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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/14/2021.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/14/2021.

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

Clinicaltrials.gov identifier NCT03945422

Recruitment Status Active, not recruiting

First Posted May 10, 2019

Last update posted September 25, 2019

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:Premature Jowl and Neck Laxity Following Facialplasty
  • Intervention/Treatment: Device: AccuTite/FaceTite
  • Phase: N/A
Detailed Description

N/A

Study Design
  • Study Type: Interventional
  • Actual Enrollment: 11 participants
  • 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 2019
  • Estimated Primary Completion Date: April 2020
  • Estimated Study Completion Date: April 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
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
  • Ages Eligible for Study: 40 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
Contacts
Locations

United States, Illinois
Chicago Center for Facial Plastics
Chicago

Sponsors and Collaborators

InMode MD Ltd.

More Information
  • Responsible Party: InMode MD Ltd.
  • ClinicalTrials.gov Identifier: NCT03945422 History of Changes
  • Other Study ID Numbers: DO608522A
  • First Posted: May 10, 2019 Key Record Dates
  • Last Update Posted: September 25, 2019
  • Last Verified: September 2019
  • 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
  • Additional relevant MeSH terms: Premature Birth