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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ulthera, Inc
ClinicalTrials.gov Identifier:
NCT01519206
First received: December 8, 2011
Last updated: April 10, 2013
Last verified: April 2013
  Purpose

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 Intervention
Skin Laxity
Device: Ulthera System Treatment

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by Ulthera, Inc:

Primary Outcome Measures:
  • Improvement in overall lifting and tightening of skin [ Time Frame: 90 days post treatment ] [ Designated as safety issue: No ]
    Determined by a masked, qualitative assessment of photographs at three months post-treatment compared to baseline.


Secondary Outcome Measures:
  • Improvement in lower face skin laxity, jawline definition, and/or submental skin laxity. [ Time Frame: 60, 90, 180 days and 1 year post-treatment ] [ Designated as safety issue: No ]
    Assessed by a quantitative measure of submental skin lift, as assessed at all visits.


Enrollment: 32
Study Start Date: August 2011
Study Completion Date: March 2013
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   30 Years to 65 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01519206

Locations
United States, New York
Laser & Skin Surgery Center of NY
New York, New York, United States, 10016
Sponsors and Collaborators
Ulthera, Inc
Investigators
Principal Investigator: Roy Geronemus, M.D. Laser & Skin Surgery Center of NY
  More Information

No publications provided

Responsible Party: Ulthera, Inc
ClinicalTrials.gov Identifier: NCT01519206     History of Changes
Other Study ID Numbers: ULT-124
Study First Received: December 8, 2011
Last Updated: April 10, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Ulthera, Inc:
Ulthera® System
Ultherapy™ Treatment
Ulthera, Inc.

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

ClinicalTrials.gov processed this record on April 22, 2014