The Genius system is substantially equivalent to the Infini device (K121481). The study is a prospective, multi-site, non-randomized study of up to 30 treated subjects presenting for treatment of mild to moderate lines, wrinkles, textural concerns, and/or skin laxity of the neck.
At enrollment, standardized baseline/pretreatment 2D and 3D images will be obtained from each subject. Study subjects will receive three neck treatments completed 30 days apart. Subjects will be contacted via a phone call 3 days following each treatment to assess for adverse events and expected treatment effects. Effectiveness assessments will occur prior to Treatments #2 and #3, and a follow-up visit will be completed at 90 days following Treatment #3. Each assessment visit will include efficacy, adverse events, and expected treatment effects assessments, and post-treatment 2D and 3D digital images will be captured.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
18
Treatment of the neck using the Lutronic Genius System
Laser and Skin Surgery Center of New York
New York, New York, United States
Masked qualitative assessment of improvement
An assessment of paired pre- and post-treatment photographs will be conducted by blinded assessors evaluating for improvement in neck appearance from pre- to post-treatment. The assessors choose the photo they believe to be the post-treatment photo, i.e., Left photo or Right photo.
Time frame: From baseline to 90 days following the last treatment
Clinician aesthetic improvement
Overall aesthetic improvement based on completion of the Clinician Global Aesthetic Improvement Scale, a 5-point scale (0-4) that rates global aesthetic improvement from the pre-treatment appearance with 4 being 'Very Much Improved' and 0 being 'Worse'. The scale will be administered 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 the Day 90 follow-up photographs.
Time frame: From baseline to Days 90 following the last study treatment.
Subject aesthetic improvement
Overall aesthetic improvement based on completion of the Subject Global Aesthetic Improvement Scale, a 5-point scale (0-4) that rates global aesthetic improvement from the pre-treatment appearance with 4 being 'Very Much Improved' and 0 being 'Worse'. Subjects will complete the scale based on a live assessment while referring to a hand mirror and their pre-treatment photographs, and based on a comparison of their pre-treatment photographs to their Day 90 follow-up photographs.
Time frame: From baseline to Days 90 following the last study treatment.
Patient Satisfaction
Patient satisfaction will be evaluated based on subjects' completion of a patient satisfaction questionnaire while referring to a hand mirror and their pre-treatment and their Day 90 follow-up photographs.
Time frame: From baseline to 90 days following the last study treatment
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Treatment-related pain
During each study treatment, subjects' pain levels will be monitored using a validated Numeric Rating Scale (0-10), with 0 being 'No Pain' and 10 being 'Worse Possible Pain'.
Time frame: For the duration of each study treatment which typically can last up to approximately 90 minutes.