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

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

This study is evaluating a 1060nm diode laser for non-invasive fat reduction of the abdomen. The study will enrolled up to 50 subjects requesting non-invasive lipolysis of the abdomen. Each subject will receive a single study treatment. Subjects will be followed at six and twelve weeks post treatment. Twelve week outcomes will be compared to baseline.

Study Overview

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

Detailed Description

Open-label baseline controlled evaluator-blind multi-centre study evaluating a 1060nm diode laser for non-invasive fat reduction of the abdomen. The study will enrolled up to 50 subjects requesting non-invasive lipolysis of the abdomen. Each subject will receive a single study treatment which takes approximately 25 minutes. Subjects will be followed at six and twelve weeks post treatment. Twelve week outcomes 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
      • Southwestern Medical Center Department of Plastic Surgery

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: Treatment subjects; Single group of subjects which will have the treatment of a 1060nm diode laser administered to them.	Device: 1060nm diode laser; Non-invasive medical aesthetic device designed for body contouring. The device is comprised of a console, four 1060nm diode laser applicators which are 60x60 mm in size. There is a belt included with the system to allow for the secure application of the applicators to the treatment area.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Before and After Photograph Sets Correctly Identified by Independent, Blinded Evaluators	Photographic evaluation by independent blinded evaluators with correct identification of pre-treatment baseline images when compared to post-treatment images taken at 12 weeks	Week 12 vs baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Fat Thickness	Change in thickness of the adipose layer as measured by ultrasound at 12 weeks post-treatment as compared to baseline	week 12
Subject Satisfaction	Subject satisfaction with treatment at 12 weeks after treatment using the 5-point Likert Subject Satisfaction Scale. A score of 4 is very satisfied and 0 is very unsatisfied.	Week 12
Treatment Pain	Subject assessment of discomfort and pain post treatment as measured using the Wong Baker Faces Scale, which is a 10 point scale with 10 being the worst pain ever and 0 being no pain.	Week 1

Collaborators and Investigators

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

Publications and helpful links

General Publications

• Decorato JW, Chen B, Sierra R. Subcutaneous adipose tissue response to a non-invasive hyperthermic treatment using a 1,060 nm laser. Lasers Surg Med. 2017 Jul;49(5):480-489. doi: 10.1002/lsm.22625. Epub 2017 Jan 19.
• Katz B, Doherty S. Safety and Efficacy of a Noninvasive 1,060-nm Diode Laser for Fat Reduction of the Flanks. Dermatol Surg. 2018 Mar;44(3):388-396. doi: 10.1097/DSS.0000000000001298.
• McBean JC, Katz BE. Laser lipolysis: an update. J Clin Aesthet Dermatol. 2011 Jul;4(7):25-34. No abstract available.
• Schilling L, Saedi N, Weiss R. 1060 nm Diode Hyperthermic Laser Lipolysis:The Latest in Non-Invasive Body Contouring. J Drugs Dermatol. 2017 Jan 1;16(1):48-52.

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 26, 2018
• First Posted (Actual): November 28, 2018

Study Record Updates

• Last Update Posted (Actual): July 3, 2023
• Last Update Submitted That Met QC Criteria: June 12, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: fat; abdomen; adipose
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Atrophy
• Other Study ID Numbers: CS1317

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