Feasibility Study: Evaluation of the Ulthera® System for Treatment of Abdominal Tissue

November 21, 2017 updated by: Ulthera, Inc

Feasibility Study: Evaluation of the Ulthera® System for Efficacious and Safe Treatment of Laxity/Crepiness and Texture of Abdominal Tissue

Enrolled subjects will receive one UltherapyTM treatment on the abdomen. Follow-up visits will occur at 90 and 180 days post-treatment. Study images will be obtained pre-treatment, immediately post-treatment, and at each follow-up visit.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a prospective, single-center, pilot clinical trial to evaluate the efficacy of the Ulthera® System for improving laxity/crepiness and texture of abdominal tissue. Changes from baseline in the laxity, crepiness and texture of abdominal skin will be assessed at each study follow-up visit. Global Aesthetic Improvement Scale scores, assessments of dermal thickness, and patient satisfaction questionnaires will also be obtained.

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
      • Pasadena, California, United States, 91105
        • Sasaki Advanced Aesthetic Medical Center

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

25 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female, aged 25 to 60 years.
  • Subject in good health.
  • Skin laxity in the abdomen
  • 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.
  • Severe solar elastosis.
  • Excessive subcutaneous fat in the abdomen.
  • Excessive skin laxity on the abdomen.
  • Significant scarring in areas to be treated.
  • Open wounds or lesions in the area to be treated.
  • Inability to understand the protocol or to give informed consent.
  • BMI equal to and greater than 30.

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: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement laxity/crepiness and texture of abdominal tissue
Time Frame: 90 days post-treatment
Determined by a masked, qualitative assessment of photographs at 90 days post treatment compared to baseline
90 days post-treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall aesthetic improvement
Time Frame: 180 days post-treatment
The Global Aesthetic Improvement Scale scores will be obtained from the investigator and subject, comparing post-treatment photos to pre-treatment photos.
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: Gordon Sasaki, MD

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

March 1, 2012

Primary Completion (Actual)

January 1, 2013

Study Completion (Actual)

April 1, 2013

Study Registration Dates

First Submitted

October 15, 2012

First Submitted That Met QC Criteria

October 16, 2012

First Posted (Estimate)

October 17, 2012

Study Record Updates

Last Update Posted (Actual)

November 24, 2017

Last Update Submitted That Met QC Criteria

November 21, 2017

Last Verified

June 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ULT-128

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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