ObesityNCT02867150
A Retrospective Analysis of the Effects of Red Light Therapy on Body Contouring
A study testing Ward Photonics Photonica Professional in people with Obesity, run by Ward Photonics LLC.
Trial summary
The purpose of this study is to determine whether red light therapy using LED 635nm red light for body contouring of the waist, hips and thighs is as effective as red light therapy using Laser 635nm red light. Read more about this study
- Who is it for?
- Ages 18 to 74 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Ward Photonics Photonica Professional
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- No sites listed yet
- Study dates
- Oct 2015to Oct 2015
- 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 74 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years or older.
- Male or female.
- Generally good health.
Who cannot join
- Pregnancy.
- Active cancer within the past year.
- Diminished ability to void waste (liver or kidneys).
- Photosensitive condition or medication.
About this study
The purpose of this study is to determine whether red light therapy using LED 635nm red light for body contouring of the waist, hips and thighs is as effective as red light therapy using Laser 635nm red light.
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 635nm red light LED (light emitting diode) technology produces similar results to the laser device (red LASER 635nm) when performed using a specified treatment protocol.
Furthermore, it is hypothesized that the UltraSlim Cold Light therapy program achieves the results after a single 32-minute treatment. The predicate 635nm laser device (Zerona by Erchonia) achieves its results after six treatments combined with a diet and exercise regimen.
UltraSlim Cold Light® is a patented process using the Photonica Professional device for fat removal using LED red light therapy. This multi-site study reviews results from 58 randomly selected patients after a single treatment using the Photonica Professional device (i.e. UltraSlim Cold Light®).
- Conditions
- Obesity
- Being tested
- Ward Photonics Photonica Professional
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ward Photonics Photonica ProfessionalDevice
Active Device: Ward Photonics, Photonica Professional Red light therapy system
UltraSlim Cold Light® is the name of a patented treatment regimen using the Photonica Professional device for fat removal using LED red light therapy.
| Study group | Role | What they receive |
|---|---|---|
| Active Device | Experimental | Active Device: Ward Photonics Photonica Professional Red light therapy system Intervention: Device: Ward Photonics Photonica Professional Receives: Device: Ward Photonics Photonica Professional |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fat Reduction in Treatment Zone as Measured in Inches Lost
Circumferential measurement of thighs, hips and waist before and after treatment.
Measured: Single 32-minute treatment session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2016 (estimated)
- Study startOct 2015
- Primary completionOct 2015
- Study completionOct 2015
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 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
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ward Photonics LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Terry J Ward, M.H.A., Principal investigator, Managing Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02867150
- Sponsor's protocol ID
- MLS-1510
- Status last verified
- Jun 2017
- First submitted
- 3 Jan 2016
- Last updated
- 23 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No: No current plan to share data.
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Analysis of the Effects of Red Light Therapy on Body Contouring
- ClinicalTrials.gov ID
- NCT02867150
- Acronym / sponsor ID
- MLS-1510
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Ward Photonics LLCIndustry (pharma, biotech, devices)
- Study start
- Oct 2015
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 15 Aug 2016 (estimated)
- Results
- Posted 23 Jun 2017
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 red light therapy using LED 635nm red light for body contouring of the waist, hips and thighs is as effective as red light therapy using Laser 635nm red light.
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 635nm red light LED (light emitting diode) technology produces similar results to the laser device (red LASER 635nm) when performed using a specified treatment protocol.
Furthermore, it is hypothesized that the UltraSlim Cold Light therapy program achieves the results after a single 32-minute treatment. The predicate 635nm laser device (Zerona by Erchonia) achieves its results after six treatments combined with a diet and exercise regimen.
UltraSlim Cold Light® is a patented process using the Photonica Professional device for fat removal using LED red light therapy. This multi-site study reviews results from 58 randomly selected patients after a single treatment using the Photonica Professional device (i.e. UltraSlim Cold Light®).
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: Ward Photonics Photonica ProfessionalActive Device: Ward Photonics Photonica Professional Red light therapy system Intervention: Device: Ward Photonics Photonica Professional |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years or older.
- Male or female.
- Generally good health.
Key exclusion criteria (4 listed)
- Pregnancy.
- Active cancer within the past year.
- Diminished ability to void waste (liver or kidneys).
- Photosensitive condition or medication.
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 |
|---|---|---|
| Ward Photonics Photonica ProfessionalActive Device: Ward Photonics, Photonica Professional Red light therapy system UltraSlim Cold Light® is the name of a patented treatment regimen using the Photonica Professional device for fat removal using LED red light therapy. | Device | Active Device |
Primary outcome
Fat Reduction in Treatment Zone as Measured in Inches Lost
Time frame: Single 32-minute treatment session
Circumferential measurement of thighs, hips and waist before and after treatment.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. No current plan to share data.
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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.
Terry J Ward, M.H.A. principal investigator
Managing Director
Questions about this trial
What is this clinical trial studying?
A study testing Ward Photonics Photonica Professional in people with Obesity, run by Ward Photonics LLC.
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 4 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 23 Jun 2017. 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. 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 23 Jun 2017). 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?
Fat Reduction in Treatment Zone as Measured in Inches Lost (time frame: Single 32-minute treatment 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 23 Jun 2017.