A Retrospective Analysis of the Effects of Red Light Therapy on Body Contouring
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|ClinicalTrials.gov Identifier: NCT02867150|
Recruitment Status : Completed
First Posted : August 15, 2016
Results First Posted : June 23, 2017
Last Update Posted : June 23, 2017
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|Condition or disease||Intervention/treatment||Phase|
|Obesity||Device: Ward Photonics Photonica Professional||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||58 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Retrospective Analysis of the Effects of Red Light Therapy on Body Contouring|
|Study Start Date :||October 2015|
|Actual Primary Completion Date :||October 2015|
|Actual Study Completion Date :||October 2015|
Experimental: Active Device
Active Device: Ward Photonics Photonica Professional Red light therapy system Intervention: Device: Ward Photonics Photonica Professional
Device: Ward Photonics Photonica Professional
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.
- 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.
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|Ages Eligible for Study:||18 Years to 74 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
- 18 years or older.
- Male or female.
- Generally good health.
- Active cancer within the past year.
- Diminished ability to void waste (liver or kidneys).
- Photosensitive condition or medication.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02867150
|Principal Investigator:||Terry J Ward, M.H.A.||Managing Director|
|Responsible Party:||Ward Photonics LLC|
|Other Study ID Numbers:||
|First Posted:||August 15, 2016 Key Record Dates|
|Results First Posted:||June 23, 2017|
|Last Update Posted:||June 23, 2017|
|Last Verified:||June 2017|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Plan Description:||No current plan to share data.|