ObesityNCT03470272
Effects of Red Light LED Therapy on Body Contouring
A study testing FB Professional LED Red light therapy and Effects of Red Light LED Therapy on Body Contouring in people with Obesity, run by Manamed Inc. at 1 site in United States.
Trial summary
Red light laser therapy using 635nm red light laser technology has previously been shown to cause lipolysis in subcutaneous fat as a non-surgical method to promote weight loss and body contouring. Read more about this study
- Who is it for?
- Ages 18 to 77 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- FB Professional LED Red light therapy and Effects of Red Light LED Therapy on Body Contouring
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Sep 2018to 30 Nov 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 to 77 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- At least 18 years or older.
- May be male or female.
- Generally good health.
Who cannot join
- Minors.
- Open wounds or sores.
- Pacemaker.
- Photosensitivity.
- Epilepsy.
- Any form of cancer.
Show all 9Show fewer
- Severe kidney or liver problems.
- Thyroid problems.
- Pregnant or nursing.
Trial locations and contacts
1 site in 1 country.
United States1 site
Ligertwood Chiropractic
New Port Richey, Florida, 34654
About this study
Red light laser therapy using 635nm red light laser technology has previously been shown to cause lipolysis in subcutaneous fat as a non-surgical method to promote weight loss and body contouring. This study hypothesizes that red LED light therapy using 650nm red light LED (light emitting diode) technology produces similar results to the laser device (red LASER 635nm) when preformed using a specified treatment protocol.
Read the detailed description
Red light laser therapy using 635nm red light laser technology has previously been shown to cause lipolysis in subcutaneous fat as a non-surgical method to promote weight loss and body contouring. This study hypothesizes that red LED light therapy using 650nm red light LED (light emitting diode) technology produces similar results to the laser device (red LASER 635nm) when preformed using a specified treatment protocol.
Furthermore, it is hypothesized that the Vevazz therapy program achieves the results after one 28 minute treatment period. The predicate 635nm LED device (Photonica Professional by Ward Photonics) achieves its results after one 32 minute therapy program.
The FB Professional therapy program uses the FB Professional LED device for fat removal using LED red light therapy. This multi-site study reviews results from 70 randomly selected patients after a single treatment using the FB Professional LED device.
- Conditions
- Obesity
- Being tested
- FB Professional LED Red light therapy, Effects of Red Light LED Therapy on Body Contouring
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FB Professional LED Red light therapyDevice
Also called Effects of Red Light LED Therapy on Body Contouring
FB Professional LED red light therapy is a non-invasive dermatological aesthetic treatment for the reduction of circumference of hips, waist and thighs. Measure before and after effects of device unit. Three measurements before of circumference of abdomen area and three measurements after comparing the results.
Effects of Red Light LED Therapy on Body ContouringDevice
Intervention is to take a sample and measure before and after using a sham unit (placebo) and take three measurements of abdominal before treatment and three measurements after sham treatment and compare to controlled treatment.
| Study group | Role | What they receive |
|---|---|---|
| Active Device | Experimental | Active Device: The FB Professional LED red light therapy system
FB Professional is a treatment regime using the FB Professional device for fat removal using red light therapy.
Intervention device: FB Professional LED red light therapy is a non-invasive dermatological aesthetic treatment for the reduction of circumference of hips, waist and thighs. Receives: Device: FB Professional LED Red light therapy; Device: Effects of Red Light LED Therapy on Body Contouring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Fat Amount (Reduction) in Treatment Area as Measured in Inches Lost
Circumferential measurement of thighs, hips and waist before and after treatment.
Measured: One 28 minute session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2018
- Study start30 Sep 2018 (estimated)
- Primary completion30 Nov 2018 (estimated)
- Study completion30 Nov 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Manamed Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Paul Ligertwood, Dr, Principal investigator, Human Studies Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03470272
- Sponsor's protocol ID
- Manamed
- Status last verified
- Aug 2018
- First submitted
- 14 Dec 2017
- Last updated
- 17 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Red Light LED Therapy on Body Contouring
- ClinicalTrials.gov ID
- NCT03470272
- Acronym / sponsor ID
- Manamed
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Manamed Inc.Industry (pharma, biotech, devices)
- Study start
- 30 Sep 2018 (estimated)
- Primary completion
- 30 Nov 2018 (estimated)
- Study completion
- 30 Nov 2018 (estimated)
- First posted
- 19 Mar 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.
Red light laser therapy using 635nm red light laser technology has previously been shown to cause lipolysis in subcutaneous fat as a non-surgical method to promote weight loss and body contouring. This study hypothesizes that red LED light therapy using 650nm red light LED (light emitting diode) technology produces similar results to the laser device (red LASER 635nm) when preformed using a specified treatment protocol.
Detailed description
Red light laser therapy using 635nm red light laser technology has previously been shown to cause lipolysis in subcutaneous fat as a non-surgical method to promote weight loss and body contouring. This study hypothesizes that red LED light therapy using 650nm red light LED (light emitting diode) technology produces similar results to the laser device (red LASER 635nm) when preformed using a specified treatment protocol.
Furthermore, it is hypothesized that the Vevazz therapy program achieves the results after one 28 minute treatment period. The predicate 635nm LED device (Photonica Professional by Ward Photonics) achieves its results after one 32 minute therapy program.
The FB Professional therapy program uses the FB Professional LED device for fat removal using LED red light therapy. This multi-site study reviews results from 70 randomly selected patients after a single treatment using the FB Professional LED device.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Active Device | Experimental | Device: FB Professional LED Red light therapy, Device: Effects of Red Light LED Therapy on Body ContouringActive Device: The FB Professional LED red light therapy system FB Professional is a treatment regime using the FB Professional device for fat removal using red light therapy. Intervention device: FB Professional LED red light therapy is a non-invasive dermatological aesthetic treatment for the reduction of circumference of hips, waist and thighs. |
Who may qualify
- Ages
- 18 to 77 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- At least 18 years or older.
- May be male or female.
- Generally good health.
Key exclusion criteria (9 listed)
- Minors.
- Open wounds or sores.
- Pacemaker.
- Photosensitivity.
- Epilepsy.
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 |
|---|---|---|
| FB Professional LED Red light therapyAlso: Effects of Red Light LED Therapy on Body ContouringFB Professional LED red light therapy is a non-invasive dermatological aesthetic treatment for the reduction of circumference of hips, waist and thighs. Measure before and after effects of device unit. Three measurements before of circumference of abdomen area and three measurements after comparing the results. | Device | Active Device |
| Effects of Red Light LED Therapy on Body ContouringIntervention is to take a sample and measure before and after using a sham unit (placebo) and take three measurements of abdominal before treatment and three measurements after sham treatment and compare to controlled treatment. | Device | Active Device |
Primary outcome
Change in Fat Amount (Reduction) in Treatment Area as Measured in Inches Lost
Time frame: One 28 minute session
Circumferential measurement of thighs, hips and waist before and after treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2018.
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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.
Paul Ligertwood, Dr principal investigator
Human Studies Group
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FB Professional LED Red light therapy and Effects of Red Light LED Therapy on Body Contouring in people with Obesity, run by Manamed Inc. at 1 site 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 3 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 17 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 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mark Julian (7276419399, glacierheat1@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Fat Amount (Reduction) in Treatment Area as Measured in Inches Lost (time frame: One 28 minute session). 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 17 Aug 2018.