Feasibility Study: Ulthera Treatment of the Buttocks and Thighs

NCT ID: NCT01708460

Last Updated: 2017-11-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-12-31
• Study Completion Date: 2013-07-31

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.

Conditions

Skin Laxity

Keywords

Ulthera® System; Ultherapy™ Treatment; Ulthera, Inc.; Ultrasound treatment for skin tightening

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Ulthera System Treatment

Intervention Type: DEVICE

Focused ultrasound energy delivered below the surface of the skin.

Interventions

Ulthera System Treatment

Focused ultrasound energy delivered below the surface of the skin.

Intervention Type: DEVICE

Other Intervention Names

Ultherapy™

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 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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ulthera, Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Goldberg, MD

Role: PRINCIPAL_INVESTIGATOR

Skin Laser and Surgery Specialist of New York and New Jersey

Locations

Skin Laser and Surgery Specialist of New York and New Jersey

New York, New York, United States

Countries

United States

Other Identifiers

ULT-118

Identifier Type: -

Identifier Source: org_study_id