NCT03470272

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
66

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Sep 2018

Shorter than P25 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 14, 2017

Completed
3 months until next milestone

First Posted

Study publicly available on registry

March 19, 2018

Completed
7 months until next milestone

Study Start

First participant enrolled

September 30, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2018

Completed
Last Updated

August 17, 2018

Status Verified

August 1, 2018

Enrollment Period

2 months

First QC Date

December 14, 2017

Last Update Submit

August 15, 2018

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Active Device

EXPERIMENTAL

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 therapyDevice: Effects of Red Light LED Therapy on Body Contouring

Interventions

FB Professional LED Red light therapyDEVICE

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.

Also known as: Effects of Red Light LED Therapy on Body Contouring
Active Device
Effects of Red Light LED Therapy on Body ContouringDEVICE

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.

Active Device

Eligibility Criteria

Age18 Years - 77 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • At least 18 years or older.
  • May be male or female.
  • Generally good health.

You may not qualify if:

  • Minors.
  • Open wounds or sores.
  • Pacemaker.
  • Photosensitivity.
  • Epilepsy.
  • Any form of cancer.
  • Severe kidney or liver problems.
  • Thyroid problems.
  • Pregnant or nursing.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ligertwood Chiropractic

New Port Richey, Florida, 34654, United States

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Paul Ligertwood, Dr

    Human Studies Group

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mark Julian

CONTACT

7276419399glacierheat1@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 14, 2017

First Posted

March 19, 2018

Study Start

September 30, 2018

Primary Completion

November 30, 2018

Study Completion

November 30, 2018

Last Updated

August 17, 2018

Record last verified: 2018-08

Locations

US(1)