Clinical Evaluation of the Safety and Efficacy of a 1060 nm Diode Laser, Pulsed ElectroMagnetic Fields and Vacuum Assisted Multipolar Radio Frequency for Non-invasive Fat Reduction of the Abdomen and Flanks
Venus Bliss
Treatment Study
Summary
Study start date: September 19, 2019
Actual date on which the first participant was enrolled.Open-label, baseline-controlled, multi-center study evaluating a 1060 nm diode laser, pulsed electromagnetic fields, and vacuum-assisted radio frequency for non-invasive fat reduction of the abdomen and flanks. The study will enroll up to 200 subjects requesting non-invasive lipolysis of the abdomen and flanks. Each subject will receive 3 study treatments of the diode laser and 3 treatments of the pulsed electromagnetic fields and vacuum assisted radio frequency. Subjects will be followed at twelve weeks post-final diode treatment. The twelve-week post-treatment outcome will be compared to the baseline.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.39 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Criteria
Inclusion Criteria: * 1\. Able to read, understand and voluntarily provide written informed consent. 2. Healthy male or female, ≥ 18 years of age seeking treatment for unwanted fat in the flanks. 3\. BMI score is less than 35. 4. Agree to not making any major changes in their diet or lifestyle during the course of the study. 5\. Able and willing to comply with the treatment/follow-up schedule and requirements. 6\. Women of child-bearing age are required to be using a reliable method of birth control at least 3 months prior to study enrollment and for the duration of the study, and have a negative Urine Pregnancy test at baseline. Exclusion Criteria: * 1\. Pregnant in the last 3 months, intending to become pregnant, postpartum or nursing in the last 6 months. 2\. Any previous liposuction/lipo-sculpture or any type of surgical procedure in the treatment area in the past 12 months. 3\. History of immunosuppression/immune deficiency disorders (including AIDS and HIV infection) or use of immunosuppressive medications, 6 months prior to and during the course of the study. 4\. History of hyperlipidemia, diabetes mellitus, hepatitis, blood coagulopathy or excessive bleeding. 5\. Use of antiplatelet medications (81 mg acetylsalicylic acid daily permitted), anticoagulants, thrombolytics or anti-inflammatory medications within 2 weeks of treatment. 6\. Having a history of skin cancer or any other cancer in the areas to be treated, including presence of malignant or pre-malignant pigmented lesions. 7\. Having a permanent implant in the treatment area such as metal plates or an injected chemical substance such as silicone or parenteral gold therapy (gold sodium thiomalate). 8\. Use of medications, herbs, food supplements, and vitamins known to induce photosensitivity to light exposure at the wavelength used or history of photosensitivity disorder. 9\. Suffering from significant skin conditions in the treatment area or inflammatory skin conditions including but not limited to open lacerations, abrasions, herpes sores, cold sores, active infections. 10\. Tattoos in the treatment area. 11. Poor skin quality (severe laxity). 12. Abdominal wall, muscular abnormality or hernia on physical examination. 13. Use of retinoids such as oral isotretinoin (Accutane™) within the past six months or during course of the study. 14\. History of keloid or hypertrophic scar formation or poor wound healing in the treatment area. 15\. As per the investigator's discretion, any physical or mental condition which may make it unsafe for the subject to participate. 16\. Unable or unlikely to refrain from sun exposure, artificial tanning, including the use of tanning booths, prior to (six weeks) and during the course of the evaluation.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 5 locations
Laser & Skin Surgery Medical Group, Inc
Sacramento, United StatesBatra Dermatology
Santa Monica, United StatesaFresh Medispa
Chicago, United States