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

Completed · Not applicable

Conditions studied: Periorbital Wrinkles

In brief

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.

Key facts

Study ID

NCT00747422

Run by

Ulthera, Inc

People needed

100

Starts

2008-07-01

Expected to finish

2009-05-01

Last updated by the study team

2017-11-24

Who can join

Age: 40 and older, up to 70. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Scripps Clinic Carmel Valley, Division of Laser and Cosmetic Dermatology — San Diego, California, United States
• Northwestern University Department of Dermatology — Chicago, Illinois, United States
• SkinCare Physicians — Chestnut Hill, Massachusetts, United States
• Zel Skin and Laser Specialists — Edina, Minnesota, United States

Full record on ClinicalTrials.gov

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