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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00747422
Recruitment Status : Completed
First Posted : September 5, 2008
Last Update Posted : November 24, 2017
Information provided by (Responsible Party):
Merz North America, Inc. ( Ulthera, Inc )

Brief Summary:
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 or disease Intervention/treatment Phase
Periorbital Wrinkles Device: Ulthera™ System Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Evaluation of the Effectiveness and Safety of the Ulthera™ System for the Treatment of Periorbital Wrinkles
Study Start Date : July 2008
Actual Primary Completion Date : December 2008
Actual Study Completion Date : May 2009

Arm Intervention/treatment
Experimental: I Device: Ulthera™ System
ultrasound treatment

Primary Outcome Measures :
  1. reduction of periorbital wrinkles [ Time Frame: 3 and 6 months ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00747422

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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
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Responsible Party: Ulthera, Inc Identifier: NCT00747422    
Other Study ID Numbers: ULT-102
First Posted: September 5, 2008    Key Record Dates
Last Update Posted: November 24, 2017
Last Verified: October 2012