Evaluation of the Ulthera® System for Treatment of the Face and Neck

This study has been terminated.
(Inadequate study staff to appropriately manage trial.)
Sponsor:
Information provided by (Responsible Party):
Ulthera, Inc
ClinicalTrials.gov Identifier:
NCT01713907
First received: October 15, 2012
Last updated: February 27, 2013
Last verified: February 2013
  Purpose

Up to 15 subjects will be enrolled. Enrolled subjects will receive one Ulthera® treatment on the face and neck. Follow-up visits will occur at 45, 90 and 180 days post-treatment. Study images will be obtained pre-treatment, immediately post-treatment, and at each follow-up visit.


Condition Intervention
Wrinkles
Rhytids
Skin Laxity
Device: Ulthera® 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 Ulthera® System for Obtaining Lift and Tightening of the Facial Tissue and Improvement in Jawline Definition and Submental Skin Laxity

Resource links provided by NLM:


Further study details as provided by Ulthera, Inc:

Primary Outcome Measures:
  • Improvement in facial wrinkles and lifting and tightening of skin [ Time Frame: 90 days post-treatment ] [ Designated as safety issue: No ]
    Outcome measure determined based on a masked, qualitative assessment of standardized photographs at 90 days post-treatment compared to baseline


Secondary Outcome Measures:
  • Overall aesthetic improvement [ Time Frame: Participants will be followed up to 180 days post-treatment ] [ Designated as safety issue: No ]
    Aesthetic improvement determined based on GAIS scores at follow-up, and the change in facial pigmentation and Fitzpatrick Facial Wrinkle Scale scores from baseline.

  • Overall patient satisfaction [ Time Frame: 90 and 180 day post-treatment ] [ Designated as safety issue: No ]
    Determined based on Patient Satisfaction and Quality of Life questionnaire scores.


Enrollment: 15
Study Start Date: June 2011
Study Completion Date: January 2012
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ulthera® treatment
All enrolled subjects will receive one full face and neck Ulthera® treatment.
Device: Ulthera® Treatment
Focused ultrasound energy delivered below the surface of the skin.
Other Names:
  • Ultherapy™ System
  • Ulthera, Inc.

Detailed Description:

This is a prospective, single-center, pilot clinical trial to evaluate the efficacy of the Ulthera® System to improve jawline definition and submental skin laxity. Changes from baseline in the Fitzpatrick Facial Wrinkle Scale and facial pigmentation will be assessed at study follow-up visits. Global Aesthetic Improvement Scale scores, patient satisfaction questionnaires, and quality of life 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, aged 30 to 65 years.
  • Subject in good health.
  • Score of 1 to 6 on the Fitzpatrick's Classification of Wrinkling Scale.
  • Mild to moderate rhytids in the periorbital or perioral region.
  • Mild to moderate laxity in the areas to be treated, which includes length and depth of lines.
  • Mild to moderate vertical perioral lines
  • Mild to moderate marionette lines.
  • Subjects who desire lift and tightening of periorbital, perioral, and cheek tissue, improvement in 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 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 on the cheek.
  • Excessive skin laxity on the lower face and neck.
  • Deep wrinkles, numerous lines, with or without redundant skin in the areas to be treated.
  • Excessive hooding with or without redundant skin in the areas to be treated.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01713907

Locations
United States, Maryland
Dermatology, Cosmetic & Laser Surgery
Rockville, Maryland, United States, 20852
Sponsors and Collaborators
Ulthera, Inc
Investigators
Principal Investigator: Hema Sundaram, MD Dermatology, Cosmetic & Laser Surgery
  More Information

No publications provided

Responsible Party: Ulthera, Inc
ClinicalTrials.gov Identifier: NCT01713907     History of Changes
Other Study ID Numbers: ULT-109
Study First Received: October 15, 2012
Last Updated: February 27, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Ulthera, Inc:
Ultherapy™ treatment
Ulthera® System
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 April 17, 2014