Treatment With the Evoke System for Facial and Submental Laxity

NCT04719013 | Completed Results FDA Device

• 1 other identifier: DO609886A
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 5

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

Conditions

Laxity; Skin

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Evaluate Investigator Assessment of the Skin Appearance

  month 6

• Evaluate Subject Assessment of Improvement and Satisfaction

  month 6

• Patient Satisfaction With the Procedure

  month 6

Study Arms (1)

treatment

EXPERIMENTAL

Treatment areas include face, under chin (submental)

Device: Evoke radiofrequency device

Interventions

Evoke radiofrequency device DEVICE

Enrolled subjects will undergo up to 3 successive bi-weekly (every 2 weeks) treatments,

treatment

Eligibility Criteria

• Age: 35 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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.

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• InMode MD Ltd.: lead

Study Sites (5)

Laser & Skin Surgery Medical Group

Sacramento, California, 95816, United States

Location

AboutSkin dermatology

Greenwood Village, Colorado, 80111, United States

Location

Lupo Center for Aesthetic and General Dermatology

New Orleans, Louisiana, 70124, United States

Location

Dallas Plastic Surgery Institute

Dallas, Texas, 75231, United States

Location

Refresh dermatology

Houston, Texas, 77081, United States

Location

MeSH Terms

Conditions

Cutis Laxa

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Results Point of Contact

• Title: Maria Shusterman
• Organization: InMode

Maria.Shusterman@inmodemd.com

9057076787

Study Officials

• Rodney Rohrich, MD

  Dallas Plastic Surgery Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 24, 2020
• First Posted: January 22, 2021
• Study Start: December 1, 2020
• Primary Completion: July 15, 2022
• Study Completion: July 20, 2022
• Last Updated: March 31, 2023
• Results First Posted: March 31, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)