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

NCT04525573 | Withdrawn FDA Device

• 1 other identifier: CP20-01
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Body Image; Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• Fat Reduction

  Circumferential reduction of fat as measured around the observation areas of the body.

  15 days

Secondary Outcomes (1)

• General Health Improvement

  15 days

Interventions

LLLT Combination Red/Gold/IR Therapy DEVICE

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).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Ward Photonics LLC: lead

Study Sites (1)

Horizon Medical Center

Schaumburg, Illinois, 60173, United States

Location

Related Publications (11)

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  PMID: 26155326 BACKGROUND

• 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.

  PMID: 17566756 BACKGROUND

• 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.

  PMID: 16989189 BACKGROUND

• 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.

  PMID: 19146602 BACKGROUND

• 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.

  PMID: 17760698 BACKGROUND

• 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.

  PMID: 16414908 BACKGROUND

• 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.

  PMID: 17111415 BACKGROUND

• 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.

  PMID: 16766484 BACKGROUND

• 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.

  PMID: 19391058 BACKGROUND

• 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.

  PMID: 23278295 BACKGROUND

• 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.

  PMID: 19764893 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood Testing: * Glucose * CMP * A1c * Fructosamine * Lipids * Leptin * CRP

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Ahsaraf Dabawala, MD

  Horizon Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2020
• First Posted: August 25, 2020
• Study Start: August 7, 2020
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: July 18, 2022

Record last verified: 2022-07

Locations

US (1)