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Completed

NCT Number: NCT04681352

A Study of 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.

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Key information

Conditions

Décolleté Wrinkles

Age range

35 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Merz Investigational Site #0010395, Beverly Hills, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Octave-Ultherapy treatment

Device

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

Primary outcomes

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

    Time frame: 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 outcomes

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

    Time frame: 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.

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Merz North America, Inc.

Industry

Collaborators

  • Ulthera, Inc

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Dec 23, 2020
Registry last updated
Jan 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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