Blue Light Phototherapy

Recruiting at 1 trial location

Overseen By Dermatology CTU

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Northwestern University

Must not be taking: Topical steroids, Calcineurin inhibitors

Disqualifiers: Pregnancy, Prisoners, Vulnerable populations, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 5 weeks

11 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial will use a special blue light to treat people with psoriasis vulgaris and Grover's Disease. The blue light helps reduce skin inflammation and makes skin cells grow more normally. This treatment is aimed at improving skin conditions for these patients. Blue light has been shown to be effective in treating psoriasis and other skin conditions by reducing inflammation and promoting normal skin cell growth.

Will I have to stop taking my current medications?

Yes, you will need to stop taking certain medications. If you are using topical or systemic treatments for your skin condition, you must stop them at least 2 weeks before starting the trial. Also, if you are taking specific drugs like topical steroids, calcineurin inhibitors, methotrexate, retinoids, or biologic agents for other issues, you cannot participate in the trial.

What data supports the effectiveness of the treatment Blue Light Phototherapy?

Research shows that blue light phototherapy can have biological effects similar to ultraviolet A (UVA) radiation, which is used in dermatology to treat skin conditions. Additionally, studies comparing blue light to other light therapies suggest it can be effective in certain applications. ^{1 2 3 4 5}

How does blue light phototherapy differ from other treatments for neonatal jaundice?

Blue light phototherapy is unique because it uses specific wavelengths of light to transform bilirubin into a form that can be more easily eliminated from the body, making it effective for treating neonatal jaundice. Unlike other treatments, it specifically targets the blue spectrum of light, which is most effective for this purpose. ^{6 7 8 9 10}

Research Team

Shuai Xu

Principal Investigator

Northwestern University

Eligibility Criteria

Inclusion Criteria

You have been diagnosed with psoriasis vulgaris or Grover's disease in the past.

Patient's aged 18-89 at time of enrollment

Exclusion Criteria

Unable to schedule phototherapy sessions

You have used any medication or treatment for your skin condition within the past 2 weeks before starting phototherapy.

We will not recruit the following populations: adults unable to consent, individuals who are not yet adults (infants, children, teenagers), pregnant women, prisoners and other vulnerable populations.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive blue light phototherapy on affected areas for psoriasis or Grover's disease

5 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Long-term follow-up

Elucidate changes in circulatory T-cells based on flow cytometry and serum cytokines with blue light therapy

1 year

Treatment Details

Interventions

• Blue Light Phototherapy

Participant Groups

Group I: Adult treatment arm Experimental Treatment 1 Intervention

Adults enrolled in the study will receive treatment (blue light phototherapy) on one area of their body affected by psoriasis or Grover's disease. The treatment area (restricted by size of the device) will be compared to untreated areas affected by disease on the same patient.

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials

1,674

Recruited

989,000+

T-Cellerate LLC

Industry Sponsor

Trials

1

Recruited

10+

T-Cellerate LLC

Collaborator

Trials

1

Recruited

10+

Findings from Research

In a study involving 8 healthy volunteers, exposure to visible blue light over five consecutive days did not cause DNA damage or early signs of skin aging, indicating its safety for dermatological use.

The treatment resulted in transient melanogenesis, evidenced by a significant increase in Melan-A-positive cells, and caused vacuolization of keratinocytes, but did not lead to any inflammatory responses or apoptosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical and histological effects of blue light on normal skin. Kleinpenning, MM., Smits, T., Frunt, MH., et al.[2010]

References

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

The systemic effect of 830-nm LED phototherapy on the wound healing of burn injuries: A controlled study in mouse and rat models. [2012]

2. Norway pubmed.ncbi.nlm.nih.gov

Standardized bench method for evaluating the efficacy of phototherapy devices. [2019]

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

A prospective randomized controlled study of phototherapy using blue and blue-green light-emitting devices, and conventional halogen-quartz phototherapy. [2013]

4. England pubmed.ncbi.nlm.nih.gov

Clinical and histological effects of blue light on normal skin. [2010]

5. England pubmed.ncbi.nlm.nih.gov

Phototherapy with ultraviolet radiation: a study of hormone parameters and psychological effects. [2018]

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

Green light phototherapy in newborn infants with ABO hemolytic disease. [2019]

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

Neonatal blue light phototherapy and melanocytic nevi: a twin study. [2015]

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

Phototherapy for neonatal jaundice: optimal wavelengths of light. [2019]

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

Neonatal Blue Light Phototherapy and Melanocytic Nevus Count in Children: A Systematic Review and Meta-Analysis of Observational Studies. [2018]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Single-strand breaks in the DNA of human cells exposed to visible light from phototherapy lamps in the presence and absence of bilirubin. [2019]