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Completed

NCT Number: NCT04103619

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)

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Key information

Age range

29 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

David Holcomb, Sarasota, Florida, United States

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About this study

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).

  • 15 patients will receive AccuTite treatment only (7-8 patients per arm at each of the two study sites)
  • 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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

AccuTite

Device

Subjects will undergo treatment with AccuTite

AccuTite + Morpheus 8

Device

Subjects will undergo treatment with AccuTite and Morpheus 8

Primary outcomes

  1. Correct identification at baseline and post treatment pictures

    Time frame: Change from baseline at 3 and 6 months

    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.

  2. Change in lower eyelid convexity scale

    Time frame: Change from baseline at 3 and 6 months

    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
  3. Change in Festoonage scale

    Time frame: Change from baseline at 3 and 6 months

    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
  4. Subject assessment of satisfaction

    Time frame: Change from baseline at 3 and 6 months

    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

Sponsors and collaborators

Lead sponsor

InMode MD Ltd.

Industry

Registry information

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Sep 25, 2019
Registry last updated
Jan 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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