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

Completed · Not applicable

Conditions studied: Periorbital Edema

In brief

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)

Key facts

Study ID

NCT04103619

Run by

InMode MD Ltd.

People needed

12

Starts

2019-05-16

Expected to finish

2021-12-13

Last updated by the study team

2022-01-10

Who can join

Age: 29 and older, up to 75. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• - 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).

Where it is running

• David Holcomb — Sarasota, Florida, United States
• Gentile Facial Plastic and Aesthetic Laser Center — Youngstown, Ohio, United States

Full record on ClinicalTrials.gov

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