Red Light Therapy for Artificial Light Exposure

Overseen By Nicole L Lohr, MD, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Alabama at Birmingham

Disqualifiers: Cancer, Diabetes, Hypertension, Heart disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 visit

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if red light therapy (also known as photobiomodulation or low-level laser therapy) can improve blood flow in healthy adults. Participants will have their leg exposed to a specific type of red light and receive an ultrasound contrast to measure blood flow. This simple test evaluates whether the light can make a difference. Individuals who are generally healthy and do not have conditions like diabetes or heart issues may be suitable for this study. As an unphased trial, this study offers participants the chance to contribute to innovative research that could lead to new health insights.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that using 670 nm red light, like the one in this trial, is generally safe. Studies have found that red light therapy can improve blood flow and may even aid in brain injury recovery. This type of light is usually well-tolerated because it avoids the safety issues associated with lasers, making it easier and safer to use on large body areas.

Octafluoropropane is often used in medical imaging as a contrast agent. In this trial, it helps doctors see blood flow more clearly with ultrasound. Although detailed safety information is limited, it is commonly used in medical settings. Its use in this trial suggests a history of safety when used properly.

In summary, both treatments in this trial have evidence supporting their safety in humans. Red light therapy is known for being gentle, and octafluoropropane is a standard part of medical imaging. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the use of 670 nm red light therapy for artificial light exposure because it offers a unique, non-invasive approach by using a specific wavelength of light to improve blood flow. Unlike traditional treatments that might involve medication or lifestyle changes, this therapy uses a light-emitting diode positioned above the skin, avoiding direct contact and minimizing discomfort. Additionally, the treatment is paired with octafluoropropane infusion for precise blood flow measurement, allowing for real-time assessment of its effectiveness. This innovative method could provide a quicker, more targeted solution for issues caused by artificial light exposure.

What evidence suggests that red light therapy might be an effective treatment for stimulating blood flow changes?

Research has shown that 670 nm red light therapy, which participants in this trial will receive, can benefit several health areas. Studies have found it improves sleep and boosts endurance in athletes. It also protects eye cells, particularly those that detect light, preventing cell death. Additionally, a single session of 670 nm light can significantly enhance the ability to distinguish between colors. These findings suggest that 670 nm light therapy might also increase blood flow, given its positive effects on cell health and function. ^{1 3 6 7 8}

Who Is on the Research Team?

Nicole L Lohr, MD, PhD

Principal Investigator

Medical College of Wisconsin

Are You a Good Fit for This Trial?

This trial is for healthy adults aged 18-60, from any ethnic background. Participants must be able to understand and consent to the study in English. It's not suitable for those with heart or artery disease, high BMI, uncontrolled medical conditions, certain blood pressure levels, diabetes, kidney disease, neurological issues like stroke or cancer history.

Inclusion Criteria

I am either a man or a woman.

All ethnicities will be included in this study

Exclusion Criteria

I do not have any uncontrolled medical conditions.

Active pregnancy

I have a history of heart murmur or rhythm disorder.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 visit

Treatment

Participants receive 670 nm red light exposure to the gastrocnemius muscle with concurrent blood flow measurements using contrast ultrasound

1 visit

1 visit (in-person)

Follow-up

Participants are monitored post-procedure for safety and effectiveness

10 minutes

What Are the Treatments Tested in This Trial?

Interventions

• 670 nm light
• octafluropropane

Trial Overview

The study tests how red light at a wavelength of 670 nm affects blood flow when applied to the leg. Additionally, participants will receive an infusion of Definity (octafluoropropane) contrast agent during the procedure.

How Is the Trial Designed?

Group I: 670 nm light Experimental Treatment 2 Interventions

Subjects will have baseline blood flow measured in the gastrocnemius using octafluoropropane infusion and ultrasound.After baseline flow measurements are obtained, a 670 nm light emitting diode will be placed 1 cm above the gastrocnemius muscle. The diode will not be in direct contact with the skin. Subjects will be exposed to 75 mW/cm2. Contrast images will be obtained up to 5 minutes after the commencement of light.

670 nm light is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Red Light Therapy for:

• Age-related macular degeneration
• Retinal inflammation
• Uveitis

Approved in United States as Photobiomodulation for:

• Pain relief
• Wound healing
• Skin rejuvenation

Approved in Canada as Low-Level Laser Therapy (LLLT) for:

• Musculoskeletal pain
• Inflammatory conditions
• Wound healing

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

Medical College of Wisconsin

Lead Sponsor

Trials

645

Recruited

1,180,000+

Published Research Related to This Trial

Low-level light therapy (LLLT) has been shown to be effective for various skin conditions and wound healing, receiving clearance in the U.S. for cosmetic improvements and pain reduction, indicating its broad therapeutic potential.

Despite its widespread use, there is a lack of well-designed clinical trials that systematically evaluate the optimal parameters (like wavelength and energy dose) for LLLT, which can lead to confusion in its application for different types of wounds.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Wound Phototherapy. Bolton, LL.[2021]

Photodynamic therapy (PDT) effectively uses a photosensitizing drug activated by laser light for treating both cancer and non-cancer conditions, showcasing its versatility as a treatment option.

The report reviews clinical and preclinical studies involving Photofrin and other second-generation photosensitizers, highlighting advancements in the effectiveness and application of PDT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical and preclinical photodynamic therapy. Fisher, AM., Murphree, AL., Gomer, CJ.[2022]

Photodynamic therapy using red LED traffic lamps was effective in treating non-hypertrophic actinic keratoses in 15 patients, with all showing clinical improvement after just one session.

