update Posted (Estimated): January 18, 2024
• Last Update Submitted That Met QC Criteria: December 21, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: M960101003

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