CompletedNot Applicable

Reducing Wrinkles Around the Eyes Using the Ulthera® System

United States68 participantsStarted 2011-03

Plain-language summary

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.

Who can participate

Age range30 Years – 65 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

What they're measuring

Overall Improvement in Periorbital Wrinkles and Rhytids Around the Eyes

Timeframe: 90 days post-treatment

Trial details

NCT IDNCT01368900

SponsorUlthera, Inc

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2011-10

Results submitted2013-04-17

View on ClinicalTrials.gov More Periorbital Wrinkles trials