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出境医 / 临床实验 / The Use of RF in Premature Jowl and Neck Laxity Following Facialplasty

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

Study Description
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
Layout table for study information
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
Estimated Primary Completion Date : April 3, 2020
Estimated Study Completion Date : April 3, 2020
Arms and Interventions
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
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
Layout table for eligibility information
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

Locations
Layout table for location information
United States, Illinois
Chicago Center for Facial Plastics
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
InMode MD Ltd.
Tracking Information
First Submitted Date  ICMJE May 7, 2019
First Posted Date  ICMJE May 10, 2019
Last Update Posted Date September 25, 2019
Actual Study Start Date  ICMJE April 15, 2019
Estimated Primary Completion Date April 3, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 23, 2019) 		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.
Original Primary Outcome Measures  ICMJE
 (submitted: May 8, 2019)
  • 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.
  • Change between the FACE-Q score [ Time Frame: 3 months, 6 month, 9 months ]
    Evaluate changes in facial apparent and patient satisfaction assessed by FACE-Q scale after 3, 6 and 9 month post treatment compared to baseline (before treatment)
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 23, 2019)
  • 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.
  • Optional: 3D Photographic analysis [ Time Frame: 3 months, 6 month, 9 months ]
    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. [ Time Frame: 3 Months, 6 Months ]
    The pictures will be sent through the system and evaluated by crowd workers.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 8, 2019)
  • 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.
  • Optional: 3D Photographic analysis [ Time Frame: 3 months, 6 month, 9 months ]
    3D Photographic analysis will be conducted using QuantifiCare System
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Use of RF in Premature Jowl and Neck Laxity Following Facialplasty
Official Title  ICMJE The Use of Radio Frequency in Premature Jowl and Neck Laxity Following Facialplasty
Brief Summary Study is to evaluate the efficacy of treatment Radio Frequency in premature jowl and neck laxity following facialplasty
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Premature Jowl and Neck Laxity Following Facialplasty
Intervention  ICMJE Device: AccuTite/FaceTite
Radiofrequency-assisted lipolysis (RFAL) Morpheus8: Fractional RF
Other Name: Morpheus8
Study Arms  ICMJE Experimental: Treatment Arm
Subject will receive AccuTite/FaceTite and Morpheus8 treatment
Intervention: Device: AccuTite/FaceTite
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: September 23, 2019) 		11
Original Estimated Enrollment  ICMJE
 (submitted: May 8, 2019) 		10
Estimated Study Completion Date  ICMJE April 3, 2020
Estimated Primary Completion Date April 3, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03945422
Other Study ID Numbers  ICMJE DO608522A
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Responsible Party InMode MD Ltd.
Study Sponsor  ICMJE InMode MD Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account InMode MD Ltd.
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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