ClinicalTrials.Veeva

Menu

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

InMode logo

InMode

Status

Completed

Conditions

Premature Jowl and Neck Laxity Following Facialplasty

Treatments

Device: AccuTite/FaceTite

Study type

Interventional

Funder types

Industry

Identifiers

NCT03945422
DO608522A

Details and patient eligibility

About

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

Enrollment

11 patients

Sex

All

Ages

40 to 80 years old

Volunteers

Accepts 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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

11 participants in 1 patient group

Treatment Arm
Experimental group
Description:
Subject will receive AccuTite/FaceTite and Morpheus8 treatment
Treatment:
Device: AccuTite/FaceTite

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems