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

November 22, 2017 updated by: Ulthera, Inc

Feasibility Study: Evaluation of the Ulthera® System for Lifting and Tightening of the Décolleté

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Diego, California, United States, 92121
        • Goldman, Butterwick, Fitzpatrick & Groff of Dermatology Cosmetic Laser

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ultherapy™ treatment on the décolleté
All enrolled subjects will receive the study treatment.
Device: Ulthera® System
Focused ultrasound energy delivered below the surface of the skin.
Other Names:
  • Ultherapy™ treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement in overall lifting and tightening of skin
Time Frame: 90 days post-treatment
Lifting and tightening of décolleté skin as determined by a masked, qualitative assessment of photographs at 90 days posttreatment compared to baseline.
90 days post-treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Skin Laxity of the Décolleté
Time Frame: 90 and 180 days post-treatment
The amount of skin laxity will be assessed using the Fabi/Bolton 5-Point Chest Wrinkle Scale. Skin laxity will be assessed at each follow-up visit compared to baseline.
90 and 180 days post-treatment
Bilateral chest measurements
Time Frame: 90 and 180 days post-treatment
Measurements from mid-clavicle to nipple obtained at each follow-up visit compared to baseline to assess for lifting and tightening of skin.
90 and 180 days post-treatment
Overall aesthetic improvement
Time Frame: 90 and 180 days post-treatment
Based on Global Aesthetic Improvement Scale (GAIS) scores.
90 and 180 days post-treatment
Patient satisfaction
Time Frame: 90 and 180 days post-treatment
Subject-completed questionnaire.
90 and 180 days post-treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ulthera, Inc

Investigators

  • Principal Investigator: Michael Goldman, MD, Goldman, Butterwick, Fitzpatrick & Groff of Dermatology Cosmetic Laser

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2011

Primary Completion (Actual)

January 1, 2012

Study Completion (Actual)

May 1, 2012

Study Registration Dates

First Submitted

December 1, 2011

First Submitted That Met QC Criteria

December 2, 2011

First Posted (Estimate)

December 5, 2011

Study Record Updates

Last Update Posted (Actual)

November 24, 2017

Last Update Submitted That Met QC Criteria

November 22, 2017

Last Verified

June 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ULT-105

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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