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Effects of Red Light LED Therapy on Body Contouring

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03470272
Recruitment Status : Unknown
Verified August 2018 by Manamed Inc..
Recruitment status was:  Not yet recruiting
First Posted : March 19, 2018
Last Update Posted : August 17, 2018
Sponsor:
Information provided by (Responsible Party):
Manamed Inc.

Tracking Information
First Submitted Date  ICMJE December 14, 2017
First Posted Date  ICMJE March 19, 2018
Last Update Posted Date August 17, 2018
Estimated Study Start Date  ICMJE September 30, 2018
Estimated Primary Completion Date November 30, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 16, 2018)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Red Light LED Therapy on Body Contouring
Official Title  ICMJE Effects of Red Light LED Therapy on Body Contouring
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Obesity
Intervention  ICMJE
  • 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.
Study Arms  ICMJE 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.

Interventions:
  • Device: FB Professional LED Red light therapy
  • Device: Effects of Red Light LED Therapy on Body Contouring
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: March 16, 2018)
66
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 30, 2018
Estimated Primary Completion Date November 30, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 77 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03470272
Other Study ID Numbers  ICMJE Manamed
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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.: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Manamed Inc.
Study Sponsor  ICMJE Manamed Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Paul Ligertwood, Dr Human Studies Group
PRS Account Manamed Inc.
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP