Fat ReductionCellulizeNCT03647748
Effects of Green Light Therapy on Body Contouring and Cellulite
A study of Fat Reduction, run by Ward Photonics LLC at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fat Reduction
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 4 sitesUnited States
- Study dates
- Jan 2017to Aug 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 13Show fewer
- 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.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Michigan Center for Cosmetic Surgery, Ann Arbor, Michigan
Ann Arbor, Michigan, 48104
Wunderlich Chiropractic Clinic
Cape Coral, Florida, 33904
Mobile Laser Slimming
Cocoa Beach, Florida, 32931
Lake Mary Health and Wellness
Lake Mary, Florida, 32714
About this study
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.
Read the 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
- Being tested
- Sham Comparator
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sham ComparatorDevice
A modified device utilizing a pigtail connector to bypass active treatment.
| Study group | Role | What they receive |
|---|---|---|
| Cellulize 532nm | No intervention | Cellulize device using 532nm Green Light. |
| Cellulize Placebo (Sham Comparator) | Sham comparator | Cellulize modified to appear as if it is running, but does not use the 532nm light.
"Sham" Device, or "Placebo." Receives: Device: Sham Comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average Change in Inches of Total Circumference Measurements
Average Change in Inches of Total Circumference Measurements for effect of Cellulize, a LED 532nm green light low level laser system for aesthetic use for the non-invasive reduction in fat layer for body contouring from baseline measurements, and after treatment.
Measured: 2 weeks
Secondary outcomes (2)
Durability of Effect
Durability of Effect: a term used to indicate whether the results of the primary outcome endure at the 2 week follow up time point. If the average change in inches of total circumference continues decreasing or stays the same, then the durability of effect is assumed to endure for at least two weeks. If the measurements at the 2-week time point show that the changes in inches return to previous measures at the start of treatment, then the effect is considered temporary.
Measured: 2 weeks
Change in appearance of cellulite
Change in appearance of cellulite is a measure of the Nurnberger-Muller Scale (NMS) from baseline to 2 weeks post-assessment for both of the right and left thighs.
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 posted27 Aug 2018
- Study startJan 2017
- Primary completionAug 2018
- Study completionAug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fat 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients randomly assigned to either the active 532nm treatment group, or the sham device (placebo) group using a modified device rigged to not treat patients.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ward Photonics LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert H Burke, MD, Study director, Michigan Center for Cosmetic Surgery, Ann Arbor, Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03647748
- Sponsor's protocol ID
- CP16-02
- Acronym
- Cellulize
- Status last verified
- Aug 2018
- First submitted
- 20 Aug 2018
- Last updated
- 27 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Green Light Therapy on Body Contouring and Cellulite
- ClinicalTrials.gov ID
- NCT03647748
- Acronym / sponsor ID
- Cellulize / CP16-02
- Conditions
- Fat Reduction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Ward Photonics LLCIndustry (pharma, biotech, devices)
- Study start
- Jan 2017 (actual)
- Primary completion
- Aug 2018 (actual)
- Study completion
- Aug 2018 (actual)
- First posted
- 27 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Patients randomly assigned to either the active 532nm treatment group, or the sham device (placebo) group using a modified device rigged to not treat patients.
| Arm | Type | Receives |
|---|---|---|
| Cellulize 532nm | No intervention | –Cellulize device using 532nm Green Light. |
| Cellulize Placebo (Sham Comparator) | Sham comparator | Device: Sham ComparatorCellulize modified to appear as if it is running, but does not use the 532nm light. "Sham" Device, or "Placebo." |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
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 |
|---|---|---|
| Sham ComparatorA modified device utilizing a pigtail connector to bypass active treatment. | Device | Cellulize Placebo (Sham Comparator) |
Primary outcome
Average Change in Inches of Total Circumference Measurements
Time frame: 2 weeks
Average Change in Inches of Total Circumference Measurements for effect of Cellulize, a LED 532nm green light low level laser system for aesthetic use for the non-invasive reduction in fat layer for body contouring from baseline measurements, and after treatment.
2 secondary outcomes
Durability of Effect
Time frame: 2 weeks
Change in appearance of cellulite
Time frame: 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2018.
- Individual participant dataSharing planned: No
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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.
Robert H Burke, MD study director
Michigan Center for Cosmetic Surgery, Ann Arbor, Michigan
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Fat Reduction, run by Ward Photonics LLC at 4 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 13 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 27 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Average Change in Inches of Total Circumference Measurements (time frame: 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 27 Aug 2018.