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The Use of RF in Premature Jowl and Neck Laxity Following Facialplasty

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ClinicalTrials.gov Identifier: NCT03945422
Recruitment Status : Completed
First Posted : May 10, 2019
Last Update Posted : January 10, 2022
Sponsor:
Information provided by (Responsible Party):
InMode MD Ltd.

Study Description
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Brief Summary:
Study is to evaluate the efficacy of treatment Radio Frequency in premature jowl and neck laxity following facialplasty

Condition or disease Intervention/treatment Phase
Premature Jowl and Neck Laxity Following Facialplasty Device: AccuTite/FaceTite Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Subjects will receive the treatment and outcome will be followed
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Use of Radio Frequency in Premature Jowl and Neck Laxity Following Facialplasty
Actual Study Start Date : April 15, 2019
Actual Primary Completion Date : January 18, 2021
Actual Study Completion Date : January 18, 2021
Arms and Interventions
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Arm Intervention/treatment
Experimental: Treatment Arm
Subject will receive AccuTite/FaceTite and Morpheus8 treatment
 Device: AccuTite/FaceTite
Radiofrequency-assisted lipolysis (RFAL) Morpheus8: Fractional RF
Other Name: Morpheus8


Outcome Measures
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Primary Outcome Measures :
  1. Change in skin appearance [ Time Frame: 3 months, 6 month, 9 months ]
    Photos from all time points (baseline and follow-up visits) will be evaluated by the treating physician and 2 independent evaluators.


Secondary Outcome Measures :
  1. Investigator assessment of the skin appearance [ Time Frame: 3 Month, 6 Months, 9 Months ]
    Investigator assessment of the skin appearance improvement comparing pre and post treatment using 0 - 4 -points Likert scale: 4 = Significantly marked improvement; 3 = Marked improvement; 2 = Moderate improvement; 1 = Slight improvement ; 0 = No difference.

  2. Optional: 3D Photographic analysis [ Time Frame: 3 months, 6 month, 9 months ]
    3D Photographic analysis will be conducted using QuantifiCare System

  3. Evaluate changes in skin appearance comparing photographs using Mechanical Turk (MTurk). The pictures will be sent through the system and evaluated by crowd workers. [ Time Frame: 3 Months, 6 Months ]
    The pictures will be sent through the system and evaluated by crowd workers.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Adult females and males between the ages of 40-80 inclusive, having premature jowl and/or neck laxity one to fifteen years following facialplasty, seeking skin tightening treatments.
  • Lack lipodystrophy in the jowl or neck area or at least not amenable to liposuction improvement (not a candidate for liposuction).
  • Lack of previous Face Lift complications (no nerve injury or hematoma history).
  • 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 thepermission 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:

  • 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 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 hormonalvirilization.
  • 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 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).
  • As per the practitioner's discretion, refrain from treating any condition that might make it unsafe for the patient.
Contacts and Locations
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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): NCT03945422


Locations
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United States, Illinois
Chicago Center for Facial Plastics
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
InMode MD Ltd.
More Information
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Responsible Party: InMode MD Ltd.
ClinicalTrials.gov Identifier: NCT03945422    
Other Study ID Numbers: DO608522A
First Posted: May 10, 2019    Key Record Dates
Last Update Posted: January 10, 2022
Last Verified: January 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications