NCT01591304

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

Feasibility Study: Evaluation of the Safety and Effectiveness of the Ulthera® System for the Treatment of Moderate to Severe Facial Acne

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Ulthera, Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the effectiveness of Ultherapy for the treatment of facial acne.

Detailed description

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.

Conditions

• Facial Acne

Interventions

Type	Name	Description
DEVICE	Ulthera System Treatment	Focused ultrasound energy delivered below the surface of the skin.

Timeline

• Start date: 2011-08-01
• Primary completion: 2014-06-01
• Completion: 2014-07-01
• First posted: 2012-05-03
• Last updated: 2017-11-24

Locations

2 sites across 1 country: United States