Feasibility Study: 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: June 27, 2013
Last verified: June 2013
  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: Feasibility Study: Evaluation of the Ulthera® System for Lifting and Tightening of the Knees

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 by Ulthera, Inc

Additional 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
Study First Received: October 15, 2012
Last Updated: June 27, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Ulthera, Inc:
Skin laxity
Knees

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

ClinicalTrials.gov processed this record on October 29, 2014