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Feasibility Study: Lifting and Tightening of the Elbows

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ClinicalTrials.gov Identifier: NCT01708382
Recruitment Status : Completed
First Posted : October 17, 2012
Last Update Posted : November 24, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
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
Skin Laxity Device: Ulthera System Treatment

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 Design

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
Primary Completion Date : September 2012
Study Completion Date : February 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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™


Outcome Measures

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.


Eligibility Criteria

Information from the National Library of Medicine

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

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
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): NCT01708382


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

Responsible Party: Ulthera, Inc
ClinicalTrials.gov 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