Body ContouringNCT01376037
Efficacy Study of the Effect of Low Level Laser Light Therapy on Reducing Upper Arm Circumference
A study testing Erchonia(r) ML Scanner (MLS) in people with Body Contouring, run by Erchonia Corporation.
Trial summary
The purpose of this study is to determine if the Erchonia® ML Scanner (MLS) low level light laser device can help to reduce the circumference of the upper arms. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Body Contouring
- What is being tested?
- Erchonia(r) ML Scanner (MLS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 62 participants
- Where
- No sites listed yet
- Study dates
- Mar 2011to Jan 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject indicated for liposuction, or use of liposuction techniques, for the removal of localized deposits of adipose tissues that do not respond to diet and exercise; specifically for the indication of body contouring of the bilateral upper arms (As per the American Academy of Cosmetic Surgery's 2006 Guidelines for Liposuction Surgery developed by A joint Ad Hoc Committee of the American Society of Liposuction Surgery (ASLSS) and the American Academy of Cosmetic Surgery (AACS)), and/or for the procedure of brachioplasty (upper arm lift).
- Body Mass Index (BMI) of 20 to 35 kg/m².
- Subject is willing and able to abstain from partaking in any treatment other than the study procedure to promote body contouring and/or weight loss during study participation.
- Subject is willing and able to maintain his or her regular (typical pre-study procedure) diet and exercise regimen without effecting significant change in either direction during study participation.
Who cannot join
- Subject is seeking upper arm body contouring as a means of weight loss.
- Diabetes dependent on insulin or oral hypoglycemic medications.
- 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 of the arms, such as liposuction or brachioplasty.
- Prior surgical intervention for weight loss, such as stomach stapling, lap band surgery.
Show all 18Show fewer
- Medical, physical, or other contraindications for body sculpting/weight loss.
- Current use of medication(s) known to affect weight levels and/or to 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.
- Mastectomy or operations in the axilla lymph nodes.
- Active infection, wound or other external trauma to the areas to be treated with the laser.
- Pregnant, breast feeding, or planning pregnancy prior to the end of study participation.
- Serious mental health illness such as Alzheimer's, schizophrenia and bipolar disorder; psychiatric hospitalization in past two years.
- Developmental disability or cognitive impairment that in the professional judgment of the study Principal Investigator (PI) would preclude adequate comprehension of the informed consent form and/or ability to record the necessary study measurements.
- Photosensitivity disorder.
- Active or recurrent cancer or currently receiving chemotherapy or radiation therapy.
- Involvement in litigation/worker's compensation claim/receiving disability benefits related to weight-related and/or body shape issues.
- Participation in any type of research in the past 30 days.
About this study
Official title: An Evaluation of the Effectiveness of the Erchonia ML Scanner (MLS) as a Non-invasive Dermatological Aesthetic Treatment for the Reduction of Circumference of the Upper Arms Clinical Study
The purpose of this study is to determine if the Erchonia® ML Scanner (MLS) low level light laser device can help to reduce the circumference of the upper arms.
Read the detailed description
Upper arm body contouring is designed to remove excess skin and/or fatty tissue from the upper arms. Cosmetic procedures are growing in prevalence, upper arm body contouring procedures increased 4059% from 2000 to 2008, and in 2009, just over 16,100 upper arm lifts were performed in the United States (U.S.). Currently available procedures to reduce upper arm circumference include brachioplasty (arm lift), a surgical procedure to remove excess skin and fatty tissue from the upper arm; liposuction of localized fatty deposits in the upper arm; and diet and exercise to reduce excess body fat. Both brachioplasty and liposuction are surgical procedures with risks and potential complications including trauma; fluid accumulation requiring drainage; injury to the skin; infection; permanent scars; and complications from anesthesia. Low level laser light therapy offers a safe, non-invasive and essentially risk-free alternative to reducing upper arm circumference.
The device being evaluated for the reduction of upper arm circumference, the Erchonia ML Scanner (MLS) is cleared by the Food and Drug Administration (FDA) under K082609 for "... use as a non-invasive dermatological aesthetic treatment for the reduction of circumference of hips, waist, and thighs." Furthermore, FDA identifies this generic type of device as: "A Low Level Laser System for Aesthetic Use is a device using low level laser energy for the disruption of adipocyte cells within the fat layer for the release of fat and lipids from these cells for non-invasive aesthetic use." Therefore, the biochemical effect of the Erchonia® MLS low level laser light therapy device stimulates the mitochondria of the adipocyte cells which in turn increases the production of Adenosine-5'-triphosphate (ATP). The newly synthesized ATP triggers the up-regulation of cyclic adenosine monophosphate (cAMP). cAMP has been shown to stimulate cytoplasmic lipase, triggering the conversion of triglycerides into fatty acids and glycerol that can easily pass through the cell membrane. The transitory pore is evidence that the laser is allowing for the movement of fatty acids, glycerol, and triglycerides to pass across the membrane and into extra-cellular space. Through vasodilation of nearby blood vessels and arteries, oxidization of the triglycerides and fatty acids occurs within the extra-cellular space.
- Conditions
- Body Contouring
- Being tested
- Erchonia(r) ML Scanner (MLS), inactive placebo laser device
- Keywords
- upper arm, body contouring, body shaping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erchonia(r) ML Scanner (MLS)Device
The Erchonia ML Scanner (MLS) low level laser light therapy device is administered to both arms for 20 minutes each, 6 times across 2 weeks.
inactive placebo laser deviceDevice
non-therapeutic light application
| Study group | Role | What they receive |
|---|---|---|
| inactive placebo laser device | Placebo comparator | The inactive placebo laser device looks identical to the active laser device, but does not emit any therapeutic light output. Receives: Device: inactive placebo laser device |
| Erchonia ML Scanner (MLS) | Active comparator | The Erchonia ML Scanner (MLS) is a low level laser light therapy device comprising 4 independent rotating diodes, each emitting 17mW 635nm of red laser light. The diodes are mounted in scanner devices positioned 120 degrees apart from each other, tilted at a 30 degree angle. The Erchonia® MLS is activated for 20 minutes per arm during which time the 4 rotating diodes create a spiraling circle pattern that is totally random and independent from the others. These patterns overlap each other to guarantee total coverage within the target area. The total laser energy the test subject is exposed to per treated arm is approximately 3.94 joules per square centimeter. Six procedures are administered evenly across 2 weeks. Receives: Device: Erchonia(r) ML Scanner (MLS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Combined Upper Arm Circumference Measurements From Baseline to Endpoint
Change in combined upper arm circumference measurements is calculated as the difference in combined upper arm circumference measurements from baseline to endpoint (2 weeks) for each of the right upper arm and the left upper arm, separately. A change of at least +1.25 centimeters, for each of the right upper arm and the left upper arm, separately, is considered positive for study success for an individual subject. It was pre-determined that the overall study would be considered a success if at least 50% (16 or more out of 31) of the test group subjects attained individual subject success and individual subject successes in the placebo group were at least 35% lower than for test group subjects (5 or less out of 31).
Measured: baseline and 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2011 (estimated)
- Study startMar 2011
- Primary completionJan 2012
- Study completionJan 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 Body ContouringStudies 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
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erchonia Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mark S Nestor, M.D.,Ph.D., Principal investigatorShari Sanchez, M.D., Principal investigator, unaffilliated
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01376037
- Sponsor's protocol ID
- EC_ARMBC
- Status last verified
- May 2014
- First submitted
- 16 Jun 2011
- Last updated
- 30 May 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation of the Effectiveness of the Erchonia ML Scanner (MLS) as a Non-invasive Dermatological Aesthetic Treatment for the Reduction of Circumference of the Upper Arms Clinical Study
- ClinicalTrials.gov ID
- NCT01376037
- Acronym / sponsor ID
- EC_ARMBC
- Conditions
- Body Contouring
- Keywords
- upper arm, body contouring, body shaping
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Erchonia CorporationIndustry (pharma, biotech, devices)
- Study start
- Mar 2011
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 20 Jun 2011 (estimated)
- Results
- Posted 29 May 2013
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 if the Erchonia® ML Scanner (MLS) low level light laser device can help to reduce the circumference of the upper arms.
Detailed description
Upper arm body contouring is designed to remove excess skin and/or fatty tissue from the upper arms. Cosmetic procedures are growing in prevalence, upper arm body contouring procedures increased 4059% from 2000 to 2008, and in 2009, just over 16,100 upper arm lifts were performed in the United States (U.S.). Currently available procedures to reduce upper arm circumference include brachioplasty (arm lift), a surgical procedure to remove excess skin and fatty tissue from the upper arm; liposuction of localized fatty deposits in the upper arm; and diet and exercise to reduce excess body fat. Both brachioplasty and liposuction are surgical procedures with risks and potential complications including trauma; fluid accumulation requiring drainage; injury to the skin; infection; permanent scars; and complications from anesthesia. Low level laser light therapy offers a safe, non-invasive and essentially risk-free alternative to reducing upper arm circumference.
