Feasibility Study: Ulthera Treatment of the Buttocks and Thighs

NCT01708460 | Completed

• 1 other identifier: ULT-118
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Skin Laxity

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Overall aesthetic improvement.

  90 and 180 days post-treatment.

• Overall subject satisfaction.

  90 and 180 days post-treatment

Study Arms (1)

Ulthera-treated subjects

EXPERIMENTAL

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

Interventions

Ulthera System Treatment DEVICE

Focused ultrasound energy delivered below the surface of the skin.

Also known as: Ultherapy™

Ulthera-treated subjects

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ulthera, Inc: lead

Study Sites (1)

Skin Laser and Surgery Specialist of New York and New Jersey

New York, New York, 10022, United States

Location

MeSH Terms

Conditions

Cutis Laxa

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Study Officials

• David Goldberg, MD

  Skin Laser and Surgery Specialist of New York and New Jersey

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2012
• First Posted: October 17, 2012
• Study Start: December 1, 2011
• Primary Completion: January 1, 2013
• Study Completion: July 1, 2013
• Last Updated: November 24, 2017

Record last verified: 2013-09

Locations

US (1)