Feasibility Study: Higher Density Ulthera® System Treatment With Vectoring for Treatment of the Face and Neck

Completed · Not applicable

Conditions studied: Skin Laxity

In brief

All enrolled subject will receive one Ultherapy™ treatment. Study images will be obtained pre-treatment, immediate post-treatment, and at each study follow-up visit. Enrolled subjects will return for follow-up visits at 90 days, 180 days and 365 days post-treatment.

Key facts

Study ID

NCT01708512

Run by

Ulthera, Inc

People needed

21

Starts

2012-04-01

Expected to finish

2013-07-01

Last updated by the study team

2017-11-24

Who can join

Age: 25 and older, up to 60. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Male or female, aged 25 to 60 years.
• Subject in good health.
• Skin laxity in the area(s) to be treated.
• Understands and accepts the obligation not to undergo any other procedures in the area(s) to be treated through the follow-up 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.

You may not qualify if…

• Presence of an active systemic or local skin disease that may affect wound healing.
• Severe solar elastosis.
• Excessive subcutaneous fat in the area(s) to be treated.
• Excessive skin laxity on the area(s) to be treated.
• Significant scarring in area(s) to be treated.
• Open wounds or lesions in the area(s) to be treated.
• Severe or cystic acne on the area(s) to be treated.
• Presence of a metal stent or implant in the area(s) to be treated.
• Inability to understand the protocol or to give informed consent.
• BMI equal to and greater than 30.

Where it is running

• Premier Clinical Research — Spokane, Washington, United States

Full record on ClinicalTrials.gov

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