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Treatment With the Evoke System for Facial and Submental Laxity

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04719013
Recruitment Status : Active, not recruiting
First Posted : January 22, 2021
Last Update Posted : November 10, 2021
Sponsor:
Information provided by (Responsible Party):
InMode MD Ltd.

Study Description
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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

Condition or disease Intervention/treatment Phase
Laxity; Skin Device: Evoke radiofrequency device Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Treatment With the Evoke System for Facial and Submental Laxity
Actual Study Start Date : December 1, 2020
Estimated Primary Completion Date : February 1, 2022
Estimated Study Completion Date : February 1, 2022

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Arms and Interventions
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Arm Intervention/treatment
Experimental: treatment Device: Evoke radiofrequency device
Enrolled subjects will undergo up to 3 successive bi-weekly (every 2 weeks) treatments,


Outcome Measures
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Primary Outcome Measures :
  1. Evaluate change in skin appearance [ Time Frame: Day 0, Month 6 ]
    Evaluate change in skin appearance comparing pre and 6 months post last treatment photographs (as assessed by blinded investigators)

  2. Evaluate change in skin appearance using 3D Photographic analysis [ Time Frame: Day 0, month 6 ]
    Evaluate change in skin appearance using 3D Photographic analysis at 6 months follow up visit compared to the baseline.


Secondary Outcome Measures :
  1. Evaluate Investigator assessment of the skin appearance [ Time Frame: Day 0, month 6 ]
    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.

  2. Evaluate Subject assessment of improvement and satisfaction [ Time Frame: month 6 ]
    Evaluate Subject assessment of improvement and satisfaction using 0 - 4 -points Likert scale at 6 months follow up visits

  3. Histological Analysis - Collagen (up to 5 subjects) [ Time Frame: Day 0, month 3 ]
    Relative changes in protein abundance in biopsies taken at post treatment compare to control will be quantified using an image processing software based on fluorescence signal intensity. The change from baseline will be calculated at 3M time frame.


Eligibility Criteria
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Ages Eligible for Study:   35 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04719013


Locations
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United States, California
Laser & Skin Surgery Medical Group
Sacramento, California, United States, 95816
United States, Colorado
AboutSkin dermatology
Greenwood Village, Colorado, United States, 80111
United States, Louisiana
Lupo Center for Aesthetic and General Dermatology
New Orleans, Louisiana, United States, 70124
United States, Texas
Dallas Plastic Surgery Institute
Dallas, Texas, United States, 75231
Refresh dermatology
Houston, Texas, United States, 77081
Sponsors and Collaborators
InMode MD Ltd.
More Information
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Responsible Party: InMode MD Ltd.
ClinicalTrials.gov Identifier: NCT04719013    
Other Study ID Numbers: DO609886A
First Posted: January 22, 2021    Key Record Dates
Last Update Posted: November 10, 2021
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Cutis Laxa
Skin Diseases, Genetic
Genetic Diseases, Inborn
Connective Tissue Diseases
Skin Diseases