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

Not Applicable

Completed

• Conditions: Décolleté Wrinkles
• Interventions: Device: Octave-Ultherapy treatment

• Registration Number: NCT04681352
• Lead Sponsor: Merz North America, Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-12-18
• Study First Submitted QC: 2020-12-18
• Study First Posted: 2020-12-23
• Study Start: 2020-12-29
• Primary Completion: 2021-11-24
• Study Completion: 2022-02-21
• Disposition First Submitted: 2022-11-23
• Disposition First Submitted QC: 2022-11-23
• Disposition First Posted: 2022-11-28
• Status Verified: 2023-12
• Results First Submitted: 2023-12-01
• Results First Submitted QC: 2023-12-01
• Results First Posted: 2023-12-21
• Last Update Submitted: 2023-12-21
• Last Update Posted: 2024-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 99

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Octave System	Octave-Ultherapy treatment	Single treatment of décolleté tissue.

Primary Outcome Measures

Name	Time	Method
Percentage of Treated Subjects With Improvement in Lines and Wrinkles of the Décolleté at Day 90	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.

Secondary Outcome Measures

Name	Time	Method
Percentage of Treated Subjects With Improvement in Lines and Wrinkles of the Décolleté at Day 180	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.
Number of Subjects With Treatment-emergent Adverse Events (TEAEs)	From Day 1 up to end of the study (Up to Day 180)	TEAEs were defined as adverse events (AEs) with onset or worsening on or after date of first administration of Octave-Ultherapy Treatment.

Trial Locations

Locations (10)

Merz Investigational Site #0010416; 🇺🇸 Miami, Florida, United States

Merz Investigational Site #0010352; 🇺🇸 Norwalk, Connecticut, United States

Merz Investigational Site #0010395; 🇺🇸 Beverly Hills, California, United States

Merz Investigational Site #0010321; 🇺🇸 San Mateo, California, United States

Merz Investigational Site #0010346; 🇺🇸 Chicago, Illinois, United States

Merz Investigational Site #0010439; 🇺🇸 New York, New York, United States

Merz Investigational Site #0010396; 🇺🇸 Wilmington, North Carolina, United States

Merz Investigational Site #0010392; 🇺🇸 Spokane, Washington, United States

Merz Investigational Site #0010452; 🇺🇸 New York, New York, United States

Merz Investigational Site #0010125; 🇺🇸 Plano, Texas, United States