Clinical trial NCT03647748: Effects of Green Light Therapy on Body Contouring and Cellulite
Official title: Effects of Green Light Therapy on Body Contouring and Cellulite
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fat Reduction
Lead sponsor: Ward Photonics LLC
Sponsor class: INDUSTRY
First posted: 2018-08-27
Enrollment: 52
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Average Change in Inches of Total Circumference Measurements
timeFrame: 2 weeks
Secondary outcomes:
measure: Durability of Effect
timeFrame: 2 weeks
measure: Change in appearance of cellulite
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Cape Coral
country: United States
facility: Wunderlich Chiropractic Clinic
state: Florida
city: Cocoa Beach
country: United States
facility: Mobile Laser Slimming
state: Florida
city: Lake Mary
country: United States
facility: Lake Mary Health and Wellness
state: Florida
city: Ann Arbor
country: United States
facility: Michigan Center for Cosmetic Surgery, Ann Arbor, Michigan
state: Michigan
Study officials:
affiliation: Michigan Center for Cosmetic Surgery, Ann Arbor, Michigan
name: Robert H Burke, MD
role: STUDY_DIRECTOR
References: