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

Trial Summary

What is the purpose of this trial?

This study evaluates 670 nm energy in the form of red light to stimulate blood flow changes in healthy adults. All participants will receive red light to their leg. They will also receive a continuous infusion of Definity (octafluoropropane) ultrasound contrast.

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.

What data supports the effectiveness of the treatment Red Light Therapy for Artificial Light Exposure?

Research shows that red light, used in photodynamic therapy (PDT), can effectively treat non-melanoma skin cancers by activating certain drugs that target cancer cells. This suggests that red light therapy may have potential benefits for other conditions involving light exposure. ^{1 2 3 4 5}

Is red light therapy generally safe for humans?

Red light therapy, also known as low-level light therapy (LLLT), is considered safe for humans and has been used for various conditions like skin improvement, wound healing, and pain relief. It has been cleared for cosmetic and therapeutic uses in several countries, and studies have shown it to be effective without significant safety concerns. ^{6 7 8 9 10}

How is Red Light Therapy for Artificial Light Exposure different from other treatments?

Red Light Therapy, using 670 nm light, is unique because it involves photobiomodulation, which enhances cell energy production and reduces oxidative stress, unlike traditional treatments that may not target these cellular processes. This therapy is non-invasive and uses specific light wavelengths to stimulate healing and reduce inflammation, making it distinct from other treatments that might rely on medication or more invasive procedures. ^{6 8 9 10 11}

Research Team

Nicole L Lohr, MD, PhD

Principal Investigator

Medical College of Wisconsin

Eligibility Criteria

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.

I am over 18 and in good health.

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 (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]

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]

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]

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 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]

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

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

2. England pubmed.ncbi.nlm.nih.gov

Low-irradiance red LED traffic lamps as light source in PDT for actinic keratoses. [2013]

3. United States pubmed.ncbi.nlm.nih.gov

Clinical and preclinical photodynamic therapy. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Increasing damage to tumor blood vessels during motexafin lutetium-PDT through use of low fluence rate. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Photodynamic therapy: the state of the art. [2019]

6. United States 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. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Low Level Light Therapy with Light-Emitting Diodes for the Aging Face. [2018]

8. England pubmed.ncbi.nlm.nih.gov

Developments in low level light therapy (LLLT) for dentistry. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Wound Phototherapy. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

Effect of pulsing in low-level light therapy. [2021]

11. England pubmed.ncbi.nlm.nih.gov

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