Evaluation of the Effectiveness and Safety of the Ulthera® DeepSEE® System for Treating Skin Laxity in the Lower Face and Submentum

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

201 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-16

Study Completion Date

2022-05-17

Brief Summary

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1. Demonstrate superiority of treatment with the Ulthera DeepSEE System compared to untreated control for the improvement of skin laxity of the lower face and submental area.
2. Demonstrate the safety of treatment with the Ulthera DeepSEE System for the improvement of skin laxity of the lower face and submental area.

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Detailed Description

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Subjects in the study received a single treatment with Ulthera DeepSEE system on the midface, lower face, submental (under the chin) and upper neck area using 3 DeepSEE (DS) transducers (DS 10-1.5, DS 7-3.0, DS 7-4.5) at either Day 1 or Day 90. Subjects treated at Day 1 were followed for 180 days after treatment and subjects treated at Day 90 were followed for 90 days after treatment.

Conditions

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Improvement in Skin Laxity of the Lower Face and Submentum

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Treatment Ulthera System

Group Type EXPERIMENTAL

Ultherapy treatment

Intervention Type DEVICE

Focused ultrasound energy delivered below the surface of the skin

Delayed-treatment Ulthera System

Group Type OTHER

Untreated-control / delayed-treatment

Intervention Type DEVICE

Untreated-control, followed by Ultherapy treatment (focused ultrasound energy delivered below the surface of the skin)

Interventions

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Ultherapy treatment

Focused ultrasound energy delivered below the surface of the skin

Intervention Type DEVICE

Untreated-control / delayed-treatment

Untreated-control, followed by Ultherapy treatment (focused ultrasound energy delivered below the surface of the skin)

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

\- Mild to moderate lower face and/or submental laxity that is amenable to improvement with non-invasive intervention and is not severe enough for surgical intervention;

Exclusion Criteria

* Scarring in area(s) to be treated;
* Any active implants (e.g., pacemakers or defibrillators) in the area(s) to be treated;
* Any metallic implants in area(s) to be treated;
* Any open wounds or lesions in the area(s) to be treated;
* Body mass index (BMI) less than 19 or greater than 30; or
* Gain or loss of ≥ 2 BMI units within the previous 90 days or has the intention to gain or lose ≥ 2 BMI units during the course of the trial.

Minimum Eligible Age

35 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes