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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: October 15, 2012
Last verified: October 2012
History of Changes
  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:

U.S. FDA Resources

Further study details as provided by Ulthera, Inc:

Primary Outcome Measures:
  • Improvement in overall lifting and tightening of skin [ Time Frame: 3 month and 6 month compared to baseline ] [ Designated as safety issue: No ]
    Improvement in overall lifting and tightening of skin determined by qualitative assessment of photographs at 3 month and 6 month compared to baseline based on a masked reviewer assessment.


Secondary Outcome Measures:
  • Evaluation of improvement in jawline definition and submental skin laxity [ Time Frame: 3 and 6 months post treatment ] [ Designated as safety issue: No ]
    Evaluation of 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.


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
No Contacts or Locations Provided
  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
Last Updated: October 15, 2012
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 May 19, 2013