CelluliteNCT01702259
Study of the Effect of Low Level Laser Light Therapy on Reducing the Appearance of Cellulite in the Thighs and Buttocks.
A study testing Erchonia Scanner device (GLS) in people with Cellulite, run by Erchonia Corporation at 2 sites in United States.
Trial summary
The purpose of this study is to determine whether the application of green diode low level laser light therapy is effective in reducing the appearance of cellulite in the thighs and buttocks. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cellulite
- What is being tested?
- Erchonia Scanner device (GLS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 68 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2009to Sep 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
- Willing and able to maintain regular diet and exercise regimen without effecting significant change in either direction during the study
- Willing and able to maintain regular medication schedule, as is medically feasible, during the study
Who cannot join
- Clinical cellulite gradation of Stage 0 or I on the Nurnberger Muller Scale (NMS) for either one or both thighs/buttocks
- P3 or P4 or P5 or P6 on the ASA Physical Status Classification System
- Weight fluctuation greater than 10 pounds in the prior month
- Previous attempt(s) to reduce cellulite in the study treatment areas over the past 6 months
- Prior surgical intervention to the treatment areas, for any reason
- Medical, physical or other contraindications for cellulite reduction/body contouring/weight loss
Show all 21Show fewer
- Current use of medication(s) known to affect weight levels and/or cause bloating or swelling and for which abstinence during the study is not safe or medically prudent
- Any medical condition known to affect weight levels, cause bloating or swelling
- Diagnosis of, and/or taking medication for, irritable bowel syndrome
- Active infection, wound or other external trauma to the study treatment areas
- Dermatitis or significant scarring in the study treatment areas
- Medical, physical, or other contraindications for, or known sensitivity to, light therapy
- Diabetes dependent on insulin or oral hypoglycemic medications
- Known cardiovascular disease
- Cardiac surgeries
- History of deep venous thrombosis, arterial disease of the legs
- Pregnant, breast feeding, or planning pregnancy prior to study end
- Serious mental health illness or psychiatric hospitalization in past 2 years
- Developmental disability or cognitive impairment that would impact study participation
- Involved in litigation/receiving disability benefits related to the parameters of the study
- Participation in research in the past 30 days
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Bloomfield Laser and Cosmetic Surgery Center
Bloomfield Hills, Michigan, 48302
Surgeon's Inc.
Marion, Indiana, 46952
About this study
Official title: 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.
The purpose of this study is to determine whether the application of green diode low level laser light therapy is effective in reducing the appearance of cellulite in the thighs and buttocks.
Read the detailed description
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.
- Conditions
- Cellulite
- Being tested
- Erchonia Scanner device (GLS), Placebo device
- Medical subject headings
- Cellulite
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erchonia Scanner device (GLS)Device
The Erchonia® GLS device is made up of six independent diodes, each emitting 17 milliwatts (mW), 532 nanometer (nm) of green laser light.
Placebo deviceDevice
Inactive Erchonia GLS.
| Study group | Role | What they receive |
|---|---|---|
| Erchonia Scanner device (GLS) | Experimental | The Erchonia® GLS device is made up of six independent diodes, each emitting 17 milliwatts (mW), 532 nanometer (nm) of green laser light. Receives: Device: Erchonia Scanner device (GLS) |
| Placebo device | Sham comparator | Inactive Erchonia GLS device Receives: Device: Placebo device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects That Met the Individual Success Criteria
The individual subject success was defined as a decrease of one or more stages on the Nurnberger-Muller Scale (NMS) from baseline to 2 weeks post-assessment for both of the right and left thighs. The NMS is a four-stage scale used as an industry standard to classify stage or degree of cellulite and to determine change in stage or degree of cellulite following treatment intervention. The NMS ranges from Stage 0 (no cellulite) to Stage III (worse cellulite). A decrease in NMS Stage indicates reduced appearance of cellulite and is positive for study success. An increase in NMS Stage indicates worsened appearance of cellulite and is negative for study success. Overall study success was defined as 35% more subjects in the test group than in the control group attaining individual subject success. Results are reported below as the number of subjects in each group that met the individual subject success criteria.
Measured: Baseline and 2 weeks
Secondary outcomes (4)
Bilateral Upper Thigh Circumference Measurement
Circumference of the upper right and left thighs was recorded in inches (ins) using a flexible tape measure and the two measurements were summed, at baseline and 2 weeks. A decrease in bilateral upper thigh circumference measurements is positive in support of study success and an increase in bilateral circumference measurements is negative in support of study success.
Measured: Baseline and 2 weeks
Change in Body Weight
Body weight is measured in pounds (lbs) using a digital scale.
Measured: Baseline and 2 weeks
Change in Percent (%) Body Surface Area (BSA) Covered by Cellulite.
The % Total Body Surface Area (% TBSA) covered by cellulite was marked and quantified according to the Lund and Browder Chart and methodology. The Lund and Browder chart is widely considered the most accurate method of determining Body Surface Area (BSA). It consists of an anterior and posterior diagram of a patient that is divided into sections. The % TBSA is the sum of the marked areas. The % TBSA of the buttocks and bilateral thighs area, front and back combined, affected by cellulite was calculated according to the Lund and Browder Chart.
Measured: Baseline and 2 weeks
Patient Satisfaction With Study Outcome
At completion of the treatment administration phase, the subject was asked to indicate how satisfied he or she was with any overall perceived change in the appearance of cellulite in his or her thighs and buttocks using the following five-point scale:
Very Satisfied Somewhat Satisfied Neither Satisfied nor Dissatisfied Not Very Satisfied Not at All Satisfied
Results are reported as the number of subjects who reported being 'Very Satisfied' or 'Somewhat Satisfied' with the study outcome.
Measured: 2 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2012 (estimated)
- Study startOct 2009
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for CelluliteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erchonia Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gregory C Roche, D.O., Principal investigatorRobert F Jackson, M.D., Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01702259
- Sponsor's protocol ID
- EMCTE002
- Status last verified
- Nov 2015
- First submitted
- 4 Oct 2012
- Last updated
- 11 Dec 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT01702259
- Acronym / sponsor ID
- EMCTE002
- Conditions
- Cellulite
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Erchonia CorporationIndustry (pharma, biotech, devices)
- Study start
- Oct 2009
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 8 Oct 2012 (estimated)
- Results
- Posted 11 Dec 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether the application of green diode low level laser light therapy is effective in reducing the appearance of cellulite in the thighs and buttocks.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Erchonia Scanner device (GLS) | Experimental | Device: Erchonia Scanner device (GLS)The Erchonia® GLS device is made up of six independent diodes, each emitting 17 milliwatts (mW), 532 nanometer (nm) of green laser light. |
| Placebo device | Sham comparator | Device: Placebo deviceInactive Erchonia GLS device |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
- Willing and able to maintain regular diet and exercise regimen without effecting significant change in either direction during the study
Key exclusion criteria (21 listed)
- Clinical cellulite gradation of Stage 0 or I on the Nurnberger Muller Scale (NMS) for either one or both thighs/buttocks
- P3 or P4 or P5 or P6 on the ASA Physical Status Classification System
- Weight fluctuation greater than 10 pounds in the prior month
- Previous attempt(s) to reduce cellulite in the study treatment areas over the past 6 months
- Prior surgical intervention to the treatment areas, for any reason
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Erchonia Scanner device (GLS)The Erchonia® GLS device is made up of six independent diodes, each emitting 17 milliwatts (mW), 532 nanometer (nm) of green laser light. | Device | Erchonia Scanner device (GLS) |
| Placebo deviceInactive Erchonia GLS. | Device | Placebo device |
Primary outcome
Number of Subjects That Met the Individual Success Criteria
Time frame: Baseline and 2 weeks
The individual subject success was defined as a decrease of one or more stages on the Nurnberger-Muller Scale (NMS) from baseline to 2 weeks post-assessment for both of the right and left thighs. The NMS is a four-stage scale used as an industry standard to classify stage or degree of cellulite and to determine change in stage or degree of cellulite following treatment intervention. The NMS ranges from Stage 0 (no cellulite) to Stage III (worse cellulite). A decrease in NMS Stage indicates reduced appearance of cellulite and is positive for study success. An increase in NMS Stage indicates worsened appearance of cellulite and is negative for study success. Overall study success was defined as 35% more subjects in the test group than in the control group attaining individual subject success. Results are reported below as the number of subjects in each group that met the individual subject success criteria.
4 secondary outcomes
Bilateral Upper Thigh Circumference Measurement
Time frame: Baseline and 2 weeks
Change in Body Weight
Time frame: Baseline and 2 weeks
Change in Percent (%) Body Surface Area (BSA) Covered by Cellulite.
Time frame: Baseline and 2 weeks
Patient Satisfaction With Study Outcome
Time frame: 2 Weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gregory C Roche, D.O. principal investigator
Robert F Jackson, M.D. principal investigator
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Erchonia Scanner device (GLS) in people with Cellulite, run by Erchonia Corporation at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Dec 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Subjects That Met the Individual Success Criteria (time frame: Baseline and 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2015.