Laxity; SkinNCT04719013
Treatment With the Evoke System for Facial and Submental Laxity
A study testing Evoke radiofrequency device in people with Laxity; Skin, run by InMode MD Ltd. at 5 sites in United States.
Trial summary
The aim of the study is to evaluate the efficacy, patient comfort, and patient satisfaction after Evoke treatment for face and submental area Read more about this study
- Who is it for?
- Ages 35 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Laxity; Skin
- What is being tested?
- Evoke radiofrequency device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 5 sitesUnited States
- Study dates
- 1 Dec 2020to 20 Jul 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- - 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.
Who cannot join
- - 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.
Show all 16Show fewer
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Dallas Plastic Surgery Institute
Dallas, Texas, 75231
AboutSkin dermatology
Greenwood Village, Colorado, 80111
Refresh dermatology
Houston, Texas, 77081
Lupo Center for Aesthetic and General Dermatology
New Orleans, Louisiana, 70124
Laser & Skin Surgery Medical Group
Sacramento, California, 95816
About this study
The aim of the study is to evaluate the efficacy, patient comfort, and patient satisfaction after Evoke treatment for face and submental area
Read the 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.
- Conditions
- Laxity; Skin
- Being tested
- Evoke radiofrequency device
- Medical subject headings
- Cutis Laxa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evoke radiofrequency deviceDevice
Enrolled subjects will undergo up to 3 successive bi-weekly (every 2 weeks) treatments,
| Study group | Role | What they receive |
|---|---|---|
| treatment | Experimental | Treatment areas include face, under chin (submental) Receives: Device: Evoke radiofrequency device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate Change in Skin Appearance
Evaluate change in skin appearance comparing pre and 6 months post last treatment photographs (as assessed by blinded investigators)
Measured: Month 6
Secondary outcomes (3)
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
Measured: month 6
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.
Measured: month 6
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).
Measured: month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2021
- Study start1 Dec 2020
- Primary completion15 Jul 2022
- Study completion20 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Laxity; SkinStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- InMode MD Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rodney Rohrich, MD, Principal investigator, Dallas Plastic Surgery Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04719013
- Sponsor's protocol ID
- DO609886A
- Status last verified
- Mar 2023
- First submitted
- 24 Dec 2020
- Last updated
- 31 Mar 2023
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment With the Evoke System for Facial and Submental Laxity
- ClinicalTrials.gov ID
- NCT04719013
- Acronym / sponsor ID
- DO609886A
- Conditions
- Laxity; Skin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- InMode MD Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 15 Jul 2022 (actual)
- Study completion
- 20 Jul 2022 (actual)
- First posted
- 22 Jan 2021 (actual)
- Results
- Posted 31 Mar 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| treatment | Experimental | Device: Evoke radiofrequency deviceTreatment areas include face, under chin (submental) |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- - 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.
Key exclusion criteria (16 listed)
- - 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Evoke radiofrequency deviceEnrolled subjects will undergo up to 3 successive bi-weekly (every 2 weeks) treatments, | Device | treatment |
Primary outcome
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)
3 secondary outcomes
Evaluate Investigator Assessment of the Skin Appearance
Time frame: month 6
Evaluate Subject Assessment of Improvement and Satisfaction
Time frame: month 6
Patient Satisfaction With the Procedure
Time frame: month 6
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rodney Rohrich, MD principal investigator
Dallas Plastic Surgery Institute
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Evoke radiofrequency device in people with Laxity; Skin, run by InMode MD Ltd. at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Mar 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate Change in Skin Appearance (time frame: Month 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2023.