- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04719013
Treatment With the Evoke System for Facial and Submental Laxity
March 30, 2023 updated by: InMode MD Ltd.
The aim of the study is to evaluate the efficacy, patient comfort, and patient satisfaction after Evoke treatment for face and submental area
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
85
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Sacramento, California, United States, 95816
- Laser & Skin Surgery Medical Group
-
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Colorado
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Greenwood Village, Colorado, United States, 80111
- AboutSkin dermatology
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Louisiana
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New Orleans, Louisiana, United States, 70124
- Lupo Center for Aesthetic and General Dermatology
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Texas
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Dallas, Texas, United States, 75231
- Dallas Plastic Surgery Institute
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Houston, Texas, United States, 77081
- Refresh Dermatology
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
35 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
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.
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: treatment
Treatment areas include face, under chin (submental)
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Enrolled subjects will undergo up to 3 successive bi-weekly (every 2 weeks) treatments,
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evaluate Change in Skin Appearance
Time Frame: Month 6
|
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
Time Frame: 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.
0-no change, 1- mild improvement, 2- moderate improvement, 3- marked improvement, 4- significantly marked improvement
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month 6
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Evaluate Subject Assessment of Improvement and Satisfaction
Time Frame: month 6
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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
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Patient Satisfaction With the Procedure
Time Frame: month 6
|
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
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Rodney Rohrich, MD, Dallas Plastic Surgery Institute
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 1, 2020
Primary Completion (Actual)
July 15, 2022
Study Completion (Actual)
July 20, 2022
Study Registration Dates
First Submitted
December 24, 2020
First Submitted That Met QC Criteria
January 19, 2021
First Posted (Actual)
January 22, 2021
Study Record Updates
Last Update Posted (Actual)
March 31, 2023
Last Update Submitted That Met QC Criteria
March 30, 2023
Last Verified
March 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DO609886A
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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