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

Ulthera

Status: Completed

Conditions: Periorbital Wrinkles

Treatments: Device: Ulthera™ System

Study type: Interventional

Funder types: Industry

Identifiers

NCT00747422

ULT-102

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 40 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

I

Experimental group

Treatment:

Device: Ulthera™ System