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

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ClinicalTrials.gov Identifier: NCT03647748
Recruitment Status : Completed
First Posted : August 27, 2018
Last Update Posted : August 27, 2018
Sponsor:
Information provided by (Responsible Party):
Ward Photonics LLC

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.

Condition or disease Intervention/treatment Phase
Fat Reduction Device: Sham Comparator Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Effects of Green Light Therapy on Body Contouring and Cellulite
Actual Study Start Date : January 2017
Actual Primary Completion Date : August 2018
Actual Study Completion Date : August 2018

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.




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Durability of Effect [ Time Frame: 2 weeks ]
    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. Change in appearance of cellulite [ Time Frame: 2 weeks ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03647748


Locations
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United States, Florida
Wunderlich Chiropractic Clinic
Cape Coral, Florida, United States, 33904
Mobile Laser Slimming
Cocoa Beach, Florida, United States, 32931
Lake Mary Health and Wellness
Lake Mary, Florida, United States, 32714
United States, Michigan
Michigan Center for Cosmetic Surgery, Ann Arbor, Michigan
Ann Arbor, Michigan, United States, 48104
Sponsors and Collaborators
Ward Photonics LLC
Investigators
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Study Director: Robert H Burke, MD Michigan Center for Cosmetic Surgery, Ann Arbor, Michigan

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Responsible Party: Ward Photonics LLC
ClinicalTrials.gov Identifier: NCT03647748     History of Changes
Other Study ID Numbers: CP16-02
First Posted: August 27, 2018    Key Record Dates
Last Update Posted: August 27, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Cellulite
Skin Manifestations
Signs and Symptoms