Effects of Red Light LED Therapy on Body Contouring

Obesity Clinical Trial

Official title:

Effects of Red Light LED Therapy on Body Contouring

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03470272
• Other study ID #: Manamed
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 30, 2018
• Est. completion date: November 30, 2018

Study information

• Verified date: August 2018
• Source: Manamed Inc.
• Contact: Mark Julian
• Phone: 7276419399
• Email: glacierheat1[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 66
• Est. completion date: November 30, 2018
• Est. primary completion date: November 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 77 Years

Eligibility

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.

Related Conditions & MeSH terms

• 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.
• 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.

Locations

Country	Name	City	State
United States	Ligertwood Chiropractic	New Port Richey	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Manamed Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Fat Amount (Reduction) in Treatment Area as Measured in Inches Lost	Circumferential measurement of thighs, hips and waist before and after treatment.	One 28 minute session