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

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ClinicalTrials.gov Identifier: NCT01713907
Recruitment Status : Terminated (Inadequate study staff to appropriately manage trial.)
First Posted : October 25, 2012
Last Update Posted : November 24, 2017
Information provided by (Responsible Party):
Merz North America, Inc. ( Ulthera, Inc )

Brief Summary:
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 or disease Intervention/treatment
Wrinkles Rhytids Skin Laxity Device: Ulthera® Treatment

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
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
Study Start Date : June 2011
Primary Completion Date : October 2011
Study Completion Date : January 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. 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 :
  1. 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.

  2. Overall patient satisfaction [ Time Frame: 90 and 180 day post-treatment ]
    Determined based on Patient Satisfaction and Quality of Life questionnaire scores.

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

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

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

Responsible Party: Ulthera, Inc
ClinicalTrials.gov Identifier: NCT01713907     History of Changes
Other Study ID Numbers: ULT-109
First Posted: October 25, 2012    Key Record Dates
Last Update Posted: November 24, 2017
Last Verified: February 2013

Keywords provided by Merz North America, Inc. ( 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