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Trial record 6 of 47 for:    "cutis laxa"

Feasibility Study: Evaluation of the Ulthera® System for Treatment of the Knees

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ClinicalTrials.gov Identifier: NCT01708434
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:
Enrolled subjects will receive one bilateral Ulthera® treatment on the knees. Up to 30 subjects will be enrolled. Study photos will be obtained prior to study treatment, immediately following study treatment, and at each post-treatment follow-up visit. Follow-up visits will occur at 90 and 180 days post-treatment.

Condition or disease Intervention/treatment
Skin Laxity Device: Ulthera® System

Detailed Description:
This pilot study is a prospective, single-center clinical trial of the Ulthera® System for treating skin laxity on the knees. Global Aesthetic Improvement Scale scores and Patient Satisfaction questionnaires will be obtained at each follow-up visit.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 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 Knees
Study Start Date : June 2011
Primary Completion Date : May 2012
Study Completion Date : August 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Ulthera® treatment of the knees
Bilateral treatment of the knees using the Ulthera® System
Device: Ulthera® System
Focused ultrasound energy delivered below the surface of the skin
Other Name: Ultherapy™ treatment

Primary Outcome Measures :
  1. Improvement in overall lifting and tightening of knee skin laxity. [ Time Frame: 90 and 180 days post-treatment ]
    Assessed based on Principal Investigator assessment using the Global Aesthetic Improvement Scale.

Secondary Outcome Measures :
  1. Overall improvement in skin laxity. [ Time Frame: 90 and 180 days post-treatment ]
    Determined based on a qualitative masked assessment comparing pre-treatment and post-treatment photographs; subjects' assessment based on the Subject Global Aesthetic Improvement Scale; completion of the Patient Satisfaction Questionnaire.

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:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Female, aged 30 to 65 years.
  • Subject in good health.
  • Mild to moderate skin laxity around the knees.
  • Understands and accepts the obligation not to undergo any other procedures in the areas to be treated through the follow-up period.

Exclusion Criteria:

  • Presence of an active systemic or local skin disease that may affect wound healing.
  • Excessive subcutaneous fat around the knees.
  • Excessive skin laxity around the knees.

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): NCT01708434

United States, Tennessee
Tennessee Clinical Research Center
Nashville, Tennessee, United States, 37215
Sponsors and Collaborators
Ulthera, Inc
Principal Investigator: Michael Gold, MD Tennessee Clinical Research Center

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ulthera, Inc
ClinicalTrials.gov Identifier: NCT01708434     History of Changes
Other Study ID Numbers: ULT-115
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 ):
Skin laxity

Additional relevant MeSH terms:
Cutis Laxa
Skin Diseases, Genetic
Genetic Diseases, Inborn
Connective Tissue Diseases
Skin Diseases