Effects of Green Light Therapy on Body Contouring and Cellulite (Cellulize)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03647748|
Recruitment Status : Completed
First Posted : August 27, 2018
Last Update Posted : August 27, 2018
|Condition or disease||Intervention/treatment||Phase|
|Fat Reduction||Device: Sham Comparator||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||52 participants|
|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)|
|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|
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.
- 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.
- 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.
- 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.
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
|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|
|Study Director:||Robert H Burke, MD||Michigan Center for Cosmetic Surgery, Ann Arbor, Michigan|