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

NCT ID: NCT03945422

Last Updated: 2022-01-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-15
• Study Completion Date: 2021-01-18

Brief Summary

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

Conditions

Premature Jowl and Neck Laxity Following Facialplasty

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment Arm

Subject will receive AccuTite/FaceTite and Morpheus8 treatment

Group Type: EXPERIMENTAL

AccuTite/FaceTite

Intervention Type: DEVICE

Radiofrequency-assisted lipolysis (RFAL) Morpheus8: Fractional RF

Interventions

AccuTite/FaceTite

Radiofrequency-assisted lipolysis (RFAL) Morpheus8: Fractional RF

Intervention Type: DEVICE

Other Intervention Names

Morpheus8

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

InMode MD Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Chicago Center for Facial Plastics

Chicago, Illinois, United States

Countries

United States

Other Identifiers

DO608522A

Identifier Type: -

Identifier Source: org_study_id