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

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)

Study Overview

• Status: Completed
• Conditions: Periorbital Edema
• Intervention / Treatment: Device: AccuTite; Device: AccuTite + Morpheus 8

Detailed Description

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
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Sarasota, Florida, United States, 34237
      • David Holcomb
  • Ohio
    • Youngstown, Ohio, United States, 44512
      • Gentile Facial Plastic and Aesthetic Laser center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 29 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: InMode MD Ltd.
• Investigators: Principal Investigator: David Holcomb, MD, Holcomb Kreithen Plastic Surgery and MedSpa; Principal Investigator: Richard Gentile, MD, Gentile Facial Plastic and Aesthetic Laser center

Study record dates

Study Major Dates

• Study Start (Actual): May 16, 2019
• Primary Completion (Actual): December 13, 2021
• Study Completion (Actual): December 13, 2021

Study Registration Dates

• First Submitted: September 23, 2019
• First Submitted That Met QC Criteria: September 24, 2019
• First Posted (Actual): September 25, 2019

Study Record Updates

• Last Update Posted (Actual): January 10, 2022
• Last Update Submitted That Met QC Criteria: January 5, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: DO608677A

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes