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Lifting and Tightening of the Face and Neck Following an Increased Density Treatment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01519206
Recruitment Status : Completed
First Posted : January 26, 2012
Results First Posted : June 2, 2014
Last Update Posted : December 11, 2017
Sponsor:
Information provided by (Responsible Party):
Merz North America, Inc. ( Ulthera, Inc )

Study Description
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Brief Summary:
The purpose of this study is to evaluate the Ulthera® System for obtaining lift and tightening of the cheek tissue, reduction of jowling, and improving jawline definition and/or submental skin laxity when increased density treatment is applied.

Condition or disease Intervention/treatment Phase
Skin Laxity Device: Ulthera System Treatment Not Applicable

Detailed Description:
All enrolled study subjects will receive one full face and neck Ultherapy™ treatment. Pre- and post-treatment photos will be taken. Subjects will be required to return for follow-up visits at 60 days, 90 days, 180 days and 1 year following treatment.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of the Efficacy and Safety of the Ulthera® System for Lifting and Tightening of the Face and Neck Following an Increased Density Treatment.
Study Start Date : August 2011
Actual Primary Completion Date : February 2012
Actual Study Completion Date : March 2013

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Ultherapy treatment
Ulthera System Treatment
 Device: Ulthera System Treatment
Focused ultrasound energy delivered below the surface of the skin.
Other Names:
  • Ultherapy™
  • Ulthera, Inc.
  • Ultrasound treatment for skin tightening


Outcome Measures
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Primary Outcome Measures :
  1. Improvement in Overall Lifting and Tightening of Skin [ Time Frame: Baseline to 90 days post treatment ]
    Improvement in overall lifting and tightening of skin was completed by three masked assessors, completing a qualitative assessment of pre- and post-treatment photographs. Masked photo pairs of pre/post treatment photos of each treated subject were provided to each assessor. Each photo pair was consistent in lighting, position, focus. The visit interval of each photo was NOT marked. Each assessor's review was completed independently, with no input from others, assessing the photos for improvement. If improvement was seen, the blinded assessor was to choose the post-treatment photo. Categories of assessment included Improved, No Change, or Incorrect post-treatment photo chosen. The majority assessment among the 3 blinded assessors for each subject was reported.


Secondary Outcome Measures :
  1. Overall Aesthetic Improvement at 60 Days, 90 Days, 180 Days and 1 Year Post-treatment. [ Time Frame: Baseline to 60 days, 90 days, 180 days and 1 year post-treatment ]

    Improvement was assessed based on Global Aesthetic Improvement Scale (GAIS) scores. The GAIS was completed based on a live assessment of the subject and a photographic assessment comparing post-treatment photos to baseline photos. The PGAIS was completed by a clinician assessor; SGAIS was 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

  2. Subjects' Assessment of Pain [ Time Frame: During Ulthera treatment ]
    Subjects' sensory response to the Ulthera treatment exposures were recorded for each anatomical region treated using a validated Numeric Rating Scale (0-10), with 1 representing no pain and 10 representing the worst pain possible. Subjects rated pain for each transducer, in each treatment region. For statistical analyses, NRS scores were averaged for each transducer depth.

  3. Subject Satisfaction at 90 Days, 180 Days and 1 Year Post-treatment [ Time Frame: Baseline to 90 days, 180 days and 1 year post-treatment ]
    Subject satisfaction was determined by scores on a patient satisfaction questionnaire (PSQ) completed at 90 days, 180 days and 1 year post-treatment. Subjects indicated how satisfied they were with their study treatment, i.e., Very Satisfied, Satisfied, Dissatisfied, Very Dissatisfied. Pre-treatment and post-treatment photographs were available for viewing at each follow-up visit interval. Subjects also had a mirror available for real time assessment, comparing their image in the mirror with pre-treatment and post-treatment photos.


Eligibility Criteria
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Ages Eligible for Study:   30 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male or female, aged 30 to 65 years
  • Subject in good health
  • Desires lift and tightening of cheek tissue, reduction of jowling, improvement of jawline definition and/or submental skin laxity
  • Understands and accepts the obligation not to undergo any other procedures in the areas to be treated through the followup 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 on the cheeks
  • Excessive skin laxity on the lower face and neck
  • Significant scarring in areas to be treated
  • Significant open facial wounds or lesions
  • Severe or cystic acne on the face
  • Presence of a metal stent or implant in the facial area to be treated, a pacemaker, or cochlear implants
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01519206


Locations
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United States, New York
Laser & Skin Surgery Center of NY
New York, New York, United States, 10016
Sponsors and Collaborators
Ulthera, Inc
Investigators
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Principal Investigator: Roy Geronemus, M.D. Laser & Skin Surgery Center of NY
More Information
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Responsible Party: Ulthera, Inc
ClinicalTrials.gov Identifier: NCT01519206    
Other Study ID Numbers: ULT-124
First Posted: January 26, 2012    Key Record Dates
Results First Posted: June 2, 2014
Last Update Posted: December 11, 2017
Last Verified: November 2017
Keywords provided by Merz North America, Inc. ( Ulthera, Inc ):
Ulthera® System
Ultherapy™ Treatment
Ulthera, Inc.
Additional relevant MeSH terms:
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Cutis Laxa
Skin Diseases, Genetic
Genetic Diseases, Inborn
Connective Tissue Diseases
Skin Diseases