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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
All subjects received a single treatment with Venus Bliss' 1064 nm laser administered to the flanks Venus Bliss is a non-invasive medical aesthetic device designed for body contouring. The device contains four 1060 nm diode laser applicators which are 60x60 mm in size. It has a separate RF/PEMF applicator, but this was not used in this study. There is a belt included with the system to allow for the secure attachment of the applicators to the treatment area.
Laser and Skin Surgery Center of Northern California
Sacramento, California, United States
UT Southwestern Medical Centre
Dallas, Texas, United States
Change in the Percentage of Fat Thickness From Baseline to 12-weeks Post-treatment
Change in the percentage of fat thickness of the adipose layer as measured by ultrasound at 12 weeks post-treatment as compared to baseline.
Time frame: Week 12
Change in Abdominal Circumference From Baseline to 12 Weeks Post-treatment
Change in the abdominal circumference at 12 weeks post-treatment as compared to baseline
Time frame: Week 12
Subject Satisfaction
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
Time frame: Week 12
Treatment Pain
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)
Time frame: Day 1
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