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

Not Applicable

Completed

• Conditions: Skin Laxity
• Interventions: Device: Ulthera® System

• Registration Number: NCT01708434
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2011-06
• Primary Completion: 2012-05
• Study Completion: 2012-08
• Study First Submitted: 2012-10-15
• Study First Submitted QC: 2012-10-16
• Study First Posted: 2012-10-17
• Status Verified: 2013-06
• Last Update Submitted: 2017-11-21
• Last Update Posted: 2017-11-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ulthera® treatment of the knees	Ulthera® System	Bilateral treatment of the knees using the Ulthera® System

Primary Outcome Measures

Name	Time	Method
Improvement in overall lifting and tightening of knee skin laxity.	90 and 180 days post-treatment	Assessed based on Principal Investigator assessment using the Global Aesthetic Improvement Scale.

Secondary Outcome Measures

Name	Time	Method
Overall improvement in skin laxity.	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.

Trial Locations

Locations (1)

Tennessee Clinical Research Center; 🇺🇸 Nashville, Tennessee, United States