Treatment of the Face and Neck With Lower Ulthera System Energy Settings

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ulthera, Inc
ClinicalTrials.gov Identifier:
NCT01713998
First received: October 15, 2012
Last updated: January 6, 2014
Last verified: January 2014
  Purpose

Up to 60 subjects will be enrolled. Enrolled subjects will receive one Ulthera® treatment on the face and neck. Follow-up visits will occur at 90 and 180 days post-treatment. Study images will be obtained pre-treatment, immediately post-treatment, and at each follow-up visit.


Condition Intervention
Skin Laxity
Device: Ulthera System Treatment

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Evaluation of the Ulthera® System for Lifting and Tightening the Face and Neck With Lower Energy Settings

Resource links provided by NLM:


Further study details as provided by Ulthera, Inc:

Primary Outcome Measures:
  • Subjects' Assessment of Pain During Treatment With Lower Energy Settings [ Time Frame: Participants were assessed for the duration of study treatment, an average of 75 minutes ] [ Designated as safety issue: Yes ]

    Subjects' sensory response to the Ulthera treatment exposures were recorded using a validated Numeric Rating Scale (NRS,0-10), for each anatomical region treated and energy settings used, with 0 representing no pain and 10 representing the worst pain possible.

    Pain scores were collected in a consistent manner, following treatment of each section of the face and neck on both sides (submental, submandibular, cheek, periorbital, infraorbital, and forehead), and for each transducer used. Split-face comparisons of pain scores obtained during study treatment by research staff blinded to the energy settings used were completed.


  • Overall Improvement in Skin Laxity on the Face and Neck [ Time Frame: 90 days post-treatment ] [ Designated as safety issue: No ]
    A split-face comparison of improvement in overall lifting and tightening of skin was completed by three masked assessors. Pre-treatment and 90 days post-treatment photos from 45 subjects who returned for their 90-day follow-up visit were reviewed, assessing for improvement in skin laxity, i.e., lifted and tightened skin in the areas treated using treatment energy settings based on subjects' assigned study group.


Secondary Outcome Measures:
  • Quantitative Assessment of Brow Lift at 90 Days Post-treatment [ Time Frame: 90 days post-treatment ] [ Designated as safety issue: No ]
    Quantitative assessment and analysis of brow lift from baseline to 90 days post-treatment was completed comparing brow lift achieved using standard energy settings compared to adjusted energy settings. The number of subjects with 1 mm or more brow lift is reported. Note: Because the submental region was treated using standard energy settings in all study groups, a quantitative analysis of lift in this region between the study groups would most likely not be informative, and therefore was not completed.

  • Subject Assessment of Improvement at 90 Days Post-treatment [ Time Frame: 90 days post-treatment ] [ Designated as safety issue: No ]
    Subjects completed a Patient Assessment Questionnaire at 90 days post-treatment by referring to their image in a mirror, their 90-day post-treatment photos, and their pre-treatment photos, and reporting if any improvement was noted on the right and left sides of their face and neck.

  • Subject Assessment of Improvement at 180 Days Post-treatment [ Time Frame: 180 days post-treatment ] [ Designated as safety issue: No ]
    Subjects completed a Patient Assessment Questionnaire at 180 days post-treatment by referring to their image in a mirror, their 180-day post-treatment photos, and their pre-treatment photos, and reporting if any improvement was noted on the right and left sides of their face and neck.


Enrollment: 47
Study Start Date: September 2011
Study Completion Date: October 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Group A
Subjects will receive an increased density Ulthera System Treatment over the full face but with the energy turned down to the second highest level of four possible energy settings on one side of the face.
Device: Ulthera System Treatment
Focused ultrasound energy delivered below the surface of the skin
Other Name: Ultherapy™
Active Comparator: Group B
Subjects will receive an increased density guideline Ulthera System Treatment over the full face but with the energy turned down to the lowest level of four possible energy settings on one side of the face.
Device: Ulthera System Treatment
Focused ultrasound energy delivered below the surface of the skin
Other Name: Ultherapy™
Active Comparator: Group C
Subjects will receive an increased density guideline Ulthera System Treatment over the full face with the exception that a 4 MHz transducer will be used on the upper face in place of a7 MHz transducer, with the energy turned down to the lowest level of four possible energy settings.
Device: Ulthera System Treatment
Focused ultrasound energy delivered below the surface of the skin
Other Name: Ultherapy™

Detailed Description:

This trial is a prospective, single-site, double-blinded, randomized, split-face design. Subjects will be randomized to one of three treatment groups, receiving treatment using different energy levels. Global Aesthetic Improvement Scale scores and patient satisfaction questionnaires will be obtained.

  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, age 30 to 65 years.
  • Subject in good health.
  • Skin laxity on the face and neck

Exclusion Criteria:

  • Presence of an active systemic or local skin disease that may affect wound healing.
  • Severe solar elastosis.
  • Excessive subcutaneous fat in the face or neck.
  • Excessive skin laxity on the face or neck.
  • Significant scarring in areas to be treated.
  • Open wounds or lesions in the area to be treated.
  • Severe or cystic acne on the area to be treated.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01713998

Locations
United States, Arizona
Ulthera, Inc.
Mesa, Arizona, United States, 85210
Sponsors and Collaborators
Ulthera, Inc
Investigators
Principal Investigator: Steven H Gitt, MD Ulthera, Inc
  More Information

No publications provided

Responsible Party: Ulthera, Inc
ClinicalTrials.gov Identifier: NCT01713998     History of Changes
Other Study ID Numbers: ULT-300
Study First Received: October 15, 2012
Results First Received: June 19, 2013
Last Updated: January 6, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on September 16, 2014