Evaluation of the Effectiveness and Safety of the Ulthera™ System for the Treatment of Wrinkles Around the Eyes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ulthera, Inc
ClinicalTrials.gov Identifier:
NCT00747422
First received: September 3, 2008
Last updated: October 15, 2012
Last verified: October 2012
  Purpose

The purpose of this study is to look at how safe and effective the Ulthera ultrasound system is at reducing the appearance of wrinkles when used with subjects who have wrinkles around the eyes.


Condition Intervention
Periorbital Wrinkles
Device: Ulthera™ System

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Evaluation of the Effectiveness and Safety of the Ulthera™ System for the Treatment of Periorbital Wrinkles

Further study details as provided by Ulthera, Inc:

Primary Outcome Measures:
  • reduction of periorbital wrinkles [ Time Frame: 3 and 6 months ] [ Designated as safety issue: Yes ]

Enrollment: 100
Study Start Date: July 2008
Study Completion Date: May 2009
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: I Device: Ulthera™ System
ultrasound treatment

Detailed Description:

The purpose of this prospective, multi-center, single treatment, clinical trial is to evaluate the effectiveness and safety of the Ulthera™ System for the non-invasive treatment of periorbital wrinkles and rhytids.

  Eligibility

Ages Eligible for Study:   40 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male or female, aged 40 to 70 years
  • Subject in good health
  • Desire improvement in periorbital wrinkles
  • Subject provides informed consent and agrees to attend follow-up visits
  • Subject signs a HIPPA authorization

Exclusion Criteria:

  • Pregnant or lactating
  • Has an active systemic or local skin disease that may alter wound healing
  • Has significant scarring in test areas
  • Has significant open facial wounds or lesions
  • Has severe or cystic acne on the face
  • Has a metal stent or implant in the face area
  • Is a current smoker or has a history of smoking in last 10 years
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00747422

Locations
United States, California
Scripps Clinic Carmel Valley, Division of Laser and Cosmetic Dermatology
San Diego, California, United States, 92130
United States, Illinois
Northwestern University Department of Dermatology
Chicago, Illinois, United States, 60611
United States, Massachusetts
SkinCare Physicians
Chestnut Hill, Massachusetts, United States, 02467
United States, Minnesota
Zel Skin and Laser Specialists
Edina, Minnesota, United States, 55424
Sponsors and Collaborators
Ulthera, Inc
  More Information

No publications provided

Responsible Party: Ulthera, Inc
ClinicalTrials.gov Identifier: NCT00747422     History of Changes
Other Study ID Numbers: ULT-102
Study First Received: September 3, 2008
Last Updated: October 15, 2012
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on August 18, 2014