Effects of a Red/Gold/IR LED Combination Light on Reduction of Fat

Withdrawn

• Conditions: Body Image; Diabetes Mellitus, Type 2

• Registration Number: NCT04525573
• Lead Sponsor: Ward Photonics LLC

Brief Summary

An open-label evaluation of the effects of a red/gold/IR LED combination light on reduction of fat. The results shall be compared to previous results from a comparator device utilizing only red LED monotherapy for the non-invasive reduction in fat layer for body contouring.

Detailed Description

The combination of gold/red/IR light is theorized to enhance the effect of the deeper penetrating red/IR light with the photomodulated effects of gold light. The light is positioned alongside the patient as they lay, or sit on a treatment table. A light panel is mounted to an articulating arm for positioning the light at the correct treatment position above the patient (non-contact). The effects of a red/gold/IR combination LED light therapy device on circumferential reduction of fat will be measured, and the overall health of the patients will be monitored using blood tests.

Study Timeline

• Study Start: 2020-08-07
• Study First Submitted: 2020-08-20
• Study First Submitted QC: 2020-08-20
• Study First Posted: 2020-08-25
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-13
• Last Update Posted: 2022-07-18

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Study participant is 18 years of age or older.
• Diagnosed with adult-onset (type 2) diabetes.
• Obesity

Exclusion Criteria

• Photosensitive condition or medication.
• Active chemotherapy treatment or other cancer treatment.
• Pregnant, possibly pregnant or planning pregnancy prior to the end of study participation.
• Developmental disability or cognitive impairment that, in the opinion of the investigator, would preclude adequate comprehension of the informed consent form and/or ability to record the necessary study measurements.
• Chronic stomach conditions (IBS, Crohn's, Ulcerative Colitis, etc.)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Fat Reduction	15 days	Circumferential reduction of fat as measured around the observation areas of the body.

Secondary Outcome Measures

Name	Time	Method
General Health Improvement	15 days	The secondary outcome of this study is to monitor patient health changes during the treatment period. The principal method for monitoring patient health is through blood testing. There is some evidence in literature that patients undergoing fat reduction benefit from secondary effects associated with their general health.

Trial Locations

Locations (1)

Horizon Medical Center; 🇺🇸 Schaumburg, Illinois, United States