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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04525573
• Other study ID #: CP20-01
• Status: Withdrawn
• Start date: August 7, 2020
• Est. completion date: December 31, 2021

Study information

• Verified date: July 2022
• Source: Ward Photonics LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.)

Related Conditions & MeSH terms

• Body Image
• Diabetes Mellitus, Type 2

Intervention

Device:
• LLLT Combination Red/Gold/IR Therapy
Three LLLT combination treatments per week over the course of two consecutive weeks, and a final follow up on day-15 (total of 7 treatments).

Locations

Country	Name	City	State
United States	Horizon Medical Center	Schaumburg	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Ward Photonics LLC

Country where clinical trial is conducted

United States, 

References & Publications (11)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Epub 2007 May 1. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fat Reduction	Circumferential reduction of fat as measured around the observation areas of the body.	15 days
Secondary	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