Effectiveness and Safety of the Octave System for Lifting the Eyebrow and Improving the Appearance of the Face and Neck

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

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-24

Study Completion Date

2022-11-14

Brief Summary

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This study was conducted to evaluate the effectiveness and safety of the Octave System to lift the eyebrow and improve the appearance of the face and neck.

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Detailed Description

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Conditions

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Eyebrow Lift Improved Appearance of the Face and Neck

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

All enrolled subjects will receive a single Octave-Ultherapy treatment of the brow, face, and neck.

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-Ultherapy treatment

Octave-Ultherapy treatment of the brow, face, and neck.

Group Type EXPERIMENTAL

Octave-Ultherapy treatment

Intervention Type DEVICE

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

Interventions

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Octave-Ultherapy treatment

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Mild to moderate eyebrow/upper-face laxity.
* Mild to moderate fine lines, wrinkles, and laxity of the face and neck.

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.

Minimum Eligible Age

35 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No