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

Periorbital Edema Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04103619
• Other study ID #: DO608677A
• Status: Completed
• Phase: N/A
• Start date: May 16, 2019
• Est. completion date: December 13, 2021

Study information

• Verified date: January 2022
• Source: InMode MD Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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)

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: December 13, 2021
• Est. primary completion date: December 13, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 29 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Periorbital Edema

Intervention

Device:
• AccuTite
Subjects will undergo treatment with AccuTite
• AccuTite + Morpheus 8
Subjects will undergo treatment with AccuTite and Morpheus 8

Locations

Country	Name	City	State
United States	David Holcomb	Sarasota	Florida
United States	Gentile Facial Plastic and Aesthetic Laser Center	Youngstown	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
InMode MD Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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