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

Primary Purpose

Premature Jowl and Neck Laxity Following Facialplasty

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
AccuTite/FaceTite
Sponsored by
InMode MD Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Premature Jowl and Neck Laxity Following Facialplasty

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Chicago Center for Facial Plastics

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment Arm

Arm Description

Subject will receive AccuTite/FaceTite and Morpheus8 treatment

Outcomes

Primary Outcome Measures

Change in skin appearance
Photos from all time points (baseline and follow-up visits) will be evaluated by the treating physician and 2 independent evaluators.

Secondary Outcome Measures

Investigator assessment of the skin appearance
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.
Optional: 3D Photographic analysis
3D Photographic analysis will be conducted using QuantifiCare System
Evaluate changes in skin appearance comparing photographs using Mechanical Turk (MTurk). The pictures will be sent through the system and evaluated by crowd workers.
The pictures will be sent through the system and evaluated by crowd workers.

Full Information

First Posted
May 7, 2019
Last Updated
January 5, 2022
Sponsor
InMode MD Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT03945422
Brief Title
The Use of RF in Premature Jowl and Neck Laxity Following Facialplasty
Official Title
The Use of Radio Frequency in Premature Jowl and Neck Laxity Following Facialplasty
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
April 15, 2019 (Actual)
Primary Completion Date
January 18, 2021 (Actual)
Study Completion Date
January 18, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
InMode MD Ltd.

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premature Jowl and Neck Laxity Following Facialplasty

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Subjects will receive the treatment and outcome will be followed
Masking
None (Open Label)
Allocation
N/A
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment Arm
Arm Type
Experimental
Arm Description
Subject will receive AccuTite/FaceTite and Morpheus8 treatment
Intervention Type
Device
Intervention Name(s)
AccuTite/FaceTite
Other Intervention Name(s)
Morpheus8
Intervention Description
Radiofrequency-assisted lipolysis (RFAL) Morpheus8: Fractional RF
Primary Outcome Measure Information:
Title
Change in skin appearance
Description
Photos from all time points (baseline and follow-up visits) will be evaluated by the treating physician and 2 independent evaluators.
Time Frame
3 months, 6 month, 9 months
Secondary Outcome Measure Information:
Title
Investigator assessment of the skin appearance
Description
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.
Time Frame
3 Month, 6 Months, 9 Months
Title
Optional: 3D Photographic analysis
Description
3D Photographic analysis will be conducted using QuantifiCare System
Time Frame
3 months, 6 month, 9 months
Title
Evaluate changes in skin appearance comparing photographs using Mechanical Turk (MTurk). The pictures will be sent through the system and evaluated by crowd workers.
Description
The pictures will be sent through the system and evaluated by crowd workers.
Time Frame
3 Months, 6 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Facility Information:
Facility Name
Chicago Center for Facial Plastics
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States

12. IPD Sharing Statement

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

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