Effects of Red Light LED Therapy on Body Contouring
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ClinicalTrials.gov Identifier: NCT03242564 |
Recruitment Status :
Completed
First Posted : August 8, 2017
Last Update Posted : August 8, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Obesity | Device: Vevazz LED | 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 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 a single 28 minute treatment. The predicate 635nm LED device (Photonica Professional by Ward Photonics) achieves its results after one 32 minute therapy program.
The Vevazz therapy program uses the Vevazz LED device for fat removal using LED red light therapy. This multi-site study reviews results from 66 randomly selected patients after a single treatment using the Vevazz LED device.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 66 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Retrospective Analysis of the Effects of Red Light LED Therapy on Body Contouring |
Actual Study Start Date : | July 10, 2017 |
Actual Primary Completion Date : | July 21, 2017 |
Actual Study Completion Date : | July 21, 2017 |
Arm | Intervention/treatment |
---|---|
Experimental: Active Device
Active Device: Vevazz LED red light therapy system Vevazz LED red light therapy system is a treatment regimen using the Vevazz LED device for fat removal using LED red light therapy. |
Device: Vevazz LED
Vevazz LED red light therapy is a non-invasive dermatological aesthetic treatment for the reduction of circumference of hips, waist and thighs. |
- Change in Fat Amount (Reduction) in Treatment Area as Measured in Inches Lost [ Time Frame: One 28 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 77 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- At least 18 years or older.
- May be male or female.
- Generally good health.
Exclusion Criteria:
- Minors.
- Open wounds or sores.
- Pacemaker.
- Photosensitivity.
- Epilepsy.
- Any form of cancer.
- Severe kidney or liver problems.
- Thyroid problems.
- Pregnant or nursing.

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): NCT03242564
United States, Texas | |
Vevazz, LLC | |
Dallas, Texas, United States, 75204 |
Study Director: | Jamie Fettig | Owner |
Responsible Party: | Vevazz, LLC |
ClinicalTrials.gov Identifier: | NCT03242564 |
Other Study ID Numbers: |
Vev-2017-1 |
First Posted: | August 8, 2017 Key Record Dates |
Last Update Posted: | August 8, 2017 |
Last Verified: | August 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Plan Description: | No current plan to share data. |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | Yes |
Product Manufactured in and Exported from the U.S.: | Yes |