Feasibility Study: Ulthera Treatment of the Buttocks and Thighs

Skin Laxity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01708460
• Other study ID #: ULT-118
• Status: Completed
• Phase: N/A
• First received: October 15, 2012
• Last updated: November 21, 2017
• Start date: December 2011
• Est. completion date: July 2013

Study information

• Verified date: September 2013
• Source: Merz Pharmaceuticals, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: July 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cutis Laxa
• Skin Laxity

Intervention

Device:
• Ulthera System Treatment
Focused ultrasound energy delivered below the surface of the skin.

Locations

Country	Name	City	State
United States	Skin Laser and Surgery Specialist of New York and New Jersey	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Ulthera, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall lifting and tightening of the buttocks and thighs.	As determined by a masked, qualitative assessment of photographs at three months post-treatment compared to baseline.	90 days post-treatment
Secondary	Overall aesthetic improvement.	As determined by GAIS completed by the Investigator and subject.	90 and 180 days post-treatment.
Secondary	Overall subject satisfaction.	As determined by subjects' completion of a Patient Satisfaction Questionnaire.	90 and 180 days post-treatment