Feasibility Study: Ulthera Treatment of the Buttocks and Thighs

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ulthera, Inc
ClinicalTrials.gov Identifier:
NCT01708460
First received: October 15, 2012
Last updated: September 9, 2013
Last verified: September 2013
  Purpose

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 Intervention
Skin Laxity
Device: Ulthera System Treatment

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Feasibility Study: Evaluation of the Ulthera® System for Lifting and Tightening the Buttocks and Thighs

Resource links provided by NLM:


Further study details as provided by Ulthera, Inc:

Primary Outcome Measures:
  • Overall lifting and tightening of the buttocks and thighs. [ Time Frame: 90 days post-treatment ] [ Designated as safety issue: No ]
    As determined by a masked, qualitative assessment of photographs at three months post-treatment compared to baseline.


Secondary Outcome Measures:
  • Overall aesthetic improvement. [ Time Frame: 90 and 180 days post-treatment. ] [ Designated as safety issue: No ]
    As determined by GAIS completed by the Investigator and subject.

  • Overall subject satisfaction. [ Time Frame: 90 and 180 days post-treatment ] [ Designated as safety issue: No ]
    As determined by subjects' completion of a Patient Satisfaction Questionnaire.


Enrollment: 31
Study Start Date: December 2011
Study Completion Date: July 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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™

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.

  Eligibility

Ages Eligible for Study:   30 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01708460

Locations
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
Investigators
Principal Investigator: David Goldberg, MD Skin Laser and Surgery Specialist of New York and New Jersey
  More Information

No publications provided

Responsible Party: Ulthera, Inc
ClinicalTrials.gov Identifier: NCT01708460     History of Changes
Other Study ID Numbers: ULT-118
Study First Received: October 15, 2012
Last Updated: September 9, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by 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

ClinicalTrials.gov processed this record on July 29, 2014