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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

99 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-29

Study Completion Date

2022-02-21

Brief Summary

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

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Detailed Description

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Conditions

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Décolleté Wrinkles

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

While there was only one arm, Outcome Assessors were masked to pre- vs post-treatment images.

Study Groups

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Octave System

Single treatment of décolleté tissue.

Group Type EXPERIMENTAL

Octave-Ultherapy treatment

Intervention Type DEVICE

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

Interventions

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Octave-Ultherapy treatment

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

Intervention Type DEVICE

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.

Minimum Eligible Age

35 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No