1. To establish clinical efficacy, safety and patient satisfaction of reducing lower eyelid convexities or "bags" and/or malar crescents (festoons) with catheter-based injectable RF (InMode AccuTite) and variable depth Fractional RF Microneedle skin rejuvenation (InMode Morpheus8). 2. To determine the relative effectiveness of dual-modality treatment (AccuTite + Morphues8 initial treatment followed by two consecutive Morpheus8 treatments 1 month apart) versus single modality treatment (AccuTite only)
This prospective study is intended to evaluate the efficacy of radio frequency energy in reducing lower eyelid convexities or "bags" and/or malar crescents (festoons) with RFAL (InMode AccuTite) and variable depth Fractional RF resurfacing skin rejuvenation (InMode Morpheus8). 1. 15 patients will receive AccuTite treatment only (7-8 patients per arm at each of the two study sites) 2. 15 patients will receive AccuTite and Morpheus8 treatment and additional 2 monthly Morpheus8 treatments (7-8 patients per arm at each of the two study sites) Treatment areas include: periorbital zones with Morpheus8/Lower Eyelid with Accutite
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
12
Subjects will undergo treatment with AccuTite
Subjects will undergo treatment with AccuTite and Morpheus 8
David Holcomb
Sarasota, Florida, United States
Gentile Facial Plastic and Aesthetic Laser Center
Youngstown, Ohio, United States
Correct identification at baseline and post treatment pictures
Correct identification of the 3 and 6 Months post last treatment photographs from the baseline by at least two of the three blinded reviewers in 75% of the subjects.
Time frame: Change from baseline at 3 and 6 months
Change in lower eyelid convexity scale
Investigator assessment of the Lower eyelid convexity scale (based on right and left lateral photography assessments with Canfield Scientific imaging) at 3 and 6 months follow up visit and compared to the baseline, as follows: 0 = flat lower eyelid 1. = mild convexity lower eyelid 2. = moderate convexity lower eyelid 3. = severe convexity lower eyelid
Time frame: Change from baseline at 3 and 6 months
Change in Festoonage scale
Investigator assessment of the Festoonage scale (based on photography assessments with Canfield Scientific imaging TBD) at 3 and 6 months follow up visit and compared to the baseline, as follows: 0 = no skin fold at or below inferior orbital rim 1. = single skin fold at or below inferior orbital rim 2. = double skin fold at or below inferior orbital rim 3. = triple skin fold at or below inferior orbital rim
Time frame: Change from baseline at 3 and 6 months
Subject assessment of satisfaction
Subject assessment of satisfaction will be filled out by subjects using a 5-points Likert scale at 3 and 6 months follow up, as follows: +2 = Very satisfied; +1 = Satisfied; 0 = Indifferent; -1 = Disappointed; -2 = Very disappointed
Time frame: Change from baseline at 3 and 6 months
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