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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04103619
Recruitment Status : Recruiting
First Posted : September 25, 2019
Last Update Posted : September 25, 2019
Sponsor:
Information provided by (Responsible Party):
InMode MD Ltd.

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)

Condition or disease Intervention/treatment Phase
Periorbital Edema Device: AccuTite Device: AccuTite + Morpheus 8 Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Energy-Based Lower Eyelid Rejuvenation - Proof of Concept for InMode AccuTite With or Without Morpheus8
Actual Study Start Date : May 16, 2019
Estimated Primary Completion Date : January 15, 2021
Estimated Study Completion Date : January 15, 2021

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




Primary Outcome Measures :
  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

    1. = mild convexity lower eyelid
    2. = moderate convexity lower eyelid
    3. = 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

    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

  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




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   29 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04103619


Contacts
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Contact: Leon Grach 8554112639 Leon.Grach@inmodemd.com
Contact: Maria Shusterman 8554112639 marias@inmodemd.com

Locations
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United States, Florida
David Holcomb Recruiting
Sarasota, Florida, United States, 34237
Contact: David Holcomb    866-218-4810      
United States, Ohio
Gentile Facial Plastic and Aesthetic Laser Center Recruiting
Youngstown, Ohio, United States, 44512
Contact: Richard Gentile, MD    330-758-2001      
Sponsors and Collaborators
InMode MD Ltd.
Investigators
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Principal Investigator: David Holcomb, MD Holcomb Kreithen Plastic Surgery and MedSpa
Principal Investigator: Richard Gentile, MD Gentile Facial Plastic and Aesthetic Laser Center

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Responsible Party: InMode MD Ltd.
ClinicalTrials.gov Identifier: NCT04103619    
Other Study ID Numbers: DO608677A
First Posted: September 25, 2019    Key Record Dates
Last Update Posted: September 25, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes