Evaluation of the Ulthera™ System for Obtaining Lift and Tightening of the Cheek Tissue

This study has been completed.
Sponsor:
Collaborator:
University of Texas Southwestern Medical Center
Information provided by (Responsible Party):
Ulthera, Inc
ClinicalTrials.gov Identifier:
NCT01368835
First received: June 6, 2011
Last updated: January 13, 2014
Last verified: January 2014
  Purpose

The clinical trial evaluates the clinical outcomes associated with the non-invasive treatment to obtain lift and tightening of the cheek tissue and improve jawline definition and submental skin laxity utilizing the Ulthera™ System which delivers ultrasound energy in a focused manner below the surface of the skin


Condition Intervention
Mild to Moderate Skin Laxity on Cheek
Mild to Moderate Skin Laxity on Upper Neck
Mild to Moderate Subcutaneous Fat on Cheek
Mild to Moderate Subcutaneous Fat on Upper Neck
Device: Ulthera treatment

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of the Ulthera™ System For Obtaining Lift and Tightening of the Cheek Tissue and Improvement in Jawline Definition and Submental Skin Laxity

Resource links provided by NLM:


Further study details as provided by Ulthera, Inc:

Primary Outcome Measures:
  • Change in Overall Lifting and Tightening of Treated Tissue on the Lower Face and Submental Regions. [ Time Frame: 90D ] [ Designated as safety issue: No ]
    The percentage of participants assessed to have improvement in skin laxity, i.e., lifted and tightened skin in the areas treated with the Ulthera System, as determined by three masked assessors comparing pre-treatment and 90-days post-treatment photos from 70 subjects who returned for their 90-day follow-up visit.


Secondary Outcome Measures:
  • Change in Submental and Neck Skin Laxity by Quantitative Analysis [ Time Frame: 90D ] [ Designated as safety issue: No ]
    The percentage of participants assessed as having an improvement in tissue lift, i.e., >20mm2 in submental and neck skin laxity, at 90 Days post-treatment compared to baseline based on quantitative analysis.

  • Patient Satisfaction Questionnaire [ Time Frame: 90D ] [ Designated as safety issue: No ]
    Subjects indicated whether they saw improvement, i.e., providing a Yes/No response, in face and neck characteristics at three months (D90) post Ulthera treatment. Pre-treatment and Day 90 post-treatment photographs were available for viewing during the assessment. Subjects also had a mirror in hand for real time assessment. Subjects' Yes/No responses were tabulated.


Other Outcome Measures:
  • Subject Assessment of Pain [ Time Frame: During Ulthera study treatment ] [ Designated as safety issue: Yes ]
    Subject assessment of pain using a validated Numeric Rating Scale (NRS), 0-10, where 0 = no pain and 10=worse pain possible. Subjects' sensory responses to the treatment exposures were recorded using the NRS for each anatomical region.


Enrollment: 103
Study Start Date: July 2010
Study Completion Date: April 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ulthera treatment Device: Ulthera treatment
treatment of cheeks and upper neck area of face

Detailed Description:

The primary objective of this study is to demonstrate the effectiveness of the Ulthera™ System for the non-invasive dermatological treatment to obtain lift and tighten the cheek tissue.

The secondary objective of this study is to demonstrate the effectiveness of the Ulthera™ System for the non-invasive dermatological treatment for improvement in jawline definition and submental skin laxity at 3 and 6 months compared to baseline based on the consensus of the three masked reviewers.

  Eligibility

Ages Eligible for Study:   35 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male or female, aged 35 to 60 years
  • Subject in good health
  • Desire lift and tightening of cheek tissue, improvement of jawline definition or submental skin laxity

Exclusion Criteria:

  • Pregnant or lactating
  • Has an active systemic or local skin disease that may alter wound healing
  • Severe solar elastosis
  • Excessive subcutaneous fat on the cheeks
  • Excessive skin laxity on the lower face and neck
  • Has significant scarring in areas to be treated
  • Has significant open facial wounds or lesions
  • Has severe or cystic acne on the face
  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: NCT01368835

Sponsors and Collaborators
Ulthera, Inc
University of Texas Southwestern Medical Center
Investigators
Principal Investigator: Jeffrey M. Kenkel, MD University of Texas Southwestern Medical Center
  More Information

No publications provided

Responsible Party: Ulthera, Inc
ClinicalTrials.gov Identifier: NCT01368835     History of Changes
Other Study ID Numbers: ULT-106
Study First Received: June 6, 2011
Results First Received: March 25, 2013
Last Updated: January 13, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Cutis Laxa
Skin Diseases, Genetic
Genetic Diseases, Inborn
Connective Tissue Diseases
Skin Diseases

ClinicalTrials.gov processed this record on September 16, 2014