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

NCT ID: NCT04525573

Last Updated: 2022-07-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2020-08-07

Study Completion Date

2021-12-31

Brief Summary

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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

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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.

Conditions

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Body Image Diabetes Mellitus, Type 2

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Interventions

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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).

Intervention Type DEVICE

Eligibility Criteria

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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.)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ward Photonics LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ahsaraf Dabawala, MD

Role: PRINCIPAL_INVESTIGATOR

Horizon Medical Center

Locations

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Horizon Medical Center

Schaumburg, Illinois, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 26155326 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17566756 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16989189 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19146602 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17760698 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16414908 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17111415 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16766484 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19391058 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23278295 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19764893 (View on PubMed)

Other Identifiers

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CP20-01

Identifier Type: -

Identifier Source: org_study_id

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