Clinical trial NCT03756168: Clinical Evaluation of the Safety and Efficacy of a 1060 nm Diode Laser (Flanks)
Official title: Clinical Evaluation of the Safety and Efficacy of a 1060 nm Diode Laser for Non-invasive Fat Reduction of the Flanks
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fat Atrophy
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: 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.

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.

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: Change in the Percentage of Fat Thickness From Baseline to 12-weeks Post-treatment
timeFrame: Week 12
Secondary outcomes:
measure: Change in Abdominal Circumference From Baseline to 12 Weeks Post-treatment
timeFrame: Week 12
measure: Subject Satisfaction
timeFrame: Week 12
measure: Treatment Pain
timeFrame: Day 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: UT Southwestern Medical Centre
state: Texas
Study officials:
affiliation: Skin and Laser Centre of Northern California
name: Suzanne Kilmer, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: UT Southwestern
name: Jeffery Kenkel, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.