Evaluation of the Ulthera® System for Treatment of the Brachia

November 10, 2017 updated by: Ulthera, Inc

Evaluation of the Ulthera® System for Obtaining Lift and Tightening of the Brachia

This study is an evaluation of the Ulthera® System used to treat the upper arms for improvement of brachial ptosis. All enrolled subjects will receive one bilateral upper arm treatment. Follow-up visits will occur at 60, 90 and 180 days post-treatment.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a prospective, non-randomized, clinical trial treating up to 35 subjects. Study photographs of the upper arms will be taken prior to treatment, immediately post-treatment, and at each follow-up visit. Brachial volume and dermal thickness measurements will be obtained.

Study Type

Interventional

Enrollment (Actual)

37

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Pasadena, California, United States, 91105
        • Sasaki Advanced Aesthetic Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 55 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female, aged 19 - 55 years.
  • Subject in good health.
  • Subjects who desire lift and tightening of the brachia and improvement in skin laxity.
  • Mild to moderate laxity of the upper arm.
  • Mild to moderate subcutaneous fat of the upper arm.
  • Mild crepiness of the skin of the upper arm.
  • Understands and accepts the obligation not to undergo any other procedures in the areas to be treated 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.

Exclusion Criteria:

  • Presence of an active systemic or local skin disease that may affect wound healing.
  • Severe solar elastosis.
  • Excessive subcutaneous fat in the upper arm.
  • Excessive skin laxity in the upper arm.
  • Significant scarring in areas to be treated.
  • Significant open wounds or lesions in the treatment areas. 7. Severe or cystic acne in the treatment areas.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Ultherapy™ treatment
Each enrolled subject will receive a bilateral Ultherapy™ treatment of the upper arms
Device: Ulthera® System
Focused ultrasound energy delivered below the surface of the skin.
Other Names:
  • Ulthera, Inc.
  • Ultrasound treatment for skin tightening
  • Ultherapy™ treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement in Obtaining Lift and Tightening of Brachial Skin Laxity
Time Frame: Baseline to 90 days post-treatment
Improvement in overall lifting and tightening of brachial skin laxity as determined by masked, qualitative assessment of photographs at 90 days post-treatment compared to baseline.
Baseline to 90 days post-treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quantitative Improvement in Skin Laxity
Time Frame: Baseline to 90 days post-treatment
Assess change in brachial volume based on brachial tissue measurements.
Baseline to 90 days post-treatment
Change in Dermal Thickness
Time Frame: Baseline to 90 days post-treatment
Based on ultrasonic skin analysis, the change in dermal thickness from baseline to 90 days post-treatment was calculated.
Baseline to 90 days post-treatment
Change in Dermal Thickness
Time Frame: Baseline to180 days post-treatment
Based on ultrasonic skin analysis, the change in dermal thickness from baseline to 180 days post-treatment was calculated.
Baseline to180 days post-treatment
Overall Aesthetic Improvement
Time Frame: Baseline to 60 days post-treatment

Based on Global Aesthetic Improvement Scale (GAIS) Scores; PGAIS completed by a physician assessor, SGAIS completed by the study subject. . The GAIS is a 5-point scale (1-5) describing an overall assessment as follows:

  1. - Very Much Improved
  2. - Much Improved
  3. - Improved
  4. - No Change
  5. - Worse
Baseline to 60 days post-treatment
Overall Aesthetic Improvement
Time Frame: Baseline to 90 days post-treatment

Based on Global Aesthetic Improvement Scale (GAIS) Scores; PGAIS completed by a physician assessor, SGAIS completed by the study subject. . The GAIS is a 5-point scale (1-5) describing an overall assessment as follows:

  1. - Very Much Improved
  2. - Much Improved
  3. - Improved
  4. - No Change
  5. - Worse
Baseline to 90 days post-treatment
Overall Aesthetic Improvement
Time Frame: Baseline to180 days post-treatment

Based on Global Aesthetic Improvement Scale (GAIS) Scores; PGAIS completed by a physician assessor, SGAIS completed by the study subject. . The GAIS is a 5-point scale (1-5) describing an overall assessment as follows:

  1. - Very Much Improved
  2. - Much Improved
  3. - Improved
  4. - No Change
  5. - Worse
Baseline to180 days post-treatment
Patient Satisfaction
Time Frame: Baseline to 90 days post-treatment
Patient satisfaction was determined by scores on a patient satisfaction questionnaire (PSQ) completed at 90 days post-treatment. Subjects indicated how satisfied they were with study treatment, i.e., Very Satisfied, Satisfied, Dissatisfied, Very Dissatisfied. Pre-treatment and Day 90 post-treatment photographs were available for viewing during the assessment.
Baseline to 90 days post-treatment
Patient Satisfaction
Time Frame: Baseline to 180 days post-treatment
Patient satisfaction was determined by scores on a patient satisfaction questionnaire (PSQ) completed at 180 days post-treatment. Subjects indicated how satisfied they were with study treatment, i.e., Very Satisfied, Satisfied, Dissatisfied, Very Dissatisfied. Pre-treatment and Day 90 post-treatment photographs were available for viewing during the assessment.
Baseline to 180 days post-treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ulthera, Inc

Investigators

  • Principal Investigator: Gordon Sasaki, MD FACS, Sasaki Advanced Aesthetic Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2011

Primary Completion (ACTUAL)

February 1, 2012

Study Completion (ACTUAL)

May 1, 2012

Study Registration Dates

First Submitted

October 15, 2012

First Submitted That Met QC Criteria

October 22, 2012

First Posted (ESTIMATE)

October 25, 2012

Study Record Updates

Last Update Posted (ACTUAL)

December 11, 2017

Last Update Submitted That Met QC Criteria

November 10, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • ULT-114

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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