This is prospective, multi-center clinical trial. Enrolled subjects will receive one Ulthera® treatment on the decolletage. Follow-up visits will occur at 90 and 180 days following treatment. Study images will be obtained pre-treatment, immediately post-treatment, and at each follow-up visit.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
SINGLE
Enrollment
129
Focused ultrasound energy delivered below the surface of the skin
Laser Skin and Surgery Center of Northern California
Sacramento, California, United States
Dermatology Cosmetic Laser Medical Associates of La Jolla, Inc.
San Diego, California, United States
Denova Research
Chicago, Illinois, United States
Tennessee Research Center
Nashville, Tennessee, United States
Percentage of Participants With a Reduction in Chest Wrinkles at 90 Days Post Treatment
Assessment of improvement, in a blinded fashion, using a Chest Wrinkle Scale at 90 days post-treatment. However, during conduct of the trial, the Chest Wrinkle scale was deemed inadequate as a primary endpoint in this study. Therefore, conduct of a traditional blinded masked assessment, the gold-standard measure in aesthetics, was used as the primary endpoint,i.e., improvement in wrinkles and lines of the décolletage as determined by a blinded, masked, qualitative assessment of photographs at 90 days post-treatment compared to baseline. "Improvement" = a blinded evaluator assessed an "Improvement" when evaluating a masked, paired photo set and correctly chose the Post treatment photo. "Incorrect" = a blinded evaluator assessed an "Improvement" when evaluating a masked, paired photo set but incorrectly chose the Post treatment photo.
Time frame: 90 Days post-treatment
Percentage of Participants With a Reduction in Chest Wrinkles at 180 Days Post Treatment
Assessment of improvement, in a blinded fashion, using a Chest Wrinkle Scale at 180 days post-treatment. However, during conduct of the trial, the Chest Wrinkle scale was deemed inadequate as a primary endpoint in this study. Therefore, conduct of a traditional blinded masked assessment, the gold-standard measure in aesthetics, was used as the primary endpoint, improvement in wrinkles and lines of the décolletage as determined by a blinded, masked, qualitative assessment of photographs at 180 days .post-treatment compared to baseline. "Improvement" = a blinded evaluator assessed an "Improvement" when evaluating a masked, paired photo set and correctly chose the Post treatment photo. "Incorrect" = a blinded evaluator assessed an "Improvement" when evaluating a masked, paired photo set but incorrectly chose the Post treatment photo.
Time frame: 180 days post treatment
Overall Aesthetic Improvement at 90 Days Post-treatment
The overall level of aesthetic improvement at 90 Days post treatment compared to baseline was assessed using a Clinician Global Aesthetic Improvement Scale (CGAIS). The CGAIS is a 5-point scale with the following descriptors: 1. Very much improved 2. Much improved 3. Improved 4. No change 5. Worse The scale was completed in two steps: * Based on a live assessment of the subject while referring to the subject's pre-treatment photographs; and * Based on a comparison of the subject's pre-treatment photographs to current post-treatment photographs. "Improved" = Very Much Improved + Much Improved + Improved
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Time frame: 90 days post-treatment
Overall Aesthetic Improvement at 180 Days Post-treatment
The overall level of aesthetic improvement at 180 Days post treatment compared to baseline was assessed using a Clinician Global Aesthetic Improvement Scale (CGAIS). The CGAIS is a 5-point scale with the following descriptors: 1. Very much improved 2. Much improved 3. Improved 4. No change 5. Worse The scale was completed in two steps: * Based on a live assessment of the subject while referring to the subject's pre-treatment photographs; and * Based on a comparison of the subject's pre-treatment photographs to current post-treatment photographs. "Improved" = Very Much Improved + Much Improved + Improved
Time frame: 180 days post-treatment
Subject Satisfaction at 90 Days Post-treatment
Subject satisfaction was measured at 90 days post-treatment using a Patient Satisfaction Questionnaire (PSQ). A 5-point PSQ scale was used with the following descriptors: 1. Very Satisfied 2. Satisfied 3. Neither Satisfied or Dissatisfied 4. Dissatisfied 5. Very Dissatisfied "Satisfied"= Very Satisfied + Satisfied "Dissatisfied"=Dissatisfied + Very Dissatisfied
Time frame: 90 days post-treatment
Subject Satisfaction at 180 Days Post-treatment
Subject satisfaction was measured at 180 days post-treatment using a Patient Satisfaction Questionnaire (PSQ). A 5-point PSQ scale was used with the following descriptors: 1. Very Satisfied 2. Satisfied 3. Neither Satisfied or Dissatisfied 4. Dissatisfied 5. Very Dissatisfied "Satisfied" = Very Satisfied + Satisfied "Dissatisfied" = Dissatisfied + Very Dissatisfied
Time frame: 180 days post-treatment