The purpose of this study is to evaluate the ability of the Serene RF System to effectively improve the appearance of dynamic glabellar lines and sustain the effect for a minimum of 3 months.
Study Type
OBSERVATIONAL
Enrollment
78
The Serene RF System provides percutaneous delivery of radiofrequency (RF) energy to a targeted nerve.
Premier Plastic Surgery
Palo Alto, California, United States
Premier Plastic Surgery
San Mateo, California, United States
Aesthetic Plastic Surgery
New York, New York, United States
Reviance Plastic Surgery & Aesthetics Center
Clackamas, Oregon, United States
The reduction of glabellar lines
The reduction of glabellar lines will be assessed by a panel of 3 independent reviewers with expertise in dermatology and/or plastic surgery of the change in glabellar lines measured from baseline to 3, 6, 9 and 12 months post procedure. Photographs will be presented in a random order and the reviewers will be blinded to whether the photograph is baseline or a follow up. Effectiveness of the procedure is defined by a ≥ 1 point improvement in score (i.e., numerical decrease) on the Mertz Aesthetics Scale™ (Merz Scale) for dynamic glabellar lines. At each time point the severity of the glabellar lines is assessed on a 5 point scale.
Time frame: 3 months
Incidence and severity of adverse events
Time frame: 3 months
The reduction of glabellar lines
The reduction of glabellar lines will be assessed by a panel of 3 independent reviewers with expertise in dermatology and/or plastic surgery of the change in glabellar lines measured from baseline to 3, 6, 9 and 12 months post procedure. Photographs will be presented in a random order and the reviewers will be blinded to whether the photograph is baseline or a follow up. Effectiveness of the procedure is defined by a ≥ 1 point improvement in score (i.e., numerical decrease) on the Mertz Aesthetics Scale™ (Merz Scale) for dynamic glabellar lines. At each time point the severity of the glabellar lines is assessed on a 5 point scale.
Time frame: 12 months
Subject satisfaction
Subject satisfaction will be assessed by a survey given every 3 months. This survey asks the subject questions to rate on a scale of 0-4 with 0 representing very dissatisfied and 4 representing very satisfied.
Time frame: 12 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Puget Sound Plastic Surgery
Kirkland, Washington, United States