Clinical trial NCT03945422: The Use of RF in Premature Jowl and Neck Laxity Following Facialplasty
Official title: The Use of Radio Frequency in Premature Jowl and Neck Laxity Following Facialplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Premature Jowl and Neck Laxity Following Facialplasty
Lead sponsor: InMode MD Ltd.
Sponsor class: INDUSTRY
First posted: 2019-05-10
Enrollment: 11
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Subjects will receive the treatment and outcome will be followed
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: Change in skin appearance
timeFrame: 3 months, 6 month, 9 months
Secondary outcomes:
measure: Investigator assessment of the skin appearance
timeFrame: 3 Month, 6 Months, 9 Months
measure: Optional: 3D Photographic analysis
timeFrame: 3 months, 6 month, 9 months
measure: Evaluate changes in skin appearance comparing photographs using Mechanical Turk (MTurk). The pictures will be sent through the system and evaluated by crowd workers.
timeFrame: 3 Months, 6 Months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Chicago Center for Facial Plastics
state: Illinois
Study officials:
References: