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Feasibility Study: Ulthera Treatment of the Buttocks and Thighs

Primary Purpose

Skin Laxity

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Ulthera System Treatment

About this trial

This is an interventional treatment trial for Skin Laxity focused on measuring Ulthera® System, Ultherapy™ Treatment, Ulthera, Inc., Ultrasound treatment for skin tightening

Eligibility Criteria

30 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Skin Laser and Surgery Specialist of New York and New Jersey

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ulthera-treated subjects

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Overall aesthetic improvement.

As determined by GAIS completed by the Investigator and subject.

Overall subject satisfaction.

As determined by subjects' completion of a Patient Satisfaction Questionnaire.

Full Information

NCT ID

NCT01708460

First Posted

October 15, 2012

Last Updated

November 21, 2017

Sponsor

Ulthera, Inc

1. Study Identification

Unique Protocol Identification Number

NCT01708460

Brief Title

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

2. Study Status

Record Verification Date

September 2013

Overall Recruitment Status

Completed

Study Start Date

December 2011 (undefined)

Primary Completion Date

January 2013 (Actual)

Study Completion Date

July 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Ulthera, Inc

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Skin Laxity

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

31 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Ulthera-treated subjects

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

Ulthera System Treatment

Other Intervention Name(s)

Ultherapy™

Intervention Description

Focused ultrasound energy delivered below the surface of the skin.

Primary Outcome Measure Information:

Title

Overall lifting and tightening of the buttocks and thighs.

Description

As determined by a masked, qualitative assessment of photographs at three months post-treatment compared to baseline.

Time Frame

90 days post-treatment

Secondary Outcome Measure Information:

Title

Overall aesthetic improvement.

Description

As determined by GAIS completed by the Investigator and subject.

Time Frame

90 and 180 days post-treatment.

Title

Overall subject satisfaction.

Description

As determined by subjects' completion of a Patient Satisfaction Questionnaire.

Time Frame

90 and 180 days post-treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

30 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

David Goldberg, MD

Organizational Affiliation

Skin Laser and Surgery Specialist of New York and New Jersey

Official's Role

Principal Investigator

Facility Information:

Facility Name

Skin Laser and Surgery Specialist of New York and New Jersey

City

New York

State/Province

New York

ZIP/Postal Code

10022

Country

United States

12. IPD Sharing Statement

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Feasibility Study: Ulthera Treatment of the Buttocks and Thighs

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