The device being evaluated for the reduction of upper arm circumference, the Erchonia ML Scanner (MLS) is cleared by the Food and Drug Administration (FDA) under K082609 for "... use as a non-invasive dermatological aesthetic treatment for the reduction of circumference of hips, waist, and thighs." Furthermore, FDA identifies this generic type of device as: "A Low Level Laser System for Aesthetic Use is a device using low level laser energy for the disruption of adipocyte cells within the fat layer for the release of fat and lipids from these cells for non-invasive aesthetic use." Therefore, the biochemical effect of the Erchonia® MLS low level laser light therapy device stimulates the mitochondria of the adipocyte cells which in turn increases the production of Adenosine-5'-triphosphate (ATP). The newly synthesized ATP triggers the up-regulation of cyclic adenosine monophosphate (cAMP). cAMP has been shown to stimulate cytoplasmic lipase, triggering the conversion of triglycerides into fatty acids and glycerol that can easily pass through the cell membrane. The transitory pore is evidence that the laser is allowing for the movement of fatty acids, glycerol, and triglycerides to pass across the membrane and into extra-cellular space. Through vasodilation of nearby blood vessels and arteries, oxidization of the triglycerides and fatty acids occurs within the extra-cellular space.
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 |
|---|---|---|
| inactive placebo laser device | Placebo comparator | Device: inactive placebo laser deviceThe inactive placebo laser device looks identical to the active laser device, but does not emit any therapeutic light output. |
| Erchonia ML Scanner (MLS) | Active comparator | Device: Erchonia(r) ML Scanner (MLS)The Erchonia ML Scanner (MLS) is a low level laser light therapy device comprising 4 independent rotating diodes, each emitting 17mW 635nm of red laser light. The diodes are mounted in scanner devices positioned 120 degrees apart from each other, tilted at a 30 degree angle. The Erchonia® MLS is activated for 20 minutes per arm during which time the 4 rotating diodes create a spiraling circle pattern that is totally random and independent from the others. These patterns overlap each other to guarantee total coverage within the target area. The total laser energy the test subject is exposed to per treated arm is approximately 3.94 joules per square centimeter. Six procedures are administered evenly across 2 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subject indicated for liposuction, or use of liposuction techniques, for the removal of localized deposits of adipose tissues that do not respond to diet and exercise; specifically for the indication of body contouring of the bilateral upper arms (As per the American Academy of Cosmetic Surgery's 2006 Guidelines for Liposuction Surgery developed by A joint Ad Hoc Committee of the American Society of Liposuction Surgery (ASLSS) and the American Academy of Cosmetic Surgery (AACS)), and/or for the procedure of brachioplasty (upper arm lift).
- Body Mass Index (BMI) of 20 to 35 kg/m².
- Subject is willing and able to abstain from partaking in any treatment other than the study procedure to promote body contouring and/or weight loss during study participation.
- Subject is willing and able to maintain his or her regular (typical pre-study procedure) diet and exercise regimen without effecting significant change in either direction during study participation.
Key exclusion criteria (18 listed)
- Subject is seeking upper arm body contouring as a means of weight loss.
- Diabetes dependent on insulin or oral hypoglycemic medications.
- 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 of the arms, such as liposuction or brachioplasty.
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(r) ML Scanner (MLS)The Erchonia ML Scanner (MLS) low level laser light therapy device is administered to both arms for 20 minutes each, 6 times across 2 weeks. | Device | Erchonia ML Scanner (MLS) |
| inactive placebo laser devicenon-therapeutic light application | Device | inactive placebo laser device |
Primary outcome
Change in Combined Upper Arm Circumference Measurements From Baseline to Endpoint
Time frame: baseline and 2 weeks
Change in combined upper arm circumference measurements is calculated as the difference in combined upper arm circumference measurements from baseline to endpoint (2 weeks) for each of the right upper arm and the left upper arm, separately. A change of at least +1.25 centimeters, for each of the right upper arm and the left upper arm, separately, is considered positive for study success for an individual subject. It was pre-determined that the overall study would be considered a success if at least 50% (16 or more out of 31) of the test group subjects attained individual subject success and individual subject successes in the placebo group were at least 35% lower than for test group subjects (5 or less out of 31).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2014.
- 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.
Mark S Nestor, M.D.,Ph.D. principal investigator
Shari Sanchez, M.D. principal investigator
unaffilliated
Questions about this trial
What is this clinical trial studying?
A study testing Erchonia(r) ML Scanner (MLS) in people with Body Contouring, run by Erchonia Corporation.
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 4 inclusion and 18 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 30 May 2014. Status can change between updates, so confirm with the study contact before making plans.
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 29 May 2013). 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?
Change in Combined Upper Arm Circumference Measurements From Baseline to Endpoint (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 30 May 2014; AzTrials last refreshed its copy on 6 Nov 2026.