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

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.

Study Overview

• Status: Withdrawn
• Conditions: Diabetes Mellitus, Type 2; Body Image
• Intervention / Treatment: Device: LLLT Combination Red/Gold/IR Therapy

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 Type: Observational

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Schaumburg, Illinois, United States, 60173
      • Horizon Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Men and women over the age of 18 and with diagnosed Type 2 diabetes who are seeking fat loss.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fat Reduction	Circumferential reduction of fat as measured around the observation areas of the body.	15 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
General Health Improvement	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.	15 days

Collaborators and Investigators

• Sponsor: Ward Photonics LLC
• Investigators: Principal Investigator: Ahsaraf Dabawala, MD, Horizon Medical Center

Publications and helpful links

General Publications

• Sadick NS. A study to determine the efficacy of a novel handheld light-emitting diode device in the treatment of photoaged skin. J Cosmet Dermatol. 2008 Dec;7(4):263-7. doi: 10.1111/j.1473-2165.2008.00404.x.
• Opel DR, Hagstrom E, Pace AK, Sisto K, Hirano-Ali SA, Desai S, Swan J. Light-emitting Diodes: A Brief Review and Clinical Experience. J Clin Aesthet Dermatol. 2015 Jun;8(6):36-44.
• Lee SY, Park KH, Choi JW, Kwon JK, Lee DR, Shin MS, Lee JS, You CE, Park MY. A prospective, randomized, placebo-controlled, double-blinded, and split-face clinical study on LED phototherapy for skin rejuvenation: clinical, profilometric, histologic, ultrastructural, and biochemical evaluations and comparison of three different treatment settings. J Photochem Photobiol B. 2007 Jul 27;88(1):51-67. doi: 10.1016/j.jphotobiol.2007.04.008. Epub 2007 May 1.
• Goldberg DJ, Amin S, Russell BA, Phelps R, Kellett N, Reilly LA. Combined 633-nm and 830-nm led treatment of photoaging skin. J Drugs Dermatol. 2006 Sep;5(8):748-53.
• Baez F, Reilly LR. The use of light-emitting diode therapy in the treatment of photoaged skin. J Cosmet Dermatol. 2007 Sep;6(3):189-94. doi: 10.1111/j.1473-2165.2007.00329.x.
• Russell BA, Kellett N, Reilly LR. A study to determine the efficacy of combination LED light therapy (633 nm and 830 nm) in facial skin rejuvenation. J Cosmet Laser Ther. 2005 Dec;7(3-4):196-200. doi: 10.1080/14764170500370059.
• Lee SY, You CE, Park MY. Blue and red light combination LED phototherapy for acne vulgaris in patients with skin phototype IV. Lasers Surg Med. 2007 Feb;39(2):180-8. doi: 10.1002/lsm.20412.
• Goldberg DJ, Russell BA. Combination blue (415 nm) and red (633 nm) LED phototherapy in the treatment of mild to severe acne vulgaris. J Cosmet Laser Ther. 2006 Jun;8(2):71-5. doi: 10.1080/14764170600735912.
• Sadick N. A study to determine the effect of combination blue (415 nm) and near-infrared (830 nm) light-emitting diode (LED) therapy for moderate acne vulgaris. J Cosmet Laser Ther. 2009 Jun;11(2):125-8. doi: 10.1080/14764170902777349.
• Kwon HH, Lee JB, Yoon JY, Park SY, Ryu HH, Park BM, Kim YJ, Suh DH. The clinical and histological effect of home-use, combination blue-red LED phototherapy for mild-to-moderate acne vulgaris in Korean patients: a double-blind, randomized controlled trial. Br J Dermatol. 2013 May;168(5):1088-94. doi: 10.1111/bjd.12186.
• Ablon G. Combination 830-nm and 633-nm light-emitting diode phototherapy shows promise in the treatment of recalcitrant psoriasis: preliminary findings. Photomed Laser Surg. 2010 Feb;28(1):141-6. doi: 10.1089/pho.2009.2484.

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 7, 2020
• Primary Completion (ANTICIPATED): December 31, 2021
• Study Completion (ANTICIPATED): December 31, 2021

Study Registration Dates

• First Submitted: August 20, 2020
• First Submitted That Met QC Criteria: August 20, 2020
• First Posted (ACTUAL): August 25, 2020

Study Record Updates

• Last Update Posted (ACTUAL): July 18, 2022
• Last Update Submitted That Met QC Criteria: July 13, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: CP20-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: The study is an open-label evaluation of the effects of a red/gold/IR LED combination light on reduction of fat. And general health of the patients will be monitored as a possible correlation with fat reduction. However, the findings from this study are intended to explore whether a larger comparative study should be conducted.

Drug and device information, study documents

• 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