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Higher Density Ulthera® System Treatment With Vectoring for Treatment of the Face and Neck

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Ulthera, Inc
ClinicalTrials.gov Identifier:
NCT01708512
First received: October 15, 2012
Last updated: February 27, 2013
Last verified: February 2013
History of Changes
  Purpose

All enrolled subject will receive one Ultherapy™ treatment. Study images will be obtained pre-treatment, immediate post-treatment, and at each study follow-up visit. Enrolled subjects will return for follow-up visits at 90 days, 180 days and 365 days post-treatment.


Condition Intervention
Skin Laxity
 Device: Ulthera System Treatment

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of the Ulthera® System for Lifting and Tightening of Facial and Neck Skin Laxity Using a Customized, High-Density and Vectoring Treatment Approach

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 the skin [ Time Frame: 90 days post-treatment ] [ Designated as safety issue: No ]
    As determined by a masked, qualitative assessment of photographs at 90 days post treatment compared to baseline. The clinical response of Ulthera treatment will be assessed by comparing photographic images taken before and after the procedure.


Secondary Outcome Measures:
  • Overall aesthetic improvement [ Time Frame: 365 days post-treatment ] [ Designated as safety issue: No ]
    Global Aesthetic Improvement Scale scores will be obtained from the Investigator and subject, assessing improvement in skin laxity based on a comparison of post-treatment photos to pre-treatment photos.


Estimated Enrollment: 20
Study Start Date: April 2012
Estimated Study Completion Date: September 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ultherapy™ study treatment
Each subject will receive a customized, high-density, vectored Ulthera System Treatment.
 Device: Ulthera System Treatment
Focused ultrasound energy delivered below the surface of the skin
Other Name: Ultherapy™

Detailed Description:

This is a prospective, single-center clinical trial to evaluate the efficacy of the Ulthera® System to provide a customized, high-density, vectored Ultherapy™ treatment to lift and tighten the skin of the face and neck. Skin laxity changes from baseline will be assessed at study follow-up visits. Global Aesthetic Improvement Scale scores and patient satisfaction questionnaires will also be obtained.

  Eligibility

Ages Eligible for Study:   25 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male or female, aged 25 to 60 years.
  • Subject in good health.
  • Skin laxity in the area(s) to be treated.
  • Understands and accepts the obligation not to undergo any other procedures in the area(s) to be treated through the follow-up 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 in the area(s) to be treated.
  • Excessive skin laxity on the area(s) to be treated.
  • Significant scarring in area(s) to be treated.
  • Open wounds or lesions in the area(s) to be treated.
  • Severe or cystic acne on the area(s) to be treated.
  • Presence of a metal stent or implant in the area(s) to be treated.
  • Inability to understand the protocol or to give informed consent.
  • BMI equal to and greater than 30.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01708512

Locations
United States, Washington
Premier Clinical Research
Spokane, Washington, United States, 99204
Sponsors and Collaborators
Ulthera, Inc
Investigators
Principal Investigator: William P Werschler, MD
  More Information

No publications provided

Responsible Party: Ulthera, Inc
ClinicalTrials.gov Identifier: NCT01708512     History of Changes
Other Study ID Numbers: ULT-130
Study First Received: October 15, 2012
Last Updated: February 27, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Ulthera, Inc:
Ulthera® System
Ultherapy™ Treatment
Ulthera, Inc.
Ultrasound treatment for skin tightening

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

ClinicalTrials.gov processed this record on May 16, 2013