Completed

A Double-Blind, Placebo-Controlled Randomized Evaluation of the Effect of the Erchonia Scanner Device (GLS) Green Diode on Reducing the Appearance of Cellulite Clinical Study Protocol.

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What is being tested

Erchonia Scanner device (GLS)

+ Placebo device

Device
Who is being recruted

Signs and Symptoms+1

+ Skin Manifestations

+ Pathological Conditions, Signs and Symptoms

From 18 to 55 Years
+27 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-Controlled
Interventional
Study Start: October 2009
See protocol details

Summary

Principal SponsorErchonia Corporation
Last updated: December 11, 2015
Sourced from a government-validated database.Claim as a partner

Study start date: October 1, 2009

Actual date on which the first participant was enrolled.

Cellulite is a common term used to describe superficial pockets of trapped fat, which causes uneven dimpling or "orange peel" skin. It appears in 90% of post-adolescent women. In advanced stages of cellulite, heaviness and pain may occur. Currently available treatments for cellulite have minimal to no demonstrable effect and some involve risky invasive procedures. Therefore, the potential advantages of the application of low level laser light therapy to reduce the appearance of cellulite over current treatment options include a risk free procedure that is non-invasive and pain free. Since low level laser light within the green spectrum has been proven to increase the synthesis of collagen, it is believed that its application may serve to decrease the appearance of cellulite by tightening the skin. Moreover, newly synthesized collagen may alter the irregular pattern of the connective tissue responsible for the formation of cellulite.

NCT01702259
Principal SponsorErchonia Corporation
Last updated: December 11, 2015
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

68 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

From 18 to 55 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Signs and SymptomsSkin ManifestationsPathological Conditions, Signs and SymptomsCellulite

Criteria

6 inclusion criteria required to participate
Areas for which cellulite appearance reduction is being sought are the bilateral thighs and buttocks
Clinical cellulite gradation of Stage II or III on the Nurnberger-Muller scale for each treatment area
PI or P2 on the American Society of Anesthesiologists (ASA) Physical Status Classification System
Willing and able to abstain from partaking in any treatment other than the study procedure to promote cellulite appearance reduction/body contouring/weight loss during the study
Show More Criteria
21 exclusion criteria prevent from participating
Active infection, wound or other external trauma to the study treatment areas
Any medical condition known to affect weight levels, cause bloating or swelling
Cardiac surgeries
Clinical cellulite gradation of Stage 0 or I on the Nurnberger Muller Scale (NMS) for either one or both thighs/buttocks
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
The Erchonia® GLS device is made up of six independent diodes, each emitting 17 milliwatts (mW), 532 nanometer (nm) of green laser light.

Group II

Sham
Inactive Erchonia GLS device

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

Surgeon's Inc.

Marion, United StatesOpen Surgeon's Inc. in Google Maps

Bloomfield Laser and Cosmetic Surgery Center

Bloomfield Hills, United States
Completed2 Study Centers