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

The Use of Radio Frequency in Premature Jowl and Neck Laxity Following Facialplasty

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

Study Overview

• Status: Completed
• Conditions: Premature Jowl and Neck Laxity Following Facialplasty
• Intervention / Treatment: Device: AccuTite/FaceTite

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Chicago Center for Facial Plastics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / 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 Names: Morpheus8

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 months, 6 month, 9 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 Month, 6 Months, 9 Months
Optional: 3D Photographic analysis	3D Photographic analysis will be conducted using QuantifiCare System	3 months, 6 month, 9 months
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.	3 Months, 6 Months

Collaborators and Investigators

• Sponsor: InMode MD Ltd.

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 15, 2019
• Primary Completion (ACTUAL): January 18, 2021
• Study Completion (ACTUAL): January 18, 2021

Study Registration Dates

• First Submitted: May 7, 2019
• First Submitted That Met QC Criteria: May 8, 2019
• First Posted (ACTUAL): May 10, 2019

Study Record Updates

• Last Update Posted (ACTUAL): January 10, 2022
• Last Update Submitted That Met QC Criteria: January 5, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Premature Birth
• Other Study ID Numbers: DO608522A

Drug and device information, study documents

• 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