Phototherapy Garments for Psoriasis

Overseen By Irma M Richardson, MHA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Wake Forest University Health Sciences

Disqualifiers: Under 18, Non-US resident, others

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

Approved in 6 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

13 Participants Needed

Trial Summary

What is the purpose of this trial?

Phototherapy, including ultraviolet B (UVB) and ultraviolet A (UVA) light, has been used to treat a number of dermatologic conditions. Psoriasis is one of the most common conditions treated with phototherapy, in which phototherapy is often indicated for extensive disease with contraindications for other systemic treatments. The mechanism of action of phototherapy for the treatment of psoriasis is not completely understood; however, it is known that UVB light induces apoptosis of pathogenic T cells and keratinocytes, which may reduce the overactive immune response and epidermal hyperproliferation. Phototherapy has shown some efficacy for other diseases, such as alopecia areata (AA) and polymorphous light eruption (PMLE). However, phototherapy is not always an accessible treatment option for patients due to cost or lack of time.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, it does exclude participants who are currently using other forms of phototherapy.

What data supports the effectiveness of the treatment Phototherapy Garments for Psoriasis?

Research shows that heliotherapy (sunlight treatment) and UVB phototherapy are effective for psoriasis, with heliotherapy achieving a 94% improvement rate and UVB phototherapy an 86% improvement rate. Both treatments use ultraviolet light, which is a key component of phototherapy garments. ^{1 2 3 4 5}

Is phototherapy safe for treating psoriasis?

Phototherapy, including UVB light therapy, is considered one of the safest treatments for psoriasis, with many studies supporting its safety when used properly. ^{2 4 6 7 8}

How is phototherapy different from other treatments for psoriasis?

Phototherapy for psoriasis is unique because it uses ultraviolet light to treat the skin, which can be done with special garments, making it a non-invasive and natural option. Unlike some other treatments, it can be combined with other therapies and has few side effects, offering a safe and effective alternative. ^{1 2 6 9 10}

Research Team

Joseph Jorizzo, MD

Principal Investigator

Wake Forest University Health Sciences

Eligibility Criteria

This trial is for adults over 18 living in the US with mild-to-severe Alopecia Areata, Polymorphous Light Eruption, or psoriasis. They must speak English well enough to understand the study requirements. People under 18, without these specific conditions, not living in the US, or using other phototherapy treatments cannot join.

Inclusion Criteria

Participants who live in the US

Participants have sufficient command of the English language

I have been diagnosed with AA, PMLE, or psoriasis.

Exclusion Criteria

I am currently undergoing phototherapy treatment.

I am not fluent in English.

You have other health problems that could make it hard to understand the study results.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants wear Lumiton