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

Fat Atrophy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03756350
• Other study ID #: CS1317
• Status: Completed
• Phase: N/A
• Start date: November 14, 2018
• Est. completion date: July 2, 2019

Study information

• Verified date: May 2023
• Source: Venus Concept
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: July 2, 2019
• Est. primary completion date: July 2, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrophy
• Fat Atrophy

Intervention

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.

Locations

Country	Name	City	State
United States	Southwestern Medical Center Department of Plastic Surgery	Dallas	Texas
United States	Laser and Skin Surgery Center of Northern California	Sacramento	California

Sponsors (1)

Lead Sponsor	Collaborator
Venus Concept

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View Citation

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. — View Citation

McBean JC, Katz BE. Laser lipolysis: an update. J Clin Aesthet Dermatol. 2011 Jul;4(7):25-34. No abstract available. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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