Reducing Wrinkles Around the Eyes Using the Ulthera® System

Completed · Not applicable

Conditions studied: Periorbital Wrinkles

In brief

The purpose of this prospective, multi-center, single treatment study is to evaluate the clinical outcomes associated with the non-invasive treatment to reduce wrinkles around the eyes utilizing the Ulthera® System to deliver focused ultrasound energy below the surface of the skin.

Key facts

Study ID

NCT01368900

Run by

Ulthera, Inc

People needed

68

Starts

2011-03-01

Expected to finish

2012-01-01

Last updated by the study team

2017-12-13

Who can join

Age: 30 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Male or female, aged 30 to 65 years.
• Subject in good health.
• Mild to moderate rhytids in the periorbital region.
• Willingness and ability to comply with protocol requirements and return for follow-up visits.
• Not pregnant.
• Provide written informed consent and HIPAA authorization.

You may not qualify if…

• Presence of an active systemic or local skin disease that may affect wound healing.
• Severe solar elastosis.
• Excessive subcutaneous fat in the face.
• Deep wrinkles, numerous lines, with or without redundant skin in the area to be treated.
• Excessive hooding, with or without redundant skin, in the areas to be treated.
• Significant scarring in areas to be treated.
• Significant open facial wounds or lesions.
• Severe or cystic acne on the face.
• Presence of a metal stent or implant in the facial area to be treated.

Where it is running

• MD Laser Skin & Vein Institute — Hunt Valley, Maryland, United States
• The Nashville Centre for Laser and Facial Surgery — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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