Feasibility Study: Ulthera Treatment of the Buttocks and Thighs

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01708460
Recruitment Status : Completed
First Posted : October 17, 2012
Last Update Posted : November 24, 2017
Information provided by (Responsible Party):
Merz North America, Inc. ( Ulthera, Inc )

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Skin Laxity Device: Ulthera System Treatment Not Applicable

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  (Clinical Trial)
Actual Enrollment : 31 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Feasibility Study: Evaluation of the Ulthera® System for Lifting and Tightening the Buttocks and Thighs
Study Start Date : December 2011
Actual Primary Completion Date : January 2013
Actual Study Completion Date : July 2013

Resource links provided by the National Library of Medicine

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 Name: Ultherapy™

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. Overall aesthetic improvement. [ Time Frame: 90 and 180 days post-treatment. ]
    As determined by GAIS completed by the Investigator and subject.

  2. Overall subject satisfaction. [ Time Frame: 90 and 180 days post-treatment ]
    As determined by subjects' completion of a Patient Satisfaction Questionnaire.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   30 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01708460

United States, New York
Skin Laser and Surgery Specialist of New York and New Jersey
New York, New York, United States, 10022
Sponsors and Collaborators
Ulthera, Inc
Principal Investigator: David Goldberg, MD Skin Laser and Surgery Specialist of New York and New Jersey

Responsible Party: Ulthera, Inc Identifier: NCT01708460     History of Changes
Other Study ID Numbers: ULT-118
First Posted: October 17, 2012    Key Record Dates
Last Update Posted: November 24, 2017
Last Verified: September 2013

Keywords provided by Merz North America, Inc. ( Ulthera, Inc ):
Ulthera® System
Ultherapy™ Treatment
Ulthera, Inc.
Ultrasound treatment for skin tightening

Additional relevant MeSH terms:
Cutis Laxa
Skin Diseases, Genetic
Genetic Diseases, Inborn
Connective Tissue Diseases
Skin Diseases