Evaluation of the Evoke Radiofrequency Device for Improvement of Skin Appearance

Evaluation of the Evoke Radiofrequency Device for Improvement of Skin Appearance

Study Overview

• Status: Completed
• Conditions: Skin Laxity
• Intervention / Treatment: Device: Evoke Radiofrequency Device

Detailed Description

The aim of the study is to evaluate the safety, efficacy, patient comfort, and patient satisfaction after Evoke treatment

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Chestnut Hill, Massachusetts, United States, 02467
      • SkinCare Physicians

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 33 years to 73 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.
• As per the practitioner's discretion, refrain from treating any condition that might make it unsafe for the patient

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: treatment	Device: Evoke Radiofrequency Device; Enrolled subjects will undergo up to 3 successive bi-weekly (every 2 weeks) treatments.Treatment area will include face and under chin

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 6 months post last treatment photographs (as assessed by blinded investigators)	Day 0, Month 6
Evaluate Improvement in skin appearance	Evaluate Improvement in skin appearance using 3D Photographic analysis at 6 months follow up visits and compared to the baseline.	Day 0, month 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Investigator assessment of the skin appearance	Evaluate Investigator assessment of the skin appearance comparing pre and post-treatment using 0 - 4 -points Likert scale at 6 months follow up visits.	month 6
Subject assessment of change and satisfaction	Evaluate Subject assessment of change and satisfaction using 0 - 4 -points Likert scale at 6 months follow up visits.	month 6
Histological Analysis - Quantitative analysis of collagen fibers (up to 5 subjects)	Quantitative analysis of collagen will be performed with the Image software by semi-automatic segmentation in HSB (Hue-Saturation-Brightness) color system. The change from baseline will be calculated at 3 months time frame.	Day 0, month 3

Collaborators and Investigators

• Sponsor: InMode MD Ltd.
• Investigators: Principal Investigator: Jeffrey Dover, MD, SkinCare Physicians

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2020
• Primary Completion (Actual): July 28, 2022
• Study Completion (Actual): July 28, 2022

Study Registration Dates

• First Submitted: December 24, 2020
• First Submitted That Met QC Criteria: January 21, 2021
• First Posted (Actual): January 22, 2021

Study Record Updates

• Last Update Posted (Actual): August 3, 2022
• Last Update Submitted That Met QC Criteria: August 2, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Genetic Diseases, Inborn; Connective Tissue Diseases; Skin Diseases, Genetic; Cutis Laxa
• Other Study ID Numbers: DO609576A

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• 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.: No