Clinical trial NCT03756350: Clinical Evaluation of the Safety and Efficacy of a 1060nm Diode Laser (Abdomen)
Official title: Clinical Evaluation of the Safety and Efficacy of a 1060nm Diode Laser for Non-invasive Fat Reduction of the Abdomen
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fat Atrophy
Keywords: abdomen
adipose
fat
Lead sponsor: Venus Concept
Sponsor class: INDUSTRY
First posted: 2018-11-28
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Number of Before and After Photograph Sets Correctly Identified by Independent, Blinded Evaluators
timeFrame: Week 12 vs baseline
Secondary outcomes:
measure: Change in Fat Thickness
timeFrame: week 12
measure: Subject Satisfaction
timeFrame: Week 12
measure: Treatment Pain
timeFrame: Week 1
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: Laser and Skin Surgery Center of Northern California
state: California
city: Dallas
country: United States
facility: Southwestern Medical Center Department of Plastic Surgery
state: Texas
Study officials:
affiliation: Skin and Laser Surgery Center of Northern California
name: Suzanne Kilmer, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: UT Southwestern
name: Jeffery Kenkel, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
citation: McBean JC, Katz BE. Laser lipolysis: an update. J Clin Aesthet Dermatol. 2011 Jul;4(7):25-34. No abstract available.
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.