Effects of Green Light Therapy on Body Contouring and Cellulite

NCT03647748 | Completed

• 1 other identifier: CP16-02
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 4

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.

Conditions

Fat Reduction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Durability of Effect

  2 weeks

• Change in appearance of cellulite

  2 weeks

Study Arms (2)

Cellulize 532nm

NO INTERVENTION

Cellulize device using 532nm Green Light.

Cellulize Placebo (Sham Comparator)

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

Interventions

Sham Comparator DEVICE

A modified device utilizing a pigtail connector to bypass active treatment.

Cellulize Placebo (Sham Comparator)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ward Photonics LLC: lead

Study Sites (4)

Wunderlich Chiropractic Clinic

Cape Coral, Florida, 33904, United States

Location

Mobile Laser Slimming

Cocoa Beach, Florida, 32931, United States

Location

Lake Mary Health and Wellness

Lake Mary, Florida, 32714, United States

Location

Michigan Center for Cosmetic Surgery, Ann Arbor, Michigan

Ann Arbor, Michigan, 48104, United States

Location

Study Officials

• Robert H Burke, MD

  Michigan Center for Cosmetic Surgery, Ann Arbor, Michigan

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 20, 2018
• First Posted: August 27, 2018
• Study Start: January 1, 2017
• Primary Completion: August 1, 2018
• Study Completion: August 1, 2018
• Last Updated: August 27, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)