Feasibility Study: Ulthera Treatment of the Buttocks and Thighs

November 21, 2017 updated by: Ulthera, Inc

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

Up to 30 subjects will be enrolled. Enrolled subjects will receive an Ulthera® treatment to one side of the body, treating the lateral buttock region. 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 to improve buttock and thigh skin laxity. Global Aesthetic Improvement Scale scores and patient satisfaction questionnaires will be obtained.

Study Type

Interventional

Enrollment (Actual)

31

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
    • New York
      • New York, New York, United States, 10022
        • Skin Laser and Surgery Specialist of New York and New Jersey

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

30 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female, age 30 to 65 years.
  • Subject in good health.
  • Skin laxity in the buttocks and thighs.
  • Understands and accepts the obligation not to undergo any other procedures in the areas to be treated and/or weight loss 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.
  • Subjects of childbearing potential must have a negative urine pregnancy test result and must not be lactating at Visit 1 and be willing and able to use an acceptable method of birth control (e.g., barrier methods used with a spermicidal agent, hormonal methods, IUD, surgical sterilization, abstinence) during the study. Women will not be considered of childbearing potential if one of the following conditions is documented on the medical history: a) Postmenopausal for at least 12 months prior to study; b) Without a uterus and/or both ovaries; or c) A bilateral tubal ligation at least six months prior to study enrollment.

Exclusion Criteria:

  • Presence of an active systemic or local skin disease that may affect wound healing.
  • BMI equal to or greater than 40.
  • Excessive subcutaneous fat in the buttocks and thighs.
  • Excessive skin laxity in the buttocks and thighs.
  • Significant weight fluctuation (±10 lbs) in the past 6 months.
  • Taking weight-loss medications/supplements.
  • Surgical or non-surgical treatments to the target areas in the last 12 months, e.g., liposuction.
  • Inability to understand the protocol or to give informed consent.

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: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Ulthera-treated subjects
All enrolled subjects will receive one Ultherapy treatment to one side of the body in the lateral buttock region. Following study completion, subjects may elect to receive a balancing treatment to the other side of the body.
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
Overall lifting and tightening of the buttocks and thighs.
Time Frame: 90 days post-treatment
As determined by a masked, qualitative assessment of photographs at three months post-treatment compared to baseline.
90 days post-treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall aesthetic improvement.
Time Frame: 90 and 180 days post-treatment.
As determined by GAIS completed by the Investigator and subject.
90 and 180 days post-treatment.
Overall subject satisfaction.
Time Frame: 90 and 180 days post-treatment
As determined by subjects' completion of a Patient Satisfaction 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: David Goldberg, MD, Skin Laser and Surgery Specialist of New York and New Jersey

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

December 1, 2011

Primary Completion (ACTUAL)

January 1, 2013

Study Completion (ACTUAL)

July 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

September 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ULT-118

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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