Effects of Green Light Therapy on Body Contouring and Cellulite

NCT ID: NCT03647748

Last Updated: 2018-08-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-31
• Study Completion Date: 2018-08-31

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.

Conditions

Fat Reduction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Cellulize 532nm

Cellulize device using 532nm Green Light.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Cellulize Placebo (Sham Comparator)

Cellulize modified to appear as if it is running, but does not use the 532nm light.

"Sham" Device, or "Placebo."

Group Type: SHAM_COMPARATOR

Sham Comparator

Intervention Type: DEVICE

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

Interventions

Sham Comparator

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

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Ward Photonics LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert H Burke, MD

Role: STUDY_DIRECTOR

Michigan Center for Cosmetic Surgery, Ann Arbor, Michigan

Locations

Wunderlich Chiropractic Clinic

Cape Coral, Florida, United States

Mobile Laser Slimming

Cocoa Beach, Florida, United States

Lake Mary Health and Wellness

Lake Mary, Florida, United States

Michigan Center for Cosmetic Surgery, Ann Arbor, Michigan

Ann Arbor, Michigan, United States

Countries

United States

Other Identifiers

CP16-02

Identifier Type: -

Identifier Source: org_study_id