Clinical trial NCT04103619: Energy-Based Lower Eyelid Rejuvenation - Proof of Concept for InMode AccuTite With or Without Morpheus8
Official title: Energy-Based Lower Eyelid Rejuvenation - Proof of Concept for InMode AccuTite With or Without Morpheus8
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Periorbital Edema
Lead sponsor: InMode MD Ltd.
Sponsor class: INDUSTRY
First posted: 2019-09-25
Enrollment: 12
Sex: ALL
Minimum age (years): 29
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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)

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

Eligibility criteria: 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.

Primary outcomes:
measure: Correct identification at baseline and post treatment pictures
timeFrame: Change from baseline at 3 and 6 months
measure: Change in lower eyelid convexity scale
timeFrame: Change from baseline at 3 and 6 months
measure: Change in Festoonage scale
timeFrame: Change from baseline at 3 and 6 months
measure: Subject assessment of satisfaction
timeFrame: Change from baseline at 3 and 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Sarasota
country: United States
facility: David Holcomb
state: Florida
city: Youngstown
country: United States
facility: Gentile Facial Plastic and Aesthetic Laser Center
state: Ohio
Study officials:
affiliation: Holcomb Kreithen Plastic Surgery and MedSpa
name: David Holcomb, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Gentile Facial Plastic and Aesthetic Laser Center
name: Richard Gentile, MD
role: PRINCIPAL_INVESTIGATOR
References: