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OpenTrials
Completed

NCT Number: NCT03945422

The Use of RF 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

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Key information

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chicago Center for Facial Plastics

Chicago, Illinois, 60611, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

AccuTite/FaceTite

Device

Radiofrequency-assisted lipolysis (RFAL) Morpheus8: Fractional RF

Other names: Morpheus8

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

InMode MD Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
May 10, 2019
Registry last updated
Jan 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.