Feasibility Study: Evaluation of the Ulthera® System for Treatment of Abdominal Tissue

Completed · Not applicable

Conditions studied: Skin Laxity, Skin Crepiness

In brief

Enrolled subjects will receive one UltherapyTM treatment on the abdomen. Follow-up visits will occur at 90 and 180 days post-treatment. Study images will be obtained pre-treatment, immediately post-treatment, and at each follow-up visit.

Key facts

Study ID

NCT01708499

Run by

Ulthera, Inc

People needed

24

Starts

2012-03-01

Expected to finish

2013-04-01

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 abdomen
• Understands and accepts the obligation not to undergo any other procedures in the areas 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 abdomen.
• Excessive skin laxity on the abdomen.
• Significant scarring in areas to be treated.
• Open wounds or lesions in the area to be treated.
• Inability to understand the protocol or to give informed consent.
• BMI equal to and greater than 30.

Where it is running

• Sasaki Advanced Aesthetic Medical Center — Pasadena, California, United States

Full record on ClinicalTrials.gov

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