This method not only provided satisfactory results with minimal pain but also offers a cost-effective alternative to traditional, more complex photodynamic therapy light sources.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low-irradiance red LED traffic lamps as light source in PDT for actinic keratoses. Enk, CD., Levi, A.[2013]

Photodynamic therapy, using haematoporphyrin derivative activated by red light, shows promise as a treatment for localized malignant diseases, supported by extensive laboratory and clinical research.

Current clinical trials are yielding exciting results, and while future research may lead to improved sensitizers and light combinations, it will take several years before new options are available for clinical use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Photodynamic therapy: the state of the art. Carruth, JA.[2019]

Low-level light therapy (LLLT) has been shown to be a safe and effective treatment for skin rejuvenation, acne vulgaris, and body contouring, supported by a reasonable amount of clinical trial evidence.

Despite its commercial success, the quality of evidence for LLLT is limited by methodological flaws and small sample sizes, highlighting the need for more rigorous, independent clinical trials to validate its therapeutic benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Photobiomodulation: The Clinical Applications of Low-Level Light Therapy. Glass, GE.[2022]

Low level light therapy (LLLT) using LEDs has been scientifically validated as an effective treatment, particularly for enhancing skin health and blood flow, making it relevant for plastic surgery.

LLLT is considered a safe and effective standalone therapy, although patients may need to be patient to see the final results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low Level Light Therapy with Light-Emitting Diodes for the Aging Face. Calderhead, RG., Vasily, DB.[2018]

A Helium-Neon laser dose of 5 J/cm² significantly enhances the proliferation and migration of wounded human skin fibroblasts, promoting faster wound healing without causing cellular damage.

Higher doses of laser irradiation (10 and 16 J/cm²) negatively impact cell viability and increase cellular damage, indicating that the effects of laser therapy are highly dependent on the dosage used.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of laser fluence in cell viability, proliferation, and membrane integrity of wounded human skin fibroblasts following helium-neon laser irradiation. Hawkins, DH., Abrahamse, H.[2022]

Low level light/laser therapy (LLLT) shows promise for treating oral and dental disorders, with 130 out of 153 reviewed studies reporting positive effects such as pain relief and faster healing.

LLLT is considered a safe and novel approach for oral applications, suggesting it could address unmet clinical needs in dental care, although its use in this area has been limited compared to other medical fields.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Developments in low level light therapy (LLLT) for dentistry. Carroll, JD., Milward, MR., Cooper, PR., et al.[2022]

Photodynamic therapy (PDT) using methyl aminolaevulate (MAL) is an effective treatment for non-melanoma skin cancers (NMSC), as it activates photosensitizers that produce reactive singlet oxygen to destroy cancer cells.

MAL is now an approved drug in the EU, and its effectiveness is enhanced by using red light from various sources, including specialized lamps and LED arrays, which penetrate the skin well to activate the treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of light in the treatment of non-melanoma skin cancer using methyl aminolevulinate. Brown, SB.[2019]

Low level light therapy (LLLT) is effective for promoting wound healing, reducing pain and inflammation, and preventing tissue death, making it a valuable tool in various medical fields.

There is preliminary evidence suggesting that pulsed light may have distinct effects compared to continuous wave light, but more research is needed to clarify these differences and optimize treatment parameters for specific conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of pulsing in low-level light therapy. Hashmi, JT., Huang, YY., Sharma, SK., et al.[2021]

In this study, photodynamic therapy (PDT) using a low light fluence rate of 25 mW/cm² significantly improved long-term tumor responses compared to a higher rate of 75 mW/cm², despite not increasing oxygen saturation in tumors.

The lower fluence rate prolonged ischemic effects during treatment, leading to greater vascular damage and reduced survival of cancer cells, suggesting that optimizing light delivery can enhance the effectiveness of PDT in targeting tumor vasculature.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Increasing damage to tumor blood vessels during motexafin lutetium-PDT through use of low fluence rate. Busch, TM., Wang, HW., Wileyto, EP., et al.[2021]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC3499892/

Red Light and the Sleep Quality and Endurance Performance ...

The 14-day whole-body irradiation with red-light treatment improved the sleep, serum melatonin level, and endurance performance of the elite female basketball ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC6091542/

Photobiomodulation: Lasers vs Light Emitting Diodes? - PMC

It can also be interpreted that both groups showed improved wound closure, though the data regarding the noncoherent red light is not shown in the study report.

3.

onlinelibrary.wiley.com

onlinelibrary.wiley.com/doi/10.1155/2016/2734139

Efficacy of 670 nm Light Therapy to Protect against ...

Photobiomodulation at a wavelength of 670 nm has been shown to be effective in preventing photoreceptor cell death in the retina.

4.

nature.com

nature.com/articles/s41598-021-02311-1

Weeklong improved colour contrasts sensitivity after single ...

We show here that single 3 min 670 nm exposures, at much lower energies than previously used, are sufficient to significantly improve for 1 week cone mediated ...

5.

frontiersin.org

frontiersin.org/journals/neurology/articles/10.3389/fneur.2024.1398894/full

Can infrared light really be doing what we claim it is doing? ...

Near infrared (NIR) light has been shown to provide beneficial treatment of traumatic brain injury (TBI) and other neurological problems.

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11671386/

Photobiomodulation: shining a light on depression - PMC

Photobiomodulation (PBM), which involves the application of red or near-infrared light, modulates physiological processes by enhancing cerebral blood flow.

7.

academic.oup.com

academic.oup.com/asj/article/43/5/NP357/7018419

Photobiomodulation: A Systematic Review of the Oncologic ...

This article presents a summary of the clinical and preclinical evidence for the oncologic safety of PBM for aesthetic skin rejuvenation.

8.

sciencedirect.com

sciencedirect.com/science/article/pii/S1568163724000011

Phototherapy for age-related brain diseases

Research has shown that neuro-growth factor can be stimulated to induce neurite elongation through exposure to red light at 670 nm (Baratto et al., 2011).