Feasibility Study: Lifting and Tightening of the Elbows

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. Identifier: NCT01708382
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:
Up to 20 subjects will be treated. Treated subjects will receive one Ulthera® treatment on the elbows. 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 or disease Intervention/treatment Phase
Skin Laxity Device: Ulthera System Treatment Not Applicable

Detailed Description:
This is a prospective, single-center, pilot clinical trial to evaluate the efficacy of the Ulthera® System to improve skin laxity above the elbows. Masked assessment of pre- and post-treatment photos will be performed. Global Aesthetic Improvement Scale scores and patient satisfaction questionnaires will also be obtained.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Feasibility Study: Evaluation of the Ulthera® System for Lifting and Tightening of the Elbow Tissue - A Feasibility Study
Study Start Date : September 2011
Actual Primary Completion Date : September 2012
Actual Study Completion Date : February 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Ultherapy treatment on the elbows
All enrolled subjects will receive one Ultherapy treatment to the elbows.
Device: Ulthera System Treatment
Focused ultrasound energy delivered below the surface of the skin
Other Name: Ultherapy™

Primary Outcome Measures :
  1. Overall improvement of skin laxity in the areas treated [ Time Frame: 90 days post-treatment ]
    Determined by masked assessment analysis of photographs at 90 days post treatment compared to baseline.

Secondary Outcome Measures :
  1. Aesthetic improvement [ Time Frame: 90 and 180 days post-treatment ]
    GAIS scores will be obtained by the Investigator and subjects at all visits excluding baseline. Additionally, subject satisfaction questionnaires will also be obtained.

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Male or female, age 21 to 65 years.
  • Subject in good health.
  • Mild to moderate skin laxity on the elbows.
  • 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.
  • Subjects of childbearing potential must have a negative urine pregnancy test result and must not be lactating at Visit 1 and be willing and able to use an acceptable method of birth control

Exclusion Criteria:

  • Presence of an active systemic or local skin disease that may affect wound healing.
  • Excessive subcutaneous fat around the elbows.
  • Excessive skin laxity around the elbows.
  • Significant scarring in areas to be treated.
  • Significant open wounds or lesions in the area 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 identifier (NCT number): NCT01708382

United States, New York
New York Cosmetic, Skin and Laser Surgery Center
New York, New York, United States, 10065
Sponsors and Collaborators
Ulthera, Inc
Principal Investigator: Cameron K Rokhsar, MD New York Cosmetic, Skin, and Laser Surgery Center

Responsible Party: Ulthera, Inc Identifier: NCT01708382     History of Changes
Other Study ID Numbers: ULT-108
First Posted: October 17, 2012    Key Record Dates
Last Update Posted: November 24, 2017
Last Verified: June 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:
Cutis Laxa
Skin Diseases, Genetic
Genetic Diseases, Inborn
Connective Tissue Diseases
Skin Diseases