Lifting and Tightening of the Face and Neck Following an Increased Density Treatment



Status:Completed
Conditions:Dermatology
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:30 - 65
Updated:12/13/2017
Start Date:August 2011
End Date:March 2013

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Evaluation of the Efficacy and Safety of the Ulthera® System for Lifting and Tightening of the Face and Neck Following an Increased Density Treatment.

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 when increased density treatment is applied.

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, 90 days, 180 days and 1 year following treatment.

Inclusion Criteria:

- 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 Criteria:

- 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
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