Clinical trial NCT04050033: Evoke Radiofrequency Device for Improvement of Skin Appearance
Official title: Clinical Study to Evaluate the Performance of Evoke Radiofrequency Device for Improvement of Skin Appearance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Improvement of Skin Appearance
Lead sponsor: InMode MD Ltd.
Sponsor class: INDUSTRY
First posted: 2019-08-08
Enrollment: 30
Sex: ALL
Minimum age (years): 35
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: Inclusion Criteria:

* - 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.

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.
* As per the practitioner's discretion, refrain from treating any condition that might make it unsafe for the patient

Primary outcomes:
measure: Number of participants with Change in Skin Appearance
timeFrame: 1 month, 3 month, 6 months
measure: Evaluate rate of Change in Skin Appearance using 3D Photographic analysis
timeFrame: 1 month, 3 month, 6 months
measure: Evaluate changes in skin using VivoSight Optical Coherence Tomography (OCT) software
timeFrame: 1 month, 3 month, 6 months
measure: Evaluate changes in skin appearance comparing photographs using Mechanical Turk (MTurk). The pictures will be sent through the system and evaluated by crowd workers.
timeFrame: 1 month, 3 month, 6 months
Secondary outcomes:
measure: Evaluate Investigator assessment of the skin appearance improvement
timeFrame: 1 Month, 3 Months, 6 Months
measure: Evaluate Subject assessment of improvement and satisfaction
timeFrame: 1 Month, 3 Months, 6 Months
measure: Evaluate histological changes to treatment area skin
timeFrame: 3 Months
Other outcomes:
Locations:
city: Reno
country: United States
facility: Avance Plastic Surgery Institute
state: Nevada
city: New York
country: United States
facility: Union Square Laser Dermatology
state: New York
city: New York
country: United States
facility: BodySculpt
state: New York
Study officials:
affiliation: Avance Plastic Surgery Institute 5570 Longley Lane, Suite A Reno, NV 89511
name: Erez Dayan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: BodySculpt 128 Central Park S New York, NY 10019
name: Christopher Chia, MD
role: PRINCIPAL_INVESTIGATOR
References: