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

October 15, 2012
February 27, 2013
June 2011
February 2012   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01713933 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Evaluation of the Ulthera® System for Treatment of the Brachia
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.

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.

Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Brachial Ptosis
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
Experimental: Ultherapy™ treatment
Each enrolled subject will receive a bilateral Ultherapy™ treatment of the upper arms
Intervention: Device: Ulthera® System
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
37
May 2012
February 2012   (final data collection date for primary outcome measure)

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.
Both
19 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01713933
ULT-114
No
Ulthera, Inc
Ulthera, Inc
Not Provided
Principal Investigator: Gordon Sasaki, MD FACS Sasaki Advanced Aesthetic Medical Center
Ulthera, Inc
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP