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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

June 6, 2011
January 13, 2014
July 2010
December 2010   (final data collection date for primary outcome measure)
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.
Not Provided
Complete list of historical versions of study NCT01368835 on ClinicalTrials.gov Archive Site
  • 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.
Not Provided
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.
Not Provided
 
Evaluation of the Ulthera™ System for Obtaining Lift and Tightening of the Cheek Tissue
Evaluation of the Ulthera™ System For Obtaining Lift and Tightening of the Cheek Tissue and Improvement in Jawline Definition and Submental Skin Laxity

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

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.

Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • 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
treatment of cheeks and upper neck area of face
Experimental: Ulthera treatment
Intervention: Device: Ulthera treatment
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
103
April 2011
December 2010   (final data collection date for primary outcome measure)

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
Both
35 Years to 60 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01368835
ULT-106
Yes
Ulthera, Inc
Ulthera, Inc
University of Texas Southwestern Medical Center
Principal Investigator: Jeffrey M. Kenkel, MD University of Texas Southwestern Medical Center
Ulthera, Inc
January 2014

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