Energy-Based Lower Eyelid Rejuvenation - Proof of Concept for InMode AccuTite With or Without Morpheus8

Study Overview
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Brief Summary
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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). 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)

Detailed Description
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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). 15 patients will receive AccuTite treatment only (7-8 patients per arm at each of the two study sites) 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

Official Title
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Energy-Based Lower Eyelid Rejuvenation - Proof of Concept for InMode AccuTite With or Without Morpheus8

Conditions
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Periorbital Edema

Intervention / Treatment
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* Device: AccuTite
* Device: AccuTite + Morpheus 8


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult females and males between the ages of 29-75 inclusive, having minimum level 1 for convexity for both lower eyelids. The patients should understand the information provided about the investigative nature of the treatment, possible benefits, and side effects, and sign the Informed Consent Form, (including the permission to use photography). The patients should be willing to comply with the study procedure and schedule, including the follow-up visit, and will refrain from using any other aesthetic treatment methods for the last 6 months and during the entire study period. Exclusion Criteria: - Grade 3 lower eyelid convexity Grade 3 festoonage Prior lower eyelid fat removal (transconjunctival, transcutaneous) Prior lower eyelid skin resection Full-field or fractional laser skin resurfacing of lower eyelids in the past 24 months Tear trough, suborbital, midface filler injections in the past 24 months Neuromodulator treatment of crow's feet area in the past 12 months Lower eyelid malposition (rounding, retraction, ectropion, laxity) Meige syndrome Significant negative vector lower eyelid Pacemaker or internal defibrillator, or any other active electrical implant anywhere in the body. The Handpiece should be used at least 1cm away from cochlear implants in the ear. Superficial permanent implant in the treated area such as metal plates and screws, metal piercing, silicone implants or an injected chemical substance. Current or history of skin cancer (remission of 5 years), or current condition of any other type of cancer, or pre-malignant moles. Severe concurrent conditions, such as cardiac disorders, epilepsy, uncontrolled hypertension, and liver or kidney diseases. Pregnancy and nursing. History of bleeding coagulopathies or the use of anticoagulants. Impaired immune system due to immunosuppressive diseases such as AIDS and HIV or use of immunosuppressive medications. Poorly controlled endocrine disorders, such as diabetes or thyroid dysfunction and hormonal virilization. Any active condition in the treatment area, such as sores, psoriasis, eczema, and rash. History of skin disorders, keloids, abnormal wound healing, as well as very dry and fragile skin. Use of Isotretinoin (Accutane®) within 6 months prior to treatment. Any surgery or treatment such as laser or chemicals in the treated area within 3-6 months prior to treatment or before complete healing. Allergies, in particular to anesthesia. Mental disorders such as Body Dysmorphic Disorder (BDD). Monovision (single seeing eye) Corneal transplant Severe dry eyes As per the practitioner's discretion, refrain from treating any condition that might make it unsafe for the patient.

Ages Eligible for Study
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Minimum Age: 29 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: AccuTite<br>15 patients will receive AccuTite treatment only | Device: AccuTite<br>* Subjects will undergo treatment with AccuTite<br>|
| Active Comparator: AccuTite & Morpheus 8 Arm<br>15 patients will receive AccuTite and Morpheus8 treatment and additional 2 monthly Morpheus8 treatments | Device: AccuTite + Morpheus 8<br>* Subjects will undergo treatment with AccuTite and Morpheus 8<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 = mild convexity lower eyelid = moderate convexity lower eyelid = severe convexity 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 = single skin fold at or below inferior orbital rim = double skin fold at or below inferior orbital rim = triple 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 |