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

NCT04103619 | Completed FDA Device

• 1 other identifier: DO608677A
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 2

Brief Summary

1. 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. 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)

Conditions

Periorbital Edema

Outcome Measures

Primary Outcomes (4)

• 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 1. = mild convexity lower eyelid 2. = moderate convexity lower eyelid 3. = 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 1. = single skin fold at or below inferior orbital rim 2. = double skin fold at or below inferior orbital rim 3. = 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

Study Arms (2)

AccuTite

ACTIVE COMPARATOR

15 patients will receive AccuTite treatment only

Device: AccuTite

AccuTite & Morpheus 8 Arm

ACTIVE COMPARATOR

15 patients will receive AccuTite and Morpheus8 treatment and additional 2 monthly Morpheus8 treatments

Device: AccuTite + Morpheus 8

Interventions

AccuTite DEVICE

Subjects will undergo treatment with AccuTite

AccuTite

AccuTite + Morpheus 8 DEVICE

Subjects will undergo treatment with AccuTite and Morpheus 8

AccuTite & Morpheus 8 Arm

Eligibility Criteria

• Age: 29 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• InMode MD Ltd.: lead

Study Sites (2)

David Holcomb

Sarasota, Florida, 34237, United States

Location

Gentile Facial Plastic and Aesthetic Laser Center

Youngstown, Ohio, 44512, United States

Location

MeSH Terms

Conditions

Orbital Cellulitis

Condition Hierarchy (Ancestors)

Orbital Diseases; Eye Diseases; Cellulitis; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Study Officials

• David Holcomb, MD

  Holcomb Kreithen Plastic Surgery and MedSpa

  PRINCIPAL INVESTIGATOR

• Richard Gentile, MD

  Gentile Facial Plastic and Aesthetic Laser Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2019
• First Posted: September 25, 2019
• Study Start: May 16, 2019
• Primary Completion: December 13, 2021
• Study Completion: December 13, 2021
• Last Updated: January 10, 2022

Record last verified: 2022-01

Locations

US (2)