Treatment With the Evoke System for Facial and Submental Laxity

Laxity; Skin Clinical Trial

Official title:

Treatment With the Evoke System for Facial and Submental Laxity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04719013
• Other study ID #: DO609886A
• Status: Completed
• Phase: N/A
• Start date: December 1, 2020
• Est. completion date: July 20, 2022

Study information

• Verified date: March 2023
• Source: InMode MD Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of the study is to evaluate the efficacy, patient comfort, and patient satisfaction after Evoke treatment for face and submental area

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 85
• Est. completion date: July 20, 2022
• Est. primary completion date: July 15, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 35 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Cutis Laxa
• Laxity; Skin

Intervention

Device:
• Evoke radiofrequency device
Enrolled subjects will undergo up to 3 successive bi-weekly (every 2 weeks) treatments,

Locations

Country	Name	City	State
United States	Dallas Plastic Surgery Institute	Dallas	Texas
United States	AboutSkin dermatology	Greenwood Village	Colorado
United States	Refresh dermatology	Houston	Texas
United States	Lupo Center for Aesthetic and General Dermatology	New Orleans	Louisiana
United States	Laser & Skin Surgery Medical Group	Sacramento	California

Sponsors (1)

Lead Sponsor	Collaborator
InMode MD Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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