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

NCT04681352 | Completed Results FDA Device

• 1 other identifier: M960101003
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 10

Brief Summary

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

Conditions

Décolleté Wrinkles

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Percentage of Treated Subjects With Improvement in Lines and Wrinkles of the Décolleté at Day 180

  Day 180

• Number of Subjects With Treatment-emergent Adverse Events (TEAEs)

  From Day 1 up to end of the study (Up to Day 180)

Study Arms (1)

Octave System

EXPERIMENTAL

Single treatment of décolleté tissue.

Device: Octave-Ultherapy treatment

Interventions

Octave-Ultherapy treatment DEVICE

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

Octave System

Eligibility Criteria

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

You may qualify if:

• \- 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.

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.
• 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.

Sponsors & Collaborators

• Merz North America, Inc.: lead
• Ulthera, Inc: collaborator

Study Sites (10)

Merz Investigational Site #0010395

Beverly Hills, California, 90210, United States

Location

Merz Investigational Site #0010321

San Mateo, California, 92121, United States

Location

Merz Investigational Site #0010352

Norwalk, Connecticut, 06851, United States

Location

Merz Investigational Site #0010416

Miami, Florida, 33137, United States

Location

Merz Investigational Site #0010346

Chicago, Illinois, 60611, United States

Location

Merz Investigational Site #0010439

New York, New York, 10022, United States

Location

Merz Investigational Site #0010452

New York, New York, 10075, United States

Location

Merz Investigational Site #0010396

Wilmington, North Carolina, 28403, United States

Location

Merz Investigational Site #0010125

Plano, Texas, 75093, United States

Location

Merz Investigational Site #0010392

Spokane, Washington, 99202, United States

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

Study Record Dates

• First Submitted: December 18, 2020
• First Posted: December 23, 2020
• Study Start: December 29, 2020
• Primary Completion: November 24, 2021
• Study Completion: February 21, 2022
• Last Updated: January 18, 2024
• Results First Posted: December 21, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (10)