Up to 25 subjects will be enrolled. Enrolled subjects will received on Ulthera® treatment on one half of their surgical scar. Follow up visits will occur at 30, 90 and 180 days after treatment. Study images will be obtained before treatment, immediately after treatment and at each follow-up visit.
This is a prospective, single-center, pilot clinical trial to evaluate the efficacy of the Ulthera® system to improve the appearance of scar tissue on the neck, abdomen or back. Changes from baseline of the Patient Observer Scar Assessment Scale score will be assessed at study follow-up visits. Images will be obtained prior to treatment and at each follow up visit. Patient satisfaction questionnaires will also be obtained.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
14
All subjects will receive an Ultherapy™ treatment at triple depth using the 4-4.5mm, 7- 3.0mm, 10-1.5mm transducers on one half of the scar and no treatment on the other half of the scar. Treatments will be provided to the defined scar area, treating with a density of lines that is equivalent to 30 lines per transducer per 2.5cm in scar length for a total of 90 lines in a 2.5cm X 2.5cm square area.
MGH Dermatology Laser and Cosmetic Center
Boston, Massachusetts, United States
The primary endpoint is improvement in appearance of scar tissue as determined by a masked, qualitative assessment of photographs at 90-days post-treatment time points comparing the treated to untreated side of the scar.
Masked assessors will compare baseline images to images obtained at the 90 day follow up time point in a blinded fashion.
Time frame: 90 days
1. Improvement in POSAS score of the treated half of the scar as assessed by the observer using the Patient and Observer Scar Assessment Scale (POSAS) at 90-days post-treatment compared to baseline.
The observer will complete the Patient and Observer Scar Assessment Scale (6 questions) prior to treatment and at each follow up visit on both halves of the scar (treated and untreated). Scores will be tabulated and compared for improvement at 90 days after treatment.
Time frame: 90 Days
2. Difference in POSAS score as assessed by the patient using the Patient Observer Scar Assessment Scale (POSAS) between the treated and untreated half of the scar at 90-days post-treatment compared to baseline.
The subject will complete the Patient and Observer Scar Assessment Scale (6 questions) prior to treatment and at each follow up visit on both halves of the scar (treated and untreated). Scores will be tabulated and compared for improvement at 90 days after treatment.
Time frame: 90 Days
3. Patient satisfaction questionnaire at the 90-day follow-up visit.
Each subject will complete a Patient Satisfaction Questionnaire (PSQ) at the 90 follow-up visit. These results will be tabulated to assess subjects satisfaction with the treatment.
Time frame: 90 Days
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