Skin LaxityNCT04721600
Evaluation of the Evoke Radiofrequency Device for Improvement of Skin Appearance
A study testing Evoke Radiofrequency Device in people with Skin Laxity, run by InMode MD Ltd. at 1 site in United States.
Trial summary
Evaluation of the Evoke Radiofrequency Device for Improvement of Skin Appearance Read more about this study
- Who is it for?
- Ages 35 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Skin Laxity
- 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
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2020to 28 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 15Show 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.
- As per the practitioner's discretion, refrain from treating any condition that might make it unsafe for the patient
Trial locations and contacts
1 site in 1 country.
United States1 site
Skincare physicians
Chestnut Hill, Massachusetts, 02467
About this study
Evaluation of the Evoke Radiofrequency Device for Improvement of Skin Appearance
Read the detailed description
The aim of the study is to evaluate the safety, efficacy, patient comfort, and patient satisfaction after Evoke treatment
- Conditions
- Skin Laxity
- 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.Treatment area will include face and under chin
| Study group | Role | What they receive |
|---|---|---|
| treatment | Experimental | Subjects aged 35-75, healthy adults with visible signs of aging, seeking skin laxity treatments. three treatments Receives: Device: Evoke Radiofrequency Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Baseline and 6 Month Face Photographs Correctly Identified by Two Blind Evaluators
Measured: 6 months
Secondary outcomes (2)
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.
Measured: month 6
Subject Assessment of Change and Satisfaction With the Procedure
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 Nov 2020
- Primary completion28 Jul 2022
- Study completion28 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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Skin LaxityStudies 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
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- InMode MD Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jeffrey Dover, MD, Principal investigator, Skincare physicians
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04721600
- Sponsor's protocol ID
- DO609576A
- Status last verified
- Jun 2024
- First submitted
- 24 Dec 2020
- Last updated
- 11 Jun 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
Labadie JG, Chilukuri S, Cohen J, Kilmer S, Lupo M, Rohrich R, Dover JS. Noninvasive Hands-free Bipolar Radiofrequency Facial Remodeling Device for the Improvement of Skin Appearance. Dermatol Surg. 2023 Jan 1;49(1):54-59. doi: 10.1097/DSS.0000000000003666. Epub 2022 Dec 8.
PubMed 36533797
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Evoke Radiofrequency Device for Improvement of Skin Appearance
- ClinicalTrials.gov ID
- NCT04721600
- Acronym / sponsor ID
- DO609576A
- Conditions
- Skin Laxity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- InMode MD Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 28 Jul 2022 (actual)
- Study completion
- 28 Jul 2022 (actual)
- First posted
- 22 Jan 2021 (actual)
- Results
- Posted 11 Jun 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluation of the Evoke Radiofrequency Device for Improvement of Skin Appearance
Detailed description
The aim of the study is to evaluate the safety, efficacy, patient comfort, and patient satisfaction after Evoke treatment
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 DeviceSubjects aged 35-75, healthy adults with visible signs of aging, seeking skin laxity treatments. three treatments |
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 (15 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.Treatment area will include face and under chin | Device | treatment |
Primary outcome
Percentage of Participants With Baseline and 6 Month Face Photographs Correctly Identified by Two Blind Evaluators
Time frame: 6 months
2 secondary outcomes
Investigator Assessment of the Skin Appearance
Time frame: month 6
Subject Assessment of Change and 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 11 Jun 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36533797Labadie JG, Chilukuri S, Cohen J, Kilmer S, Lupo M, Rohrich R, Dover JS. Noninvasive Hands-free Bipolar Radiofrequency Facial Remodeling Device for the Improvement of Skin Appearance. Dermatol Surg. 2023 Jan 1;49(1):54-59. doi: 10.1097/DSS.0000000000003666. Epub 2022 Dec 8.
- Individual participant dataSharing planned: Undecided
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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.
Jeffrey Dover, MD principal investigator
Skincare physicians
1 site 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 Skin Laxity, run by InMode MD Ltd. at 1 site 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 15 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 11 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 11 Jun 2024). 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?
Percentage of Participants With Baseline and 6 Month Face Photographs Correctly Identified by Two Blind Evaluators (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04721600, which also lists 1 linked publication.
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 11 Jun 2024.