Clinical Evaluation of the Safety and Efficacy of a 1060 nm Diode Laser (Flanks)

Clinical Evaluation of the Safety and Efficacy of a 1060 nm Diode Laser for Non-invasive Fat Reduction of the Flanks

The objective of this clinical study is to assess the safety and efficacy of using a 1060 nm diode laser for non-invasive fat reduction of the flanks.

Study Overview

• Status: Completed
• Conditions: Fat Atrophy
• Intervention / Treatment: Device: 1060nm Diode laser

Detailed Description

Open-label, baseline-controlled, evaluator-blind, multi-center study evaluating a 1060 nm diode laser for non-invasive fat reduction of the flanks. The study will enroll up to 50 subjects requesting non-invasive lipolysis of the flanks. Each subject will receive a single study treatment. Subjects will be followed at six weeks and twelve weeks post-treatment. Twelve week outcome will be compared to baseline.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Sacramento, California, United States, 95816
      • Laser and Skin Surgery Center of Northern California
  • Texas
    • Dallas, Texas, United States, 75390
      • UT SOUTHWESTERN medical CENTRE

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• able to read, understand and voluntarily provide written informed consent
• healthy male or female > 18 years of age seeking treatment for unwanted fat in the abdomen
• BMI score is less then 30
• 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 enrolment and for the duration of the study, have a negative urine pregnancy test baseline

Exclusion Criteria:

• 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 month prior to and during the course of the study
• History of hyperlipidemia, diabetes, hepatitis, blood coagulopathy or excessive bleeding
• Use of antiplatelet medications (81 mg of acetylsalicylic acid daily is permitted), anticoagulants, thrombocytes or any-inflammatory medications within 2 weeks of treatment
• Having a history of skin cancer or any other cancer in the area to be treated, including presence of malignant or pre-malignant pigmented lesions
• Having a permanent implant in the treatment area such as a metal plate or injected chemical substance such as silicone pr parenteral gold therapy (gold sodium thiomalate)
• Use of medications, herbs or food supplements and vitamins known to induce photosensitivity to light exposure at the wavelength used 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
• Poor quality skin (laxity)
• Abdominal wall, muscular abnormality or hernia on physical examination
• Unstable weight within the last 6 months (+ or - 3% weight change in the prior six months)
• Participation in another clinical study involving the same anatomical areas within the last 6 months
• History of keloid and hypertrophic scar formation or poor wound healing in the treatment area
• As per the investigators discretion any physician or mental condition which may make it unsafe for the subject to participate

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: All subjects

Device: 1060nm Diode laser; All subjects received a single treatment with Venus Bliss' 1064 nm laser administered to the flanks Venus Bliss is a non-invasive medical aesthetic device designed for body contouring. The device contains four 1060 nm diode laser applicators which are 60x60 mm in size. It has a separate RF/PEMF applicator, but this was not used in this study. There is a belt included with the system to allow for the secure attachment of the applicators to the treatment area.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the Percentage of Fat Thickness From Baseline to 12-weeks Post-treatment	Change in the percentage of fat thickness of the adipose layer as measured by ultrasound at 12 weeks post-treatment as compared to baseline.	Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Abdominal Circumference From Baseline to 12 Weeks Post-treatment	Change in the abdominal circumference at 12 weeks post-treatment as compared to baseline	Week 12
Subject Satisfaction	Subject satisfaction with treatment at 12 weeks was assessed using the 5-point Likert subject satisfaction scale. 5 is very satisfied, while 1 is very unsatisfied	Week 12
Treatment Pain	Treatment pain assessed immediately post-treatment as measured using the Wong-Baker Faces Scale. Pain was measured on a scale from 0-10 (10 worst pain ever, to 0 no pain at all)	Day 1

Collaborators and Investigators

• Sponsor: Venus Concept
• Investigators: Principal Investigator: Suzanne Kilmer, MD, Skin and Laser Centre of Northern California; Principal Investigator: Jeffery Kenkel, MD, UT Southwestern

Publications and helpful links

General Publications

• Kang A, Kislevitz M, Wamsley C, Barillas J, Hoopman J, Kenkel J, Kilmer S. Clinical evaluation of the safety and efficacy of a 1060 nm diode laser for non-invasive fat reduction of the flanks. J Cosmet Dermatol. 2023 Nov;22(11):3017-3025. doi: 10.1111/jocd.15954. Epub 2023 Aug 22.

Study record dates

Study Major Dates

• Study Start (Actual): November 14, 2018
• Primary Completion (Actual): July 2, 2019
• Study Completion (Actual): July 2, 2019

Study Registration Dates

• First Submitted: November 26, 2018
• First Submitted That Met QC Criteria: November 27, 2018
• First Posted (Actual): November 28, 2018

Study Record Updates

• Last Update Posted (Actual): January 30, 2024
• Last Update Submitted That Met QC Criteria: January 24, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Atrophy
• Other Study ID Numbers: CS0518

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes