Clinical Evaluation of a 1060 nm Diode Laser, PEMF and Vacuum Assisted MP RF for Non-invasive Fat Reduction

Completed · Not applicable

Conditions studied: Adipose Tissue Atrophy

In brief

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.

Key facts

Study ID

NCT04012814

Run by

Venus Concept

People needed

39

Starts

2019-09-19

Expected to finish

2022-10-22

Last updated by the study team

2024-04-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.
• 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.
• Able and willing to comply with the treatment/follow-up schedule and requirements.
• 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.

You may not qualify if…

• 1. Pregnant in the last 3 months, intending to become pregnant, postpartum or nursing in the last 6 months.
• Any previous liposuction/lipo-sculpture or any type of surgical procedure in the treatment area in the past 12 months.
• 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.
• History of hyperlipidemia, diabetes mellitus, hepatitis, blood coagulopathy or excessive bleeding.
• Use of antiplatelet medications (81 mg acetylsalicylic acid daily permitted), anticoagulants, thrombolytics or anti-inflammatory medications within 2 weeks of treatment.
• 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.
• 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).
• Use of medications, herbs, food supplements, and vitamins known to induce photosensitivity to light exposure at the wavelength used or history of photosensitivity disorder.
• 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.
• 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.
• History of keloid or hypertrophic scar formation or poor wound healing in the treatment area.
• As per the investigator's discretion, any physical or mental condition which may make it unsafe for the subject to participate.
• 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.

Where it is running

• Berman Skin Institute — Los Altos, California, United States
• Laser & Skin Surgery Medical Group, Inc — Sacramento, California, United States
• Batra Dermatology — Santa Monica, California, United States
• aFresh Medispa — Chicago, Illinois, United States
• UT Southwestern Medical Center Department of Plastic Surgery — Dallas, Texas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.