Status:
COMPLETED
Evaluation of the Effectiveness and Safety of the Ulthera™ System for the Treatment of Wrinkles Around the Eyes
Lead Sponsor:
Ulthera, Inc
Conditions:
Periorbital Wrinkles
Eligibility:
All Genders
40-70 years
Phase:
NA
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 wrinkle...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2009
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00747422
Start Date
July 1 2008
End Date
May 1 2009
Last Update
November 24 2017
Active Locations (4)
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1
Scripps Clinic Carmel Valley, Division of Laser and Cosmetic Dermatology
San Diego, California, United States, 92130
2
Northwestern University Department of Dermatology
Chicago, Illinois, United States, 60611
3
SkinCare Physicians
Chestnut Hill, Massachusetts, United States, 02467
4
Zel Skin and Laser Specialists
Edina, Minnesota, United States, 55424