Obesity
Conditions
Brief 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.
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®).
Interventions
DEVICEWard 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.
Sponsors
Ward Photonics LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 74 Years
Healthy volunteers
Yes
Inclusion criteria
* 18 years or older. * Male or female. * Generally good health.
Exclusion criteria
* Pregnancy. * Active cancer within the past year. * Diminished ability to void waste (liver or kidneys). * Photosensitive condition or medication.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fat Reduction in Treatment Zone as Measured in Inches Lost | Single 32-minute treatment session | Circumferential measurement of thighs, hips and waist before and after treatment. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Active Device Active Device: Ward Photonics Photonica Professional Red light therapy system Intervention: Device: Ward Photonics Photonica Professional
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. | 58 |
| Total | 58 |
Baseline characteristics
| Characteristic | Active Device |
|---|---|
| Age, Categorical <=18 years | 1 Participants |
| Age, Categorical >=65 years | 3 Participants |
| Age, Categorical Between 18 and 65 years | 54 Participants |
| Age, Continuous | 43.3 Years |
| Region of Enrollment United States | 58 participants |
| Sex: Female, Male Female | 46 Participants |
| Sex: Female, Male Male | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 58 |
| serious Total, serious adverse events | 0 / 58 |
Outcome results
Primary
Fat Reduction in Treatment Zone as Measured in Inches Lost
Circumferential measurement of thighs, hips and waist before and after treatment.
Time frame: Single 32-minute treatment session
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Active Device | Fat Reduction in Treatment Zone as Measured in Inches Lost | 3.5 inch |