Feasibility Study: Evaluation of the Ulthera® System for Treatment of the Décolleté

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2012-05-31

Brief Summary

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Up to 20 subjects will be enrolled. Subjects will receive treatment of the décolleté using the Ulthera® System. Subjects will be return for follow-up visits at 90 and 180 days post-treatment. The study will evaluate the effectiveness of the Ulthera® System to lift and tighten the skin of the décolleté region.

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Detailed Description

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This is a prospective, single-center study. Baseline Fabi/Bolton 5-Point Chest Wrinkle scale scores and chest measurements will be assessed prior to study treatment. Study images will be obtained pre-treatment, immediate post-treatment, and at each follow-up visit.

Conditions

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Skin Laxity of the décolleté

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Ultherapy™ treatment on the décolleté

All enrolled subjects will receive the study treatment.

Group Type EXPERIMENTAL

Ulthera® System

Intervention Type DEVICE

Focused ultrasound energy delivered below the surface of the skin.

Interventions

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Ulthera® System

Focused ultrasound energy delivered below the surface of the skin.

Intervention Type DEVICE

Other Intervention Names

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Ultherapy™ treatment

Eligibility Criteria

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Inclusion Criteria

* Female, aged 35 to 60 years.
* Subject in good health.
* Moderate to severe (grade of ≥3 on Fabi/Bolton scale) skin laxity on the décolleté.
* Understands and accepts the obligation not to undergo any other procedures in the areas to be treated through the follow-up period.
* Willingness and ability to comply with protocol requirements, including returning for follow-up visits and abstaining from exclusionary procedures for the duration of the study.

Exclusion Criteria

* Presence of an active systemic or local skin disease that may affect wound healing.
* Scarring in areas to be treated.
* Tattoos in the areas to be treated.
* Patients with ports or defibrillators.
* Breast size \>400cc each as measured by water displacement method.
* History of breast reduction surgery.
* Any open wounds or lesions in the area.
* Active and severe inflammatory acne in the region to be treated.
* Patients who have a history with keloid formation or hypertropic scarring

Minimum Eligible Age

35 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes