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.
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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
Device: Ulthera™ System
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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Ages Eligible for Study:
40 Years to 70 Years (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
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