Circumference ReductionNCT02109107
Study of Low Level Laser Light Therapy on Circumference Reduction
A study testing Erchonia EZ6 Laser in people with Circumference Reduction, run by Erchonia Corporation at 2 sites in United States.
Trial summary
The purpose of this study is to determine whether low level laser light therapy is effective in reducing circumference of the waist, hips, thighs and upper abdomen over a 6 week period. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Circumference Reduction
- What is being tested?
- Erchonia EZ6 Laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2013to Nov 2014
- 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
- Body Mass Index (BMI) between 25 kg/m² and 40 kg/m²
- 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 for the hips, waist, thighs and upper abdomen. (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 Lipo-Suction Surgery (ASLSS) and the American Academy of Cosmetic Surgery (AACS))
- Willing and able to abstain from treatments other than the study procedure for body contouring/circumference reduction/weight loss during study participation
- Willing and able to maintain typical diet and exercise regimen during study participation
Who cannot join
- Body Mass Index (BMI) less than 25 kg/m² or greater than 40 kg/m²
- Known cardiovascular disease
- Cardiac surgeries such as bypass, heart transplant surgery, pacemakers
- Prior surgical intervention for body sculpting/weight loss
- Medical, physical, or other contraindications for body sculpting/weight loss
- Current use of medication known to affect weight levels/cause bloating or swelling and for which abstinence during study participation is not possible
Show all 16Show fewer
- Any medical condition known to affect weight levels and/or 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
- Known photosensitivity disorder
- Active cancer or currently receiving treatment for cancer
- Pregnant or planning pregnancy prior to study participation end
- Serious mental health illness such as dementia/schizophrenia; psychiatric hospitalization in past two years.
- Developmental disability or cognitive impairment that may preclude adequate comprehension of the consent form and/or ability to record the study measures
- Involvement in litigation/worker's compensation/disability benefits related to the study parameters
- Participation in clinical research in the past 30 days
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Advanced Gynecology Specialists of Augusta, LLC
Evans, Georgia, 30809
CT Dermatology PC
Fruitland, Idaho, 83619
About this study
Official title: An Evaluation of the Effect of the Erchonia® Zerona 6 Headed Scanner (EZ6) Six-week Treatment Protocol on Circumference Reduction of the Waist, Hips, Thighs and Upper Abdomen Clinical Study Protocol
The purpose of this study is to determine whether low level laser light therapy is effective in reducing circumference of the waist, hips, thighs and upper abdomen over a 6 week period.
Read the detailed description
The American Society of Plastic Surgeons (ASPS) 2011 report states that the market for cosmetic procedures has shown significant growth over the past two years, with 13.8 million cosmetic plastic surgery procedures performed in the United States in 2011, up 5% since 2010. While surgical cosmetic procedures significantly increased from 2010 to 2011, the overall growth in cosmetic procedures is primarily driven by a substantial rise in minimally-invasive procedures, that increased 6%, with nearly 12.2 million cosmetic minimally-invasive procedures having been performed in 2011. This highlights the growing consumer demand for non- or minimally-invasive cosmetic procedures that do not involve surgical procedures such as liposuction and the associated risks, potential complications and lengthy and painful recovery processes.
Low level laser light therapy offers a simple, non-invasive, safe, effective and side-effect free alternative to achieving body circumference reduction.
Justification for the assertion of anticipated safety and effectiveness of application of the Erchonia® EZ6 Laser low level laser therapy for the reduction of body circumference is found through three Food and Drug Administration (FDA) clearances for Erchonia® Low Level Laser devices for body circumference reduction indications, as follows:
K123237 (532 nanometer (nm) green light diodes): Erchonia® Zerona™ 2.0 Laser: is indicated for use as a non-invasive dermatological aesthetic treatment as an adjunct for individuals intending to undergo liposuction procedures for the reduction of circumference of hips, waist, and thighs.
K121695 \& K082609 (635 nm red light diodes): Erchonia® ML Scanner (MLS) \& Erchonia® Zerona: is indicated for use as a non-invasive dermatological aesthetic treatment as an adjunct for individuals intending to undergo liposuction procedures for the reduction of circumference of hips, waist, and thighs.
K121690 \& K120257 (635 nm red light diodes): Erchonia® MLS, Zerona: is indicated for use as a non-invasive dermatological aesthetic treatment as an adjunct for individuals intending to undergo liposuction procedures for the reduction of circumference of the upper arms.
Therefore, Erchonia low level lasers have been determined safe and effective by the FDA for application for body circumference reduction indications for multiple body areas. The intended application/indication of the EZ6 in this study is comparable to the above FDA-cleared indications, with the study intent being to evaluate the comparative efficacy of a six week, once weekly 60 minute treatment administration protocol employing 6 red light diodes to the established efficacy of the current two week, thrice weekly 40 minute treatment administration protocol with application of five red light diodes on reduction of hips, waist, thighs and upper abdomen circumference.
- Conditions
- Circumference Reduction
- Being tested
- Erchonia EZ6 Laser
- Keywords
- body contouring, body shaping, circumference reduction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erchonia EZ6 LaserDevice
Also called Erchonia® Zerona 6 Headed Scanner
The Erchonia EZ6 is administered 6 times across 6 consecutive weeks, each administration seven days apart, each treatment lasting 60 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Erchonia EZ6 Laser | Experimental | The Erchonia EZ6 Laser is a 6 headed scanner composed of 6 independent 17 milliWatts (mW), 635 nanometer (nm) red laser diodes mounted in scanner devices. It is a variable frequency, pulsed wave laser device. Receives: Device: Erchonia EZ6 Laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Combined Circumference Measurements
Combined circumference measurement is calculated as the sum of the measurements for the individual body areas of the right and left thighs, hips, waist and upper abdomen. Change in combined circumference measurements is calculated as the difference in measurements from baseline to after completion of the 6-week procedure administration period. A negative (-) change indicates a reduction in combined circumference measurement across the evaluation period and is positive for study success. A positive (+) change indicates an increase in combined circumference measurements across the evaluation period and is negative for study success.
A mean change for the study subject group of -3.0 inches or more in combined circumference measurements will be considered a clinically meaningful and statistically significant positive change indicative of study success.
Measured: Baseline and 6 weeks
Secondary outcomes (3)
Change in Body Weight
Body weight was measured in pounds at each evaluation point. The change in body weight measured in pounds at 6 weeks post-procedure administration relative to baseline was calculated. An increase in body weight indicated that weight was gained across the study evaluation period while a decrease in body weight indicated that weight was lost across the study evaluation period.
Measured: Baseline and 6 weeks
Change in Body Mass Index (BMI)
Body mass index (BMI) was measured in kilograms per meter squared (kg/m2) at each evaluation point. The change in BMI measured at 6 weeks post-procedure administration relative to baseline was calculated. An increase in BMI indicated that BMI increased across the study evaluation period which is negative for study success, while a decrease in BMI indicated that BMI decreased across the study evaluation period which is positive for study success.
Measured: Baseline and 6 weeks
Subject Satisfaction With Study Outcome Rating
At the end of the study procedure administration phase, the subject was asked to indicate how satisfied or dissatisfied they were with any change noticed in the appearance of the thighs, hips, waist and upper abdomen area after having received the procedures with the EZ6?", using the following five-point scale: Very Satisfied; Somewhat Satisfied; Neither Satisfied nor Dissatisfied; Not Very Satisfied; Not at All Satisfied
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2014 (estimated)
- Study startOct 2013
- Primary completionNov 2014
- Study completionNov 2014
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Circumference ReductionStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erchonia Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Carl R Thornfeldt, MD, Principal investigatorPaul M Thaxton, MD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02109107
- Sponsor's protocol ID
- EC_EZ6_BC_001
- Status last verified
- Dec 2015
- First submitted
- 7 Apr 2014
- Last updated
- 2 Feb 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Thornfeldt CR, Thaxton PM, Hornfeldt CS. A Six-week Low-level Laser Therapy Protocol is Effective for Reducing Waist, Hip, Thigh, and Upper Abdomen Circumference. J Clin Aesthet Dermatol. 2016 Jun;9(6):31-5. Epub 2016 Jun 1.
PubMed 27386049
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation of the Effect of the Erchonia® Zerona 6 Headed Scanner (EZ6) Six-week Treatment Protocol on Circumference Reduction of the Waist, Hips, Thighs and Upper Abdomen Clinical Study Protocol
- ClinicalTrials.gov ID
- NCT02109107
- Acronym / sponsor ID
- EC_EZ6_BC_001
- Conditions
- Circumference Reduction
- Keywords
- body contouring, body shaping, circumference reduction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Erchonia CorporationIndustry (pharma, biotech, devices)
- Study start
- Oct 2013
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 9 Apr 2014 (estimated)
- Results
- Posted 2 Feb 2016
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 low level laser light therapy is effective in reducing circumference of the waist, hips, thighs and upper abdomen over a 6 week period.
Detailed description
The American Society of Plastic Surgeons (ASPS) 2011 report states that the market for cosmetic procedures has shown significant growth over the past two years, with 13.8 million cosmetic plastic surgery procedures performed in the United States in 2011, up 5% since 2010. While surgical cosmetic procedures significantly increased from 2010 to 2011, the overall growth in cosmetic procedures is primarily driven by a substantial rise in minimally-invasive procedures, that increased 6%, with nearly 12.2 million cosmetic minimally-invasive procedures having been performed in 2011. This highlights the growing consumer demand for non- or minimally-invasive cosmetic procedures that do not involve surgical procedures such as liposuction and the associated risks, potential complications and lengthy and painful recovery processes.
Low level laser light therapy offers a simple, non-invasive, safe, effective and side-effect free alternative to achieving body circumference reduction.
Justification for the assertion of anticipated safety and effectiveness of application of the Erchonia® EZ6 Laser low level laser therapy for the reduction of body circumference is found through three Food and Drug Administration (FDA) clearances for Erchonia® Low Level Laser devices for body circumference reduction indications, as follows:
K123237 (532 nanometer (nm) green light diodes): Erchonia® Zerona™ 2.0 Laser: is indicated for use as a non-invasive dermatological aesthetic treatment as an adjunct for individuals intending to undergo liposuction procedures for the reduction of circumference of hips, waist, and thighs.
K121695 \& K082609 (635 nm red light diodes): Erchonia® ML Scanner (MLS) \& Erchonia® Zerona: is indicated for use as a non-invasive dermatological aesthetic treatment as an adjunct for individuals intending to undergo liposuction procedures for the reduction of circumference of hips, waist, and thighs.
K121690 \& K120257 (635 nm red light diodes): Erchonia® MLS, Zerona: is indicated for use as a non-invasive dermatological aesthetic treatment as an adjunct for individuals intending to undergo liposuction procedures for the reduction of circumference of the upper arms.
Therefore, Erchonia low level lasers have been determined safe and effective by the FDA for application for body circumference reduction indications for multiple body areas. The intended application/indication of the EZ6 in this study is comparable to the above FDA-cleared indications, with the study intent being to evaluate the comparative efficacy of a six week, once weekly 60 minute treatment administration protocol employing 6 red light diodes to the established efficacy of the current two week, thrice weekly 40 minute treatment administration protocol with application of five red light diodes on reduction of hips, waist, thighs and upper abdomen circumference.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Erchonia EZ6 Laser | Experimental | Device: Erchonia EZ6 LaserThe Erchonia EZ6 Laser is a 6 headed scanner composed of 6 independent 17 milliWatts (mW), 635 nanometer (nm) red laser diodes mounted in scanner devices. It is a variable frequency, pulsed wave laser device. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Body Mass Index (BMI) between 25 kg/m² and 40 kg/m²
- 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 for the hips, waist, thighs and upper abdomen. (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 Lipo-Suction Surgery (ASLSS) and the American Academy of Cosmetic Surgery (AACS))
- Willing and able to abstain from treatments other than the study procedure for body contouring/circumference reduction/weight loss during study participation
- Willing and able to maintain typical diet and exercise regimen during study participation
Key exclusion criteria (16 listed)
- Body Mass Index (BMI) less than 25 kg/m² or greater than 40 kg/m²
- Known cardiovascular disease
- Cardiac surgeries such as bypass, heart transplant surgery, pacemakers
- Prior surgical intervention for body sculpting/weight loss
- Medical, physical, or other contraindications for body sculpting/weight loss
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 EZ6 LaserAlso: Erchonia® Zerona 6 Headed ScannerThe Erchonia EZ6 is administered 6 times across 6 consecutive weeks, each administration seven days apart, each treatment lasting 60 minutes. | Device | Erchonia EZ6 Laser |
Primary outcome
Change in Combined Circumference Measurements
Time frame: Baseline and 6 weeks
Combined circumference measurement is calculated as the sum of the measurements for the individual body areas of the right and left thighs, hips, waist and upper abdomen. Change in combined circumference measurements is calculated as the difference in measurements from baseline to after completion of the 6-week procedure administration period. A negative (-) change indicates a reduction in combined circumference measurement across the evaluation period and is positive for study success. A positive (+) change indicates an increase in combined circumference measurements across the evaluation period and is negative for study success. A mean change for the study subject group of -3.0 inches or more in combined circumference measurements will be considered a clinically meaningful and statistically significant positive change indicative of study success.
3 secondary outcomes
Change in Body Weight
Time frame: Baseline and 6 weeks
Change in Body Mass Index (BMI)
Time frame: Baseline and 6 weeks
Subject Satisfaction With Study Outcome Rating
Time frame: 6 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 27386049Thornfeldt CR, Thaxton PM, Hornfeldt CS. A Six-week Low-level Laser Therapy Protocol is Effective for Reducing Waist, Hip, Thigh, and Upper Abdomen Circumference. J Clin Aesthet Dermatol. 2016 Jun;9(6):31-5. Epub 2016 Jun 1.
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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.
Carl R Thornfeldt, MD principal investigator
Paul M Thaxton, MD 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 EZ6 Laser in people with Circumference Reduction, 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 4 inclusion and 16 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 2 Feb 2016. 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. 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 2 Feb 2016). 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 Circumference Measurements (time frame: Baseline and 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02109107, which also lists 1 linked publication.
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 2 Feb 2016.