Clinical Evaluation of the Safety and Efficacy of a 1060 nm Diode Laser (Flanks)
- Conditions
- Fat Atrophy
- Registration Number
- NCT03756168
- Lead Sponsor
- Venus Concept
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Change in the Percentage of Fat Thickness From Baseline to 12-weeks Post-treatment Week 12 Change in the percentage of fat thickness of the adipose layer as measured by ultrasound at 12 weeks post-treatment as compared to baseline.
- Secondary Outcome Measures
Name Time Method Change in Abdominal Circumference From Baseline to 12 Weeks Post-treatment Week 12 Change in the abdominal circumference at 12 weeks post-treatment as compared to baseline
Subject Satisfaction Week 12 Subject satisfaction with treatment at 12 weeks was assessed using the 5-point Likert subject satisfaction scale. 5 is very satisfied, while 1 is very unsatisfied
Treatment Pain Day 1 Treatment pain assessed immediately post-treatment as measured using the Wong-Baker Faces Scale. Pain was measured on a scale from 0-10 (10 worst pain ever, to 0 no pain at all)
Trial Locations
- Locations (2)
Laser and Skin Surgery Center of Northern California
🇺🇸Sacramento, California, United States
UT Southwestern Medical Centre
🇺🇸Dallas, Texas, United States
Laser and Skin Surgery Center of Northern California🇺🇸Sacramento, California, United States