Breast Augmentation Clinical Trial
Official title:
Clinical Evaluation of the Safety and Performance of Fractional RF for the Treatment of Surgical Scars Following Breast Augmentation, Abdominoplasty or Face Lift
Split-body/face evaluator-blind study of the safety and performance of fractional RF for the treatment of surgical scars following breast augmentation, abdominoplasty or face lift. The study will enroll up to 50 female subjects requesting treatment of surgical scars following breast augmentation or abdominoplasty and up to 25 male and female subjects requesting treatment of surgical scars following face lift surgery. Subjects will receive a total of three treatments of their surgical scars at one-month intervals on one side of the body or face only. Subjects will be followed up at one, two, three and ten months after their last treatment. Outcomes will be compared to the non-treated side.
Blinded evaluators to determine the efficacy of the study treatment by comparing baseline photographs with photographs taken at follow up months 3, 4, 5 and 12 using the Global Aesthetic Improvement scale (GAIS), Manchester Scar Scale (MSS) and Patient and Observer Scar assessment scale (POSAS). Study subjects will also complete a Patient and Observer Scar assessment scale (POSAS) and 5-Point Likert Satisfaction Scale at baseline and at follow-up month 5 and 12, indicating their satisfaction with the study treatment. ;
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