Effects of Green Light Therapy on Body Contouring and Cellulite (Cellulize)

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.

Study Overview

• Status: Completed
• Conditions: Fat Reduction
• Intervention / Treatment: Device: Sham Comparator

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 Type: Interventional
• Enrollment (Actual): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Cape Coral, Florida, United States, 33904
      • Wunderlich Chiropractic Clinic
    • Cocoa Beach, Florida, United States, 32931
      • Mobile Laser Slimming
    • Lake Mary, Florida, United States, 32714
      • Lake Mary Health and Wellness
  • Michigan
    • Ann Arbor, Michigan, United States, 48104
      • Michigan Center for Cosmetic Surgery, Ann Arbor, Michigan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Cellulize 532nm; Cellulize device using 532nm Green Light.
Sham Comparator: Cellulize Placebo (Sham Comparator); Cellulize modified to appear as if it is running, but does not use the 532nm light. "Sham" Device, or "Placebo."	Device: Sham Comparator; A modified device utilizing a pigtail connector to bypass active treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average Change in Inches of Total Circumference Measurements	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.	2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Durability of Effect	Durability of Effect: a term used to indicate whether the results of the primary outcome endure at the 2 week follow up time point. If the average change in inches of total circumference continues decreasing or stays the same, then the durability of effect is assumed to endure for at least two weeks. If the measurements at the 2-week time point show that the changes in inches return to previous measures at the start of treatment, then the effect is considered temporary.	2 weeks
Change in appearance of cellulite	Change in appearance of cellulite is a measure of the Nurnberger-Muller Scale (NMS) from baseline to 2 weeks post-assessment for both of the right and left thighs.	2 weeks

Collaborators and Investigators

• Sponsor: Ward Photonics LLC
• Investigators: Study Director: Robert H Burke, MD, Michigan Center for Cosmetic Surgery, Ann Arbor, Michigan

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): August 1, 2018
• Study Completion (Actual): August 1, 2018

Study Registration Dates

• First Submitted: August 20, 2018
• First Submitted That Met QC Criteria: August 23, 2018
• First Posted (Actual): August 27, 2018

Study Record Updates

• Last Update Posted (Actual): August 27, 2018
• Last Update Submitted That Met QC Criteria: August 23, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Manifestations; Cellulite
• Other Study ID Numbers: CP16-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No