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Evaluation of the Ulthera® System for Treatment of the Knees

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ulthera, Inc
ClinicalTrials.gov Identifier:
NCT01708434
First received: October 15, 2012
Last updated: February 27, 2013
Last verified: February 2013
History of Changes
  Purpose

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 Intervention
Skin Laxity
 Device: Ulthera® System

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of the Ulthera® System for Lifting and Tightening of the Knees

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Ulthera, Inc:

Primary Outcome Measures:
  • Improvement in overall lifting and tightening of knee skin laxity. [ Time Frame: 90 and 180 days post-treatment ] [ Designated as safety issue: No ]
    Assessed based on Principal Investigator assessment using the Global Aesthetic Improvement Scale.


Secondary Outcome Measures:
  • Overall improvement in skin laxity. [ Time Frame: 90 and 180 days post-treatment ] [ Designated as safety issue: No ]
    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.


Enrollment: 30
Study Start Date: June 2011
Study Completion Date: August 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   30 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01708434

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

No publications provided

Responsible Party: Ulthera, Inc
ClinicalTrials.gov Identifier: NCT01708434     History of Changes
Other Study ID Numbers: ULT-115
Study First Received: October 15, 2012
Last Updated: February 27, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Ulthera, Inc:
Skin laxity
Knees

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

ClinicalTrials.gov processed this record on May 16, 2013