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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:
ClinicalTrials.gov Identifier:
NCT01713907
First Posted: October 25, 2012
Last Update Posted: February 28, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Ulthera, Inc
  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: Intervention Model: Single Group Assignment
Masking: None (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 ]
    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 ]
    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 ]
    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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   30 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
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): 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

Responsible Party: Ulthera, Inc
ClinicalTrials.gov Identifier: NCT01713907     History of Changes
Other Study ID Numbers: ULT-109
First Submitted: October 15, 2012
First Posted: October 25, 2012
Last Update Posted: February 28, 2013
Last Verified: February 2013

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