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Evaluation of the Ulthera® System for Treatment of the Brachia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ulthera, Inc
ClinicalTrials.gov Identifier:
NCT01713933
First received: October 15, 2012
Last updated: April 25, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention
Brachial Ptosis
Device: Ulthera® System

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of the Ulthera® System for Obtaining Lift and Tightening of the Brachia

Further study details as provided by Ulthera, Inc:

Primary Outcome Measures:
  • Improvement in Obtaining Lift and Tightening of Brachial Skin Laxity [ Time Frame: Baseline to 90 days post-treatment ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Quantitative Improvement in Skin Laxity [ Time Frame: Baseline to 90 days post-treatment ] [ Designated as safety issue: No ]
    Assess change in brachial volume based on brachial tissue measurements.

  • Change in Dermal Thickness [ Time Frame: Baseline to 90 days post-treatment ] [ Designated as safety issue: No ]
    Based on ultrasonic skin analysis, the change in dermal thickness from baseline to 90 days post-treatment was calculated.

  • Change in Dermal Thickness [ Time Frame: Baseline to180 days post-treatment ] [ Designated as safety issue: No ]
    Based on ultrasonic skin analysis, the change in dermal thickness from baseline to 180 days post-treatment was calculated.

  • Overall Aesthetic Improvement [ Time Frame: Baseline to 60 days post-treatment ] [ Designated as safety issue: No ]

    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

  • Overall Aesthetic Improvement [ Time Frame: Baseline to 90 days post-treatment ] [ Designated as safety issue: No ]

    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

  • Overall Aesthetic Improvement [ Time Frame: Baseline to180 days post-treatment ] [ Designated as safety issue: No ]

    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

  • Patient Satisfaction [ Time Frame: Baseline to 90 days post-treatment ] [ Designated as safety issue: No ]
    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.

  • Patient Satisfaction [ Time Frame: Baseline to 180 days post-treatment ] [ Designated as safety issue: No ]
    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.


Enrollment: 37
Study Start Date: June 2011
Study Completion Date: May 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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® System
  • Ultherapy™ treatment
  • Ulthera, Inc.
  • Ultrasound treatment for skin tightening

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.

  Eligibility

Ages Eligible for Study:   19 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01713933

Locations
United States, California
Sasaki Advanced Aesthetic Medical Center
Pasadena, California, United States, 91105
Sponsors and Collaborators
Ulthera, Inc
Investigators
Principal Investigator: Gordon Sasaki, MD FACS Sasaki Advanced Aesthetic Medical Center
  More Information

No publications provided

Responsible Party: Ulthera, Inc
ClinicalTrials.gov Identifier: NCT01713933     History of Changes
Other Study ID Numbers: ULT-114
Study First Received: October 15, 2012
Results First Received: January 13, 2014
Last Updated: April 25, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Ulthera, Inc:
Ulthera® System
Ultherapy™ treatment
Ulthera, Inc.

ClinicalTrials.gov processed this record on November 20, 2014