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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AccuTite | Active Comparator | 15 patients will receive AccuTite treatment only |
|
| AccuTite & Morpheus 8 Arm | Active Comparator | 15 patients will receive AccuTite and Morpheus8 treatment and additional 2 monthly Morpheus8 treatments |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AccuTite | Device | Subjects will undergo treatment with AccuTite |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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
| 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
| 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 | Change from baseline at 3 and 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Holcomb, MD | Holcomb Kreithen Plastic Surgery and MedSpa | Principal Investigator |
| Richard Gentile, MD | Gentile Facial Plastic and Aesthetic Laser Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| David Holcomb | Sarasota | Florida | 34237 | United States | ||
| Gentile Facial Plastic and Aesthetic Laser Center |
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| ID | Term |
|---|---|
| D054517 | Orbital Cellulitis |
| ID | Term |
|---|---|
| D009916 | Orbital Diseases |
| D005128 | Eye Diseases |
| D002481 | Cellulitis |
| D003240 | Connective Tissue Diseases |
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| AccuTite + Morpheus 8 |
| Device |
Subjects will undergo treatment with AccuTite and Morpheus 8 |
|
| Youngstown |
| Ohio |
| 44512 |
| United States |
| D017437 |
| Skin and Connective Tissue Diseases |