To evaluate the Ulthera® System for lifting submental (under the chin) and neck tissue in Chinese patients
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
All subjects will receive an Ultherapy® treatment at dual depth using the 4-4.5mm and 7-3.0mm transducers. Treatments will be provided to the lower face, submental (under the chin) and neck area.
Merz Investigational Site # 0010411
Los Gatos, California, United States
Merz Investigational Site # 0010321
San Diego, California, United States
Merz Investigational Site # 0010358
Vista, California, United States
Merz Investigational Site # 0010410
Austin, Texas, United States
Mean Change From Baseline in Overall Lifting and Tightening of Submental (Under the Chin) and Neck Tissue Area at Day 90 Post-treatment
Lifting was determined by a quantitative measure of tissue lift in the area using photographs taken with Mirror Photofile software and a Vectra 3 dimensional (3D) digital imaging system. Mean change was calculated as mean of left and right side 90 day area minus mean of left and right baseline area.
Time frame: Baseline and Day 90
Number of Participants With Improvement From Baseline in Overall Lifting and Tightening of Submental (Under the Chin) and Neck Tissue Area as Assessed by Physician Global Aesthetic Improvement Scale (PGAIS) Scores at Day 90 Post-treatment
Overall aesthetic improvement was assessed by a principal investigator using global aesthetic improvement scale (GAIS).The PGAIS was a 5-point scale (-2 to 2) that rates global aesthetic improvement from the pre-treatment appearance in which live observation and photo review were utilized by the physician. The ratings are -2 (much worse), -1 (worse), 0 (no change), 1 (improved), and 2 (much improved). Improvement was determined by participant response rate (improved or much improved) on PGAIS.
Time frame: Day 90
Number of Participants With Improvement From Baseline in Overall Lifting and Tightening of Submental (Under the Chin) and Neck Tissue Area as Assessed by Subject Global Aesthetic Improvement Scale (SGAIS) at Day 90 Post-treatment
Overall aesthetic improvement was assessed by a principal investigator using GAIS. The SGAIS was a 5-point scale (-2 to 2) that rates global aesthetic improvement from the pre-treatment appearance in which live observation and photo review were utilized by the participant. The ratings are -2 (much worse), -1 (worse), 0 (no change), 1 (improved), and 2 (much improved). Improvement is determined by participant response rate (improved or much improved) on SGAIS.
Time frame: Day 90
Number of Participants With Improvement From Baseline in Overall Lifting and Tightening of Submental (Under the Chin) and Neck Tissue Area as Assessed by a Masked, Qualitative Assessment of Photographs at Day 90 Post-treatment
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Merz Investigational Site # 0010422
Bellaire, Texas, United States
Merz Investigational Site # 0010423
Houston, Texas, United States
Merz Investigational Site # 0010125
Plano, Texas, United States
Masked, qualitative photographic assessment of photographs were obtained using Mirror Photofile software and a Vectra 3D digital imaging system. Experienced physicians evaluated paired pre- and 90-days post-treatment photographs of evaluable participants in a blinded fashion. Each blinded assessor reviewed the image sets and identified the post-treatment photographs according to the following definitions: Change (A change that is noticeable) and No Change (No change is apparent). Blinded assessors were asked to compare pre- and post-treatment photos for noticeable change. When change was noted the assessors were asked to determine which image demonstrated improvement. Assessor data were compiled and analyzed using majority rule for each participant assessed.
Time frame: Day 90
Number of Participants With Satisfaction Responses as Assessed by Patient Satisfaction Questionnaire (PSQ) at Day 90 Post-treatment
Participant satisfaction was determined by scores on PSQ completed at 90 days post-treatment. The participant completed this assessment while referring to baseline photos on a sponsor-supplied electronic tablet and a hand mirror. Participants were requested to provide information on "Please indicate what you think about how the treated areas of your lower face and neck look today. With your face relaxed (do not smile), look in the mirror at the treated area on both sides of your face and compare to the photos taken of both sides of your face prior to your study treatment." First questionnaire was as "Compared to when you started the study, how do your lower face, under your chin, and your upper neck look today?" Improved (much improved, improved, little improved), no change, worse. Second questionnaire was "How would you characterize your satisfaction with the treatment?" Satisfied (extremely satisfied, satisfied, slightly satisfied), neither satisfied or dissatisfied, dissatisfied.
Time frame: Day 90