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

• ClinicalTrials.gov Identifier: NCT03756350
• Recruitment Status: Completed
• First Posted: November 28, 2018
• Last Update Posted: October 30, 2020
• Sponsor: Venus Concept
• Information provided by (Responsible Party): Venus Concept

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Fat Atrophy	Device: 1060nm diode laser	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 30 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Masking Description: Blinded reviewer will evaluate the pre and post photos
• Primary Purpose: Treatment
• Official Title: Clinical Evaluation of the Safety and Efficacy of a 1060nm Diode Laser for Non-invasive Fat Reduction of the Abdomen
• Actual Study Start Date: November 14, 2018
• Actual Primary Completion Date: July 2, 2019
• Actual Study Completion Date: July 2, 2019

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. Photographic evaluation [ Time Frame: week 12 ]
   Photographic evaluation by indepependant blinded reviewers with correct identification of pre-treatment baseline images when compared to post-treatment images taken at twelve weeks

Secondary Outcome Measures :

1. Fat thickness [ Time Frame: week 12 ]
   to determine the change in thickness of the adipose layer as measured by ultrasound at 12 weeks post treatment as compared to baseline
2. Change in Abdominal circumference [ Time Frame: week 12 ]
   to determine the change in the abdominal circumference at 12 weeks post treatment as compare to baseline
3. Subject satisfaction [ Time Frame: week 12 ]
   to assess subject satisfaction with treatment at 12 weeks using the 5 point Likert subject satisfaction scale. 5 being very satisfied and 1 being very unsatisfied
4. Incidence of Treatment-Emergent Adverse Events [ Time Frame: week 12 ]
   Subjects experiencing a treatment related adverse event
5. Comfort [ Time Frame: week 1 ]
   Subject assessment of discomfort and pain post treatment as measured by the Wong Baker Faces Scale. 10 point scale with 10 being the worst pain ever and 0 being no pain

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Locations

United States, California

Laser and Skin Surgery Center of Northern California

Sacramento, California, United States, 95816

United States, Texas

Southwestern Medical Center Department of Plastic Surgery

Dallas, Texas, United States, 75390

Sponsors and Collaborators

Venus Concept

Investigators

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

More Information

Publications of Results:

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.

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. Review.

• Responsible Party: Venus Concept
• ClinicalTrials.gov Identifier: NCT03756350
• Other Study ID Numbers: CS1317
• First Posted: November 28, 2018
• Last Update Posted: October 30, 2020
• Last Verified: October 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes

Keywords provided by Venus Concept:

abdomen; adipose; fat

Additional relevant MeSH terms:

Atrophy; Pathological Conditions, Anatomical