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Improvement of Skin AppearanceNCT04050033

Evoke Radiofrequency Device for Improvement of Skin Appearance

A study testing Evoke Device in people with Improvement of Skin Appearance, run by InMode MD Ltd. at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The aim of the study is to evaluate the safety, efficacy, patient comfort and patient satisfaction after Evoke treatment Read more about this study

Who is it for?
Ages 35 to 75 yearsHealthy volunteers can take part
Conditions the study is for
Improvement of Skin Appearance
What is being tested?
Evoke Device
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
3 sitesUnited States
Study dates
19 Jun 2019to 30 Dec 2021
Phase
Interventional
Are there results?
None posted in the registry

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 - 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 enrollment (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

3 sites in 1 country.

United States3 sites

  • Union Square Laser Dermatology

    New York, New York, 10003

  • BodySculpt

    New York, New York, 10019

  • Avance Plastic Surgery Institute

    Reno, Nevada, 89511

Other trials in United States

About this study

Official title: Clinical Study to Evaluate the Performance of Evoke Radiofrequency Device for Improvement of Skin Appearance

The aim of the study is to evaluate the safety, efficacy, patient comfort and patient satisfaction after Evoke treatment

Being tested
Evoke Device

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Evoke DeviceDevice

    Subjects will undergo treatment with Evoke Device

Study groups in NCT04050033
Study groupRoleWhat they receive
Treatment ArmExperimentalEnrolled subjects will undergo up to 3 successive bi-weekly (every 2 weeks) treatments (Tx.1, Tx.2 and Tx.3).
Receives: Device: Evoke Device

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of participants with Change in Skin Appearance

    Picture evaluation by blinded investigators.

    Measured: 1 month, 3 month, 6 months

  2. Evaluate rate of Change in Skin Appearance using 3D Photographic analysis

    3D Photographic analysis will be conducted using QuantifiCare System

    Measured: 1 month, 3 month, 6 months

  3. Evaluate changes in skin using VivoSight Optical Coherence Tomography (OCT) software

    Non-invasive in vivo skin imaging will be taken with the VivoSight Optical Coherence Tomography (OCT).

    Measured: 1 month, 3 month, 6 months

  4. Evaluate changes in skin appearance comparing photographs using Mechanical Turk (MTurk). The pictures will be sent through the system and evaluated by crowd workers.

    The pictures will be sent through the system and evaluated by crowd workers.

    Measured: 1 month, 3 month, 6 months

Secondary outcomes (3)

  1. Evaluate Investigator assessment of the skin appearance improvement

    Investigator assessment of the skin appearance improvement comparing pre and post treatment using 0 - 4 -points Likert scale at 1 month, 3 months and 6 months follow up visits:

    • 4 = Significantly marked improvement; 3 = Marked improvement; 2 = Moderate improvement; 1 = Slight improvement; 0 = No difference

    Measured: 1 Month, 3 Months, 6 Months

  2. Evaluate Subject assessment of improvement and satisfaction

    Improvement assessment will be performed independently by the subject himself 4 points Likert scale questionnaire (Global Aesthetic Improvement Scale), as follows:

    • 4 = Significantly marked improvement; 3 = Marked improvement; 2 = Moderate improvement; 1 = Slight improvement; 0 = No difference.

    Subject assessment of satisfaction will be filled out by subjects using a 5-points Likert scale, as follows:

    • +2 = Very satisfied; +1 = Satisfied; 0 = Indifferent; -1 = Disappointed; -2 = Very disappointed.

    Measured: 1 Month, 3 Months, 6 Months

  3. Evaluate histological changes to treatment area skin

    Positive changes in histologic evaluation: up to 5 subjects will undergo biopsies of the treated area for histology at baseline and at 3M follow-up visit. Histological sections will be stained using elastin, H\&E and other collagen specific stains.

    Measured: 3 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Aug 2019
  2. Study start19 Jun 2019
  3. Primary completion30 Dec 2021
  4. Study completion30 Dec 2021

Resources

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
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04050033
Sponsor's protocol ID
DO608679A
Status last verified
Jan 2022
First submitted
6 Aug 2019
Last updated
11 Jan 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Evoke Device in people with Improvement of Skin Appearance, run by InMode MD Ltd. at 3 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 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 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Number of participants with Change in Skin Appearance (time frame: 1 month, 3 month, 6 months). The study lists 4 primary outcomes in all. 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 NCT04050033.

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 Jan 2022.

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