Treatment of the Face and Neck With Lower Ulthera System Energy Settings

Comparador activo: Group A

Subjects will receive an increased density Ulthera System Treatment over the full face but with the energy turned down to the second highest level of four possible energy settings on one side of the face.

Dispositivo: Tratamiento del sistema Ulthera

Energía de ultrasonido enfocada entregada debajo de la superficie de la piel

Otros nombres:

• Ulterapia™

Comparador activo: Group B

Subjects will receive an increased density guideline Ulthera System Treatment over the full face but with the energy turned down to the lowest level of four possible energy settings on one side of the face.

Dispositivo: Tratamiento del sistema Ulthera

Energía de ultrasonido enfocada entregada debajo de la superficie de la piel

Otros nombres:

• Ulterapia™

Comparador activo: Group C

Subjects will receive an increased density guideline Ulthera System Treatment over the full face with the exception that a 4 MHz transducer will be used on the upper face in place of a7 MHz transducer, with the energy turned down to the lowest level of four possible energy settings.

Dispositivo: Tratamiento del sistema Ulthera

Energía de ultrasonido enfocada entregada debajo de la superficie de la piel

Otros nombres:

• Ulterapia™

Subjects' Assessment of Pain During Treatment With Lower Energy Settings

Subjects' sensory response to the Ulthera treatment exposures were recorded using a validated Numeric Rating Scale (NRS,0-10), for each anatomical region treated and energy settings used, with 0 representing no pain and 10 representing the worst pain possible.

Pain scores were collected in a consistent manner, following treatment of each section of the face and neck on both sides (submental, submandibular, cheek, periorbital, infraorbital, and forehead), and for each transducer used. Split-face comparisons of pain scores obtained during study treatment by research staff blinded to the energy settings used were completed.

Overall Improvement in Skin Laxity on the Face and Neck

A split-face comparison of improvement in overall lifting and tightening of skin was completed by three masked assessors. Pre-treatment and 90 days post-treatment photos from 45 subjects who returned for their 90-day follow-up visit were reviewed, assessing for improvement in skin laxity, i.e., lifted and tightened skin in the areas treated using treatment energy settings based on subjects' assigned study group.

Quantitative Assessment of Brow Lift at 90 Days Post-treatment

Quantitative assessment and analysis of brow lift from baseline to 90 days post-treatment was completed comparing brow lift achieved using standard energy settings compared to adjusted energy settings. The number of subjects with 1 mm or more brow lift is reported. Note: Because the submental region was treated using standard energy settings in all study groups, a quantitative analysis of lift in this region between the study groups would most likely not be informative, and therefore was not completed.

Subject Assessment of Improvement at 90 Days Post-treatment

Subjects completed a Patient Assessment Questionnaire at 90 days post-treatment by referring to their image in a mirror, their 90-day post-treatment photos, and their pre-treatment photos, and reporting if any improvement was noted on the right and left sides of their face and neck.

Subject Assessment of Improvement at 180 Days Post-treatment

Subjects completed a Patient Assessment Questionnaire at 180 days post-treatment by referring to their image in a mirror, their 180-day post-treatment photos, and their pre-treatment photos, and reporting if any improvement was noted on the right and left sides of their face and neck.