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

Primary Purpose

Fat Reduction

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sham Comparator
Sponsored by
Ward Photonics LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fat Reduction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Wunderlich Chiropractic Clinic
  • Mobile Laser Slimming
  • Lake Mary Health and Wellness
  • Michigan Center for Cosmetic Surgery, Ann Arbor, Michigan

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Sham Comparator

Arm Label

Cellulize 532nm

Cellulize Placebo (Sham Comparator)

Arm Description

Cellulize device using 532nm Green Light.

Cellulize modified to appear as if it is running, but does not use the 532nm light. "Sham" Device, or "Placebo."

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
August 20, 2018
Last Updated
August 23, 2018
Sponsor
Ward Photonics LLC
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1. Study Identification

Unique Protocol Identification Number
NCT03647748
Brief Title
Effects of Green Light Therapy on Body Contouring and Cellulite
Acronym
Cellulize
Official Title
Effects of Green Light Therapy on Body Contouring and Cellulite
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
January 2017 (Actual)
Primary Completion Date
August 2018 (Actual)
Study Completion Date
August 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ward Photonics LLC

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fat Reduction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Patients randomly assigned to either the active 532nm treatment group, or the sham device (placebo) group using a modified device rigged to not treat patients.
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cellulize 532nm
Arm Type
No Intervention
Arm Description
Cellulize device using 532nm Green Light.
Arm Title
Cellulize Placebo (Sham Comparator)
Arm Type
Sham Comparator
Arm Description
Cellulize modified to appear as if it is running, but does not use the 532nm light. "Sham" Device, or "Placebo."
Intervention Type
Device
Intervention Name(s)
Sham Comparator
Intervention Description
A modified device utilizing a pigtail connector to bypass active treatment.
Primary Outcome Measure Information:
Title
Average Change in Inches of Total Circumference Measurements
Description
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.
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Durability of Effect
Description
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.
Time Frame
2 weeks
Title
Change in appearance of cellulite
Description
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.
Time Frame
2 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert H Burke, MD
Organizational Affiliation
Michigan Center for Cosmetic Surgery, Ann Arbor, Michigan
Official's Role
Study Director
Facility Information:
Facility Name
Wunderlich Chiropractic Clinic
City
Cape Coral
State/Province
Florida
ZIP/Postal Code
33904
Country
United States
Facility Name
Mobile Laser Slimming
City
Cocoa Beach
State/Province
Florida
ZIP/Postal Code
32931
Country
United States
Facility Name
Lake Mary Health and Wellness
City
Lake Mary
State/Province
Florida
ZIP/Postal Code
32714
Country
United States
Facility Name
Michigan Center for Cosmetic Surgery, Ann Arbor, Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48104
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Effects of Green Light Therapy on Body Contouring and Cellulite

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