Ultherapy for Buttock Lift

NCT02270892 | Completed

• 1 other identifier: ULT-142
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

Up to 24 subjects will be enrolled and treated. Enrolled subjects will receive two Ulthera® treatments, 90 days apart. Follow-up visits will occur at 90, 180, and 270 days following the last treatment. Study images will be obtained pre-treatment, immediately post-treatment, and at each follow-up visit.

Conditions

Buttock Ptosis

Keywords

Ulthera, Ulthera System, Ultherapy

Outcome Measures

Primary Outcomes (3)

• 90-day quantitative buttock lift

  Post-treatment change from baseline in protocol-defined buttock measurements: * ϒ (gamma) angle: The angle between the turning point between the gluteal sulcus line and the thigh; * β (beta) angle: The angle from the midpoint of the lateral thigh along the gluteal-sulcus line and the most posterior point of the buttock.

  90 days following last treatment

• 180-day quantitative buttock lift

  Post-treatment change from baseline in protocol-defined buttock measurements: * ϒ (gamma) angle: The angle between the turning point between the gluteal sulcus line and the thigh; * β (beta) angle: The angle from the midpoint of the lateral thigh along the gluteal-sulcus line and the most posterior point of the buttock.

  180 days following last treatment

• 270-day quantitative buttock lift

  Post-treatment change from baseline in protocol-defined buttock measurements: * ϒ (gamma) angle: The angle between the turning point between the gluteal sulcus line and the thigh; * β (beta) angle: The angle from the midpoint of the lateral thigh along the gluteal-sulcus line and the most posterior point of the buttock.

  270 days following last treatment

Secondary Outcomes (16)

• 90-day qualitative improvement in buttock ptosis

  90 days following last treatment

• 180-day qualitative improvement in buttock ptosis

  180 days following last treatment

• 270-day qualitative improvement in buttock ptosis

  270 days following last treatment

• 90-day Clinician Buttock Improvement Scale (CBIS)

  90 days following last treatment

• 180-day Clinician Buttock Improvement Scale (CBIS)

  180 days following last treatment

Study Arms (2)

Group A

ACTIVE COMPARATOR

Left side Ulthera treatment

Device: Ulthera treatment

Group B

ACTIVE COMPARATOR

Right side Ulthera treatment

Device: Ulthera treatment

Interventions

Ulthera treatment DEVICE

Focused ultrasound energy delivered below the surface of the skin

Also known as: Ultherapy, Ulthera System Treatment

Group A; Group B

Eligibility Criteria

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

You may qualify if:

• Female, age 18 to 65 years.
• Subject in good health.
• Mild to moderate buttock ptosis based on Investigator evaluation.
• BMI \<25.
• No history of weight gain or loss of greater than 10 pounds within the past year.
• No planned weight loss or gain for the duration of the study.
• No pregnancy within the past year.
• Willingness to refrain from use of aspirin, Ibuprofen, Naproxen or any other NSAID prior to each study treatment and chronic use during the entire post-treatment study period. If a chronic user, a washout period of 4 weeks is required prior to study treatment #1. Washout period for limited acute NSAID use, i.e., a maximum of 2-3 doses, is required in the 2 weeks prior to any study treatment visit.
• No immunosuppressive therapy, e.g., oral steroid treatment, within the past 4 weeks and during the entire post-treatment study period. Washout period, if recent use, for 4 weeks prior to study treatment #1.
• Subject must desire improvement of her buttock ptosis as demonstrated by a Dissatisfaction response on a baseline Patient Satisfaction Questionnaire, i.e., Dissatisfied, Neither Satisfied or Dissatisfied, Slightly Satisfied, Satisfied, Very Satisfied.
• Willingness to refrain from receiving spray tans or using self-tanning lotions from mid-thigh to waist within 2 weeks of any study assessments for the duration of the trial.
• Willingness to avoid as much as possible, direct and prolonged sun exposure from mid-thigh to waist for the duration of the study.
• Willingness to refrain from topical steroid use, tretinoin, caffeine cream and other prescription or over-the-counter cellulite reduction topicals to the affected area 2 weeks prior to study treatment #1 and for the duration of the study period.
• Understands and accepts the obligation not to undergo any other procedures in the areas to be treated through the follow-up period.
• Subjects of childbearing potential must have a negative urine pregnancy test result and must not be lactating at the Baseline Visit 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:

You may not qualify if:

• Radiofrequency, CoolSculpting, liposuction, other energy-based treatment in the area to be treated for body contouring, fat reduction, improvement of cellulite, or reduction of buttock ptosis within 1 year prior to study participation or during the study.
• Short-wave or massage therapy in the area to be treated for treatment of cellulite or buttock ptosis within 3 months prior to study participation or during the study.
• BMI greater than or equal to 25.
• Presence of an active systemic or local skin disease that may affect wound healing.
• Excessive subcutaneous fat in the area to be treated.
• Excessive skin laxity on the area to be treated.
• Severe buttock ptosis.
• Significant scarring or tattoos in the area to be treated that would interfere with assessing results.
• Open wounds or lesions in the area to be treated.
• Inability to understand the protocol or to give informed consent.
• History of chronic drug or alcohol abuse.
• History of autoimmune disease.
• Has a known allergy or a known contraindication to ketorolac tromethamine (Toradol).
• Concurrent therapy that, in the investigator's opinion, would interfere with the evaluation of the safety or efficacy of the study device.
• Subjects who anticipate the need for inpatient surgery or overnight hospitalization during the study.

Sponsors & Collaborators

• Ulthera, Inc: lead

Study Sites (1)

Dermatology Cosmetic Laser Medical Associates of La Jolla, Inc.

La Jolla, California, 92121, United States

Location

Study Officials

• Lisa Misell, PhD

  Ulthera, Inc

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2014
• First Posted: October 21, 2014
• Study Start: August 28, 2014
• Primary Completion: July 22, 2016
• Study Completion: April 3, 2017
• Last Updated: January 31, 2018

Record last verified: 2017-05

Locations

US (1)