Treatment With the Evoke System for Facial and Submental Laxity

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to evaluate the efficacy, patient comfort, and patient satisfaction after Evoke treatment for face and submental area

Detailed Description
-----------------
The aim of the study is to evaluate the efficacy, patient comfort, and patient satisfaction after Evoke treatment for face and submental area Prospective, open label clinical study.

Official Title
-----------------
Treatment With the Evoke System for Facial and Submental Laxity

Conditions
-----------------
Laxity; Skin

Intervention / Treatment
-----------------
* Device: Evoke radiofrequency device


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Signed informed consent to participate in the study. Female and male subjects, 35 and 75 years of age at the time of enrolment If female, not pregnant, lactating and must be either post-menopausal, surgically sterilized, or using a medically acceptable form of birth control at least 3 months prior to enrolment (i.e., oral contraceptives, contraceptive implant, barrier methods with spermicide or abstinence). In addition, negative urine pregnancy test as tested before each treatment and at the last visit for women with childbearing potential (e.g. not menopause). General good health confirmed by medical history and skin examination of the treated area. Willing to have photographs and images taken of the treated areas to be used de-identified in evaluations, publications and presentations. 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. Permanent implant in the treated area such as metal plates and screws, silicone implants or an injected chemical substance, unless deep enough in the periostal plane. Current or history of skin cancer, or current condition of any other type of cancer, or premalignant moles. Severe concurrent conditions, such as cardiac disorders, epilepsy, uncontrolled hypertension, and liver or kidney diseases. Pregnancy and nursing. Impaired immune system due to immunosuppressive diseases such as AIDS and HIV, or use of immunosuppressive medications. Patients with history of diseases stimulated by heat, such as recurrent Herpes Simplex in the treatment area, may be treated only following a prophylactic regimen. Poorly controlled endocrine disorders, such as diabetes or thyroid dysfunction. 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. History of bleeding coagulopathies or use of anticoagulants in the last 10 days. Any surgery in treated area within 3 months prior to treatment. Six months delay is required if other recent treatments like light, CO2 laser or RF were performed on the same area. Use of Isotretinoin (Accutane®) within 6 months prior to treatment. Simultaneously participating in another investigator drug or device study or has completed the follow-up phase for the primary endpoint of any previous study less than 1 year prior to the first evaluation in this study. As per the practitioner's discretion, refrain from treating any condition that might make it unsafe for the patient

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: treatment<br>Treatment areas include face, under chin (submental) | Device: Evoke radiofrequency device<br>* Enrolled subjects will undergo up to 3 successive bi-weekly (every 2 weeks) treatments,<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate Change in Skin Appearance | Evaluate change in skin appearance comparing pre and 6 months post last treatment photographs (as assessed by blinded investigators) | Month 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate Investigator Assessment of the Skin Appearance | Evaluate Investigator assessment of the skin appearance improvement comparing pre and post treatment using 0 - 4 -points Likert scale at 6 months follow up visits. 0-no change, 1- mild improvement, 2- moderate improvement, 3- marked improvement, 4- significantly marked improvement | month 6 | 
| Evaluate Subject Assessment of Improvement and Satisfaction | Evaluate Subject assessment of improvement and satisfaction using 0 - 4 -points Likert scale at 6 months follow up visits, Improvement: 0-no change, 1- mild improvement, 2- moderate improvement, 3-marked improvement, 4- significantly marked improvement. | month 6 | 
| Patient Satisfaction With the Procedure | Finally, patients assessed their satisfaction with the procedure at 6 months post-treatment. Patients utilized a scale anchored by -2 (very disappointed) and 2 (very satisfied). | month 6 |