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NCT Number: NCT01708434

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

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.

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Key information

Conditions

Skin Laxity Congenital, Hereditary, and Neonatal Diseases and Abnormalities Connective Tissue Diseases Cutis Laxa Genetic Diseases, Inborn Skin Diseases Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

30 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Tennessee Clinical Research Center

Nashville, Tennessee, 37215, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ulthera® System

Device

Focused ultrasound energy delivered below the surface of the skin

Other names: Ultherapy™ treatment

Primary outcomes

  1. 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

  1. Overall improvement in skin laxity.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Ulthera, Inc

Industry

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Oct 17, 2012
Registry last updated
Nov 24, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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