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Effects of Red Light LED Therapy on Body Contouring

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ClinicalTrials.gov Identifier: NCT03470272
Recruitment Status : Not yet recruiting
First Posted : March 19, 2018
Last Update Posted : August 17, 2018
Sponsor:
Information provided by (Responsible Party):
Manamed Inc.

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Obesity Device: FB Professional LED Red light therapy Device: Effects of Red Light LED Therapy on Body Contouring Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 66 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Red Light LED Therapy on Body Contouring
Estimated Study Start Date : September 30, 2018
Estimated Primary Completion Date : November 30, 2018
Estimated Study Completion Date : November 30, 2018

Arm Intervention/treatment
Experimental: Active Device

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.

Device: FB Professional LED Red light therapy
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.
Other Name: Effects of Red Light LED Therapy on Body Contouring

Device: Effects of Red Light LED Therapy on Body Contouring
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.




Primary Outcome Measures :
  1. 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.



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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
Criteria

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.

Information from the National Library of Medicine

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): NCT03470272


Contacts
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Contact: Mark Julian 7276419399 glacierheat1@gmail.com

Locations
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United States, Florida
Ligertwood Chiropractic Enrolling by invitation
New Port Richey, Florida, United States, 34654
Sponsors and Collaborators
Manamed Inc.
Investigators
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Principal Investigator: Paul Ligertwood, Dr Human Studies Group

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Responsible Party: Manamed Inc.
ClinicalTrials.gov Identifier: NCT03470272     History of Changes
Other Study ID Numbers: Manamed
First Posted: March 19, 2018    Key Record Dates
Last Update Posted: August 17, 2018
Last Verified: August 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Product Manufactured in and Exported from the U.S.: No