Effects of Green Light Therapy on Body Contouring and Cellulite
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Ward Photonics LLC
- Enrollment
- 52
- Locations
- 8
- Primary Endpoint
- Average Change in Inches of Total Circumference Measurements
Study Overview
Brief Summary
A double-blind, placebo-controlled randomized evaluation of the effect of Cellulize, a green light low level laser system for aesthetic use for the non-invasive reduction in fat layer for body contouring and reduction of cellulite.
Detailed Description
This clinical trial will provide objective evidence showing effectiveness of the Cellulize 532nm green light therapy for the non-invasive reduction in fat layer for body contouring, and for the non-invasive treatment for the appearance of cellulite.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Care Provider)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Study participant between the ages of 18 and older.
- •Female only
- •Subject is willing and able to abstain from partaking in any treatment other than the study procedures (existing or new) to promote body contouring/circumference reduction/weight loss during the course of study participation.
- •Subject is willing and able to maintain his or her regular (typical pre-study) diet and exercise regimen without effecting significant change in either direction during study participation.
Exclusion Criteria
- •No photo-therapy (red or green) within 3 weeks of treatment.
- •Known cardiovascular disease such as cardiac arrhythmias, congestive heart failure.
- •Cardiac surgeries such as cardiac bypass, heart transplant surgery, pacemakers.
- •Prior surgical intervention for body sculpting/weight loss, such as liposuction, abdominoplasty, stomach stapling, lap band surgery, etc.
- •Medical, physical, or other contraindications for body sculpting/weight loss.
- •Current use of medication(s) known to affect weight levels/cause bloating or swelling and for which abstinence during the course of study participation is not safe or medically prudent.
- •Any medical condition known to affect weight levels and/or to cause bloating or swelling.
- •Active infection, open wound (e.g. sores, cuts, ulcers, burns, etc.) or other external trauma to the areas to be treated with the laser/lymphatic drainage system devices.
- •Photosensitive condition or medication.
- •Active cancer within the past year.
- •Pregnant, possibly pregnant or planning pregnancy prior to the end of study participation.
- •Diminished ability to void waste (liver or kidneys).
- •Developmental disability or cognitive impairment that in the opinion of the investigator would preclude adequate comprehension of the informed consent form and/or ability to record the necessary study measurements.
Arms & Interventions
Cellulize 532nm
Cellulize device using 532nm Green Light.
Cellulize Placebo (Sham Comparator)
Cellulize modified to appear as if it is running, but does not use the 532nm light.
"Sham" Device, or "Placebo."
Intervention: Sham Comparator (Device)
Outcomes
Primary Outcomes
Average Change in Inches of Total Circumference Measurements
Time Frame: 2 weeks
Average Change in Inches of Total Circumference Measurements for effect of Cellulize, a LED 532nm green light low level laser system for aesthetic use for the non-invasive reduction in fat layer for body contouring from baseline measurements, and after treatment.
Secondary Outcomes
- Change in appearance of cellulite(2 weeks)
- Durability of Effect(2 weeks)