Status:
COMPLETED
Lifting and Tightening of the Face and Neck Following an Increased Density Treatment
Lead Sponsor:
Ulthera, Inc
Conditions:
Skin Laxity
Eligibility:
All Genders
30-65 years
Phase:
NA
Brief Summary
The purpose of this study is to evaluate the Ulthera® System for obtaining lift and tightening of the cheek tissue, reduction of jowling, and improving jawline definition and/or submental skin laxity ...
Detailed Description
All enrolled study subjects will receive one full face and neck Ultherapy™ treatment. Pre- and post-treatment photos will be taken. Subjects will be required to return for follow-up visits at 60 days,...
Eligibility Criteria
Inclusion
- Male or female, aged 30 to 65 years
- Subject in good health
- Desires lift and tightening of cheek tissue, reduction of jowling, improvement of jawline definition and/or submental skin laxity
- Understands and accepts the obligation not to undergo any other procedures in the areas to be treated through the followup period
- Willingness and ability to comply with protocol requirements, including returning for follow-up visits and abstaining from exclusionary procedures for the duration of the study
Exclusion
- Presence of an active systemic or local skin disease that may affect wound healing
- Severe solar elastosis
- Excessive subcutaneous fat on the cheeks
- Excessive skin laxity on the lower face and neck
- 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, a pacemaker, or cochlear implants
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2013
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT01519206
Start Date
August 1 2011
End Date
March 1 2013
Last Update
December 11 2017
Active Locations (1)
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1
Laser & Skin Surgery Center of NY
New York, New York, United States, 10016