Periorbital Wrinkles
Conditions
Brief summary
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.
Detailed 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.
Interventions
DEVICEUlthera™ System
ultrasound treatment
Sponsors
Ulthera, Inc
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 70 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| reduction of periorbital wrinkles | 3 and 6 months |
Countries
United States
Outcome results
None listed