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

Ulthera, Inc1 site in 1 country31 target enrollmentDecember 2011

ConditionsSkin Laxity

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Skin Laxity
Sponsor: Ulthera, Inc
Enrollment: 31
Locations: 1
Primary Endpoint: Overall lifting and tightening of the buttocks and thighs.
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

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.

Registry

clinicaltrials.gov

Start Date

December 2011

End Date

July 2013

Last Updated

8 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Ulthera, Inc

Responsible Party

Sponsor

Eligibility 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
•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.