Laxity; Skin
Conditions
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
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.
Interventions
Enrolled subjects will undergo up to 3 successive bi-weekly (every 2 weeks) treatments,
Sponsors
InMode MD Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
35 Years to 75 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate Change in Skin Appearance | Month 6 | Evaluate change in skin appearance comparing pre and 6 months post last treatment photographs (as assessed by blinded investigators) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate Investigator Assessment of the Skin Appearance | 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 |
| Evaluate Subject Assessment of Improvement and Satisfaction | month 6 | 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. |
| Patient Satisfaction With the Procedure | 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Treatment Treatment areas include face, under chin (submental)
Evoke radiofrequency device: Enrolled subjects will undergo up to 3 successive bi-weekly (every 2 weeks) treatments, | 85 |
| Total | 85 |
Baseline characteristics
| Characteristic | Treatment | — |
|---|---|---|
| Age, Continuous | 53.49 years | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 82 Participants | — |
| Sex: Female, Male Male | 3 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 85 |
| other Total, other adverse events | 5 / 85 |
| serious Total, serious adverse events | 0 / 85 |
Outcome results
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)
Time frame: Month 6
Population: 2 of 3 blind evaluators would agree on skin appearance based on photographs for 70% of patients
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment | Evaluate Change in Skin Appearance | 80.7 percentage of participants |
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
Time frame: month 6
Population: Investigator assessment of the skin appearance improvement comparing pre and post-treatment using 0 - 4 -points Likert scale at 6 months follow-up visits.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Treatment | Evaluate Investigator Assessment of the Skin Appearance | 1 score on a scale |
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.
Time frame: month 6
Population: Patients assessed the level of their skin appearance improvement at 6 months post-treatment. Patients utilized a scale anchored by 0 (no difference) and 4 (significantly marked improvement)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Treatment | Evaluate Subject Assessment of Improvement and Satisfaction | 1 score on a scale |
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).
Time frame: month 6
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Treatment | Patient Satisfaction With the Procedure | 0.62 score on a scale |