Effects of Red Light LED Therapy on Body Contouring

ManaMed

Status: Unknown

Conditions: Obesity

Treatments: Device: FB Professional LED Red light therapy; Device: Effects of Red Light LED Therapy on Body Contouring

Study type: Interventional

Funder types: Industry

Identifiers

NCT03470272

Manamed

Details and patient eligibility

About

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.

Full 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.

Enrollment: 66 estimated patients

Sex: All

Ages: 18 to 77 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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66 participants in 1 patient group

Active Device

Experimental group

Description:

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.

Treatment:

Device: Effects of Red Light LED Therapy on Body Contouring

Device: FB Professional LED Red light therapy