Clinical trial NCT04012814: Clinical Evaluation of a 1060 nm Diode Laser, PEMF and Vacuum Assisted MP RF for Non-invasive Fat Reduction
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adipose Tissue Atrophy
Keywords: fat
abdomen fat
flank fat
body contouring
Lead sponsor: Venus Concept
Sponsor class: INDUSTRY
First posted: 2019-07-09
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Up to 200 subjects will be enrolled in the study to receive 3 Diode and 3 RF treatments.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility 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.

Primary outcomes:
measure: Change in Aesthetic Appearance From Baseline
timeFrame: Week 24
Secondary outcomes:
measure: Subject Satisfaction: 5-Point Likert Subject Satisfaction Scale
timeFrame: Week 24
measure: Change in Fat Thickness
timeFrame: Week 24
Other outcomes:
Locations:
city: Los Altos
country: United States
facility: Berman Skin Institute
state: California
city: Sacramento
country: United States
facility: Laser & Skin Surgery Medical Group, Inc
state: California
city: Santa Monica
country: United States
facility: Batra Dermatology
state: California
city: Chicago
country: United States
facility: aFresh Medispa
state: Illinois
city: Dallas
country: United States
facility: UT Southwestern Medical Center Department of Plastic Surgery
state: Texas
Study officials:
affiliation: Venus Concept LTD
name: Yoni Iger, PhD
role: STUDY_DIRECTOR
References: