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

Study Overview
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Brief Summary
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To demonstrate the safety and effectiveness of the Octave System for improving lines and wrinkles of the décolleté.

Official Title
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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

Conditions
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Décolleté Wrinkles

Intervention / Treatment
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* Device: Octave-Ultherapy treatment


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Octave System<br>Single treatment of décolleté tissue. | Device: Octave-Ultherapy treatment<br>* Micro-focused ultrasound delivered below the surface of the skin.<br>|

What is the study measuring?
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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) |