Clinical trial NCT01708460: Feasibility Study: Ulthera Treatment of the Buttocks and Thighs
Official title: Feasibility Study: Evaluation of the Ulthera® System for Lifting and Tightening the Buttocks and Thighs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skin Laxity
Keywords: Ulthera® System
Ultherapy™ Treatment
Ulthera, Inc.
Ultrasound treatment for skin tightening
Lead sponsor: Merz North America, Inc.
Sponsor class: INDUSTRY
First posted: 2012-10-17
Enrollment: 31
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Overall lifting and tightening of the buttocks and thighs.
timeFrame: 90 days post-treatment
Secondary outcomes:
measure: Overall aesthetic improvement.
timeFrame: 90 and 180 days post-treatment.
measure: Overall subject satisfaction.
timeFrame: 90 and 180 days post-treatment
Other outcomes:
Locations:
city: New York
country: United States
facility: Skin Laser and Surgery Specialist of New York and New Jersey
state: New York
Study officials:
affiliation: Skin Laser and Surgery Specialist of New York and New Jersey
name: David Goldberg, MD
role: PRINCIPAL_INVESTIGATOR
References: