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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: February 27, 2013
Last verified: February 2013
History of Changes
  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: 90 days post-treatment ] [ Designated as safety issue: No ]
    Assess improvement based on a masked, qualitative assessment of photographs at 90 days post-treatment compared to baseline.


Secondary Outcome Measures:
  • Quantitative improvement in skin laxity [ Time Frame: Participants will be followed up to 180 days post-treatment ] [ Designated as safety issue: No ]
    Assess change in brachial volume based on brachial tissue measurements.

  • Improvement in dermal thickness [ Time Frame: Participants will be followed for up to 180 days following treatment #2. ] [ Designated as safety issue: No ]
    Based on ultrasonic skin analysis

  • Overall aesthetic improvement [ Time Frame: 90 and 180 days post-treatment ] [ Designated as safety issue: No ]
    Based on GAIS scores

  • Patient satisfaction [ Time Frame: 90 and 180 days post-treatment ] [ Designated as safety issue: No ]
    Based on Patient Satisfaction questionnaires


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
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
Last Updated: February 27, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on May 23, 2013