Ulthera® System for the Treatment of Moderate to Severe Facial Acne

• Change from baseline in facial acne [ Time Frame: 60 days post-treatment ] [ Designated as safety issue: No ]
  Determined by a reduction in inflammatory and non-inflammatory lesion counts from baseline.
  
  

• Change from baseline in skin clarity [ Time Frame: 180 days post-treatment ] [ Designated as safety issue: No ]
  Measured using a digital imaging system comparing baseline and post-treatment images.
  
  
• Reduction of sebum production [ Time Frame: 180 days post-treatment ] [ Designated as safety issue: No ]
  Assessments using a sebumeter will be performed comparing pre-treatment and post-treatment assessments.
  
  
• Patient Satisfaction at 60 days [ Time Frame: 60 day post-treatment ] [ Designated as safety issue: No ]
  Patient satisfaction as determined by completion of a patient satisfaction questionnaire.
  
  
• Patient Satisfaction at 180 days [ Time Frame: 180 Days post-treatment ] [ Designated as safety issue: No ]
  Patient satisfaction as determined by completion of patient satisfaction questionnaire.
  
  

Study subjects will be assigned to one of two treatment groups. Both treatment groups will receive treatment in the center of the forehead/temples, medial cheeks, and chin regions using the 1.5mm and 1.0mm transducers.

• For Group A, both the 1.5mm and 1.0mm transducers will be used at 0.25J energy setting and 0.20J energy setting, respectively.
• For Group B, both the 1.5mm and 1.0mm transducers will be used at 0.18J energy setting and 0.15J energy setting, respectively.

Subjects will receive 3 Ultherapy treatments administered 2 weeks apart. Subjects will be required to return for follow-up assessments at 14, 30, 60, 90 and 180 days following the third Ultherapy treatment. Pre- and post-treatment photos will be taken. In addition, pre- and post-treatment lesion counts and sebum measurements will be obtained.