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

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ClinicalTrials.gov Identifier: NCT01708512
Recruitment Status : Completed
First Posted : October 17, 2012
Last Update Posted : November 24, 2017
Information provided by (Responsible Party):
Merz North America, Inc. ( Ulthera, Inc )

Brief Summary:
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 or disease Intervention/treatment Phase
Skin Laxity Device: Ulthera System Treatment Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Feasibility Study: Evaluation of the Ulthera® System for Lifting and Tightening of Facial and Neck Skin Laxity Using a Customized, High-Density and Vectoring Treatment Approach
Study Start Date : April 2012
Actual Primary Completion Date : December 2012
Actual Study Completion Date : July 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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™

Primary Outcome Measures :
  1. Improvement in overall lifting and tightening of the skin [ Time Frame: 90 days post-treatment ]
    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 :
  1. Overall aesthetic improvement [ Time Frame: 365 days post-treatment ]
    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.

Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01708512

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United States, Washington
Premier Clinical Research
Spokane, Washington, United States, 99204
Sponsors and Collaborators
Ulthera, Inc
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Principal Investigator: William P Werschler, MD
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Ulthera, Inc
ClinicalTrials.gov Identifier: NCT01708512    
Other Study ID Numbers: ULT-130
First Posted: October 17, 2012    Key Record Dates
Last Update Posted: November 24, 2017
Last Verified: September 2013
Keywords provided by Merz North America, Inc. ( Ulthera, Inc ):
Ulthera® System
Ultherapy™ Treatment
Ulthera, Inc.
Ultrasound treatment for skin tightening
Additional relevant MeSH terms:
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Cutis Laxa
Skin Diseases, Genetic
Genetic Diseases, Inborn
Connective Tissue Diseases
Skin Diseases