Effects of Red Light LED Therapy on Body Contouring

• ClinicalTrials.gov Identifier: NCT03470272
• Recruitment Status: Unknown
• First Posted: March 19, 2018
• Last Update Posted: August 17, 2018
• Sponsor: Manamed Inc.
• Information provided by (Responsible Party): Manamed Inc.

Tracking Information

• First Submitted Date: December 14, 2017
• First Posted Date: March 19, 2018
• Last Update Posted Date: August 17, 2018
• Estimated Study Start Date: September 30, 2018
• Estimated Primary Completion Date: November 30, 2018 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Effects of Red Light LED Therapy on Body Contouring
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Obesity

Intervention

• 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

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

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: March 16, 2018): 66
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: November 30, 2018
• Estimated Primary Completion Date: November 30, 2018 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 77 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03470272
• Other Study ID Numbers: 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: Not Provided
• Current Responsible Party: Manamed Inc.
• Original Responsible Party: Same as current
• Current Study Sponsor: Manamed Inc.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Paul Ligertwood, Dr; Human Studies Group

• PRS Account: Manamed Inc.
• Verification Date: August 2018