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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01708434

Enrollment

Registered

2012-10-17

Start date

2011-06-30

Completion date

2012-08-31

Last updated

2017-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Skin Laxity

Keywords

Skin laxity, Knees

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.

Interventions

DEVICEUlthera® System

Focused ultrasound energy delivered below the surface of the skin

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

30 Years to 65 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026