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

Skin Laxity Clinical Trial

Official title:

Feasibility Study: Evaluation of the Ulthera® System for Lifting and Tightening of the Knees

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01708434
• Other study ID #: ULT-115
• Status: Completed
• Phase: N/A
• First received: October 15, 2012
• Last updated: November 21, 2017
• Start date: June 2011
• Est. completion date: August 2012

Study information

• Verified date: June 2013
• Source: Merz Pharmaceuticals, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 30 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cutis Laxa
• Skin Laxity

Intervention

Device:
• Ulthera® System
Focused ultrasound energy delivered below the surface of the skin

Locations

Country	Name	City	State
United States	Tennessee Clinical Research Center	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Ulthera, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement in overall lifting and tightening of knee skin laxity.	Assessed based on Principal Investigator assessment using the Global Aesthetic Improvement Scale.	90 and 180 days post-treatment
Secondary	Overall improvement in skin laxity.	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.	90 and 180 days post-treatment