Feasibility Study: Evaluation of the Ulthera® System for Lifting and Tightening of the Knees
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Skin Laxity
- Sponsor
- Ulthera, Inc
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Improvement in overall lifting and tightening of knee skin laxity.
- Status
- Completed
- Last Updated
- 8 years ago
Overview
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.
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.
Investigators
Eligibility 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.
Outcomes
Primary Outcomes
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 Outcomes
- Overall improvement in skin laxity.(90 and 180 days post-treatment)