Multi-center, three-arm, randomized, evaluator-blinded study of electrical muscle stimulation (EMS) and/or 1064 nm diode laser, pulsed electromagnetic field (PEMF) and vacuum assisted radio frequency (RF) using the Venus Bliss Max for fat reduction, body contouring and aesthetic improvement.
The study will enroll up to 60 male and female subjects, ≥ 18 years of age, requesting non-invasive electrical muscle stimulation (EMS) and/or lipolysis of the abdomen and flanks. Subjects will be randomized to one of three arms as per randomization scheme. This study will have 3 Arms at a ratio of 2:1:1 (A:B:C): Arm A: Full Treatment Arm (Laser + EMS + RF/PEMF) Arm B: EMS/RF Arm (EMS + RF/PEMF) Arm C: EMS Arm (EMS only) Arm A: Three (3) diode laser treatments treatments at days 0, 28 and 56 (±2 days). Subjects will also receive bi-weekly electrical muscle stimulation and pulsed electromagnetic fields (PEMF)/vacuum assisted radio frequency (RF) treatments at days 0, 14, 28, 42 and 56 (±2 days). Arm B: Subjects will receive bi-weekly electrical muscle stimulation and pulsed electromagnetic fields/vacuum assisted radio frequency treatments at days 0, 14, 28, 42 and 56 (±2 days). Arm C: Subjects will receive weekly electrical muscle stimulation treatments at days 0, 7, 14, 21, 28 and 35 (±2 days). Subjects in Arms A and B will be followed at 84 and 140 days (±7 days) after their last treatment. Subjects in Arm C will be followed at 63 and 119 days (±7 days) after their last treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
36
Abdominal muscle stimulation using EMS
Adipose tissue heating using 1064 nm diode laser
Collagen re-modelling and reduction in subcutaneous fat using RF/PEMF
Scripps Clinical Research - General Medicine
San Diego, California, United States
Schweiger Dermatology Group
Hackensack, New Jersey, United States
Tennessee Clinical Research Center
Nashville, Tennessee, United States
Blinded, independent photo review comparing the pre-treatment and post-treatment photographs.
Physician board-certified dermatologist to evaluate contour improvement per the Global Aesthetic Improvement Scale (GAIS), with scores in order of 'most improved' to 'worse': Most improved (score of 5); Much improved (score of 4); Improved (score of 3); No change (score of 2); Worse (score of 1).
Time frame: 140 days (Arms A & B); 119 days (Arm C)
Blinded Investigator review comparing the pre-treatment photographs and post-treatment Follow-up live assessment.
Primary Investigator to evaluate live contour improvement compared to pre-treatment photographs per the Global Aesthetic Improvement Scale (GAIS), with scores in order of 'most improved' to 'worse': Most improved (score of 5); Much improved (score of 4); Improved (score of 3); No change (score of 2); Worse (score of 1).
Time frame: Follow-up 1: 84 days (Arm A & B); 63 days (Arm C). Follow-up 2: 140 days (Arms A & B); 119 days (Arm C)
Change in the subject Body Satisfaction Questionnaire (BSQ)
Subject self evaluation of the BSQ post treatment compared to Baseline with a possible score of: 5 (Very Satisfied); 4 (Satisfied); 3 (Neither Satisfied or Dissatisfied); 2 (Dissatisfied); and 1 (Very Dissatisfied).
Time frame: Follow-up 1: 84 days (Arm A & B); 63 days (Arm C). Follow-up 2: 140 days (Arms A & B); 119 days (Arm C)
Change in Anthropometric measurements: Abdominal Circumference
Pre- and post-treatment circumference (centimeters) changes made at Treatments 1 \& 3 (Arm A \& B) and Treatments 1 \& 5 (Arm C). Follow-up visit circumference (centimeters) made at 1 and 3 months post treatment compared to baseline (All Arms).
Time frame: Treatment 1 and 3; Day 0 and Day 28 (Arm A and B). Treatment 1 and 5; Day 0 and Day 28 (Arm C). Follow-up 1: 84 days (Arm A & B); 63 days (Arm C). Follow-up 2: 140 days (Arms A & B); 119 days (Arm C)
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Change in Anthropometric measurements: Abdominal Skinfold Thickness
Pre- and post-treatment abdominal skinfold thickness (millimeters) changes made at Treatment 1. Follow-up visit abdominal skinfold thickness (millimeters) changes made at one and three months post-treatment compared to baseline (All Arms).
Time frame: Treatment 1; Day 0 (All Arms). Follow-up 1: 84 days (Arm A & B); 63 days (Arm C). Follow-up 2: 140 days (Arms A & B); 119 days (Arm C)
Change in Anthropometric measurements: Weight
Pre- and post-treatment weight measurement (kg/lbs) changes made at Treatment 1. Follow-up visit weight measurement (kg/lbs) changes made at one and three months post-treatment compared to baseline (All Arms).
Time frame: Treatment 1; Day 0 (All Arms). Follow-up 1: 84 days (Arm A & B); 63 days (Arm C). Follow-up 2: 140 days (Arms A & B); 119 days (Arm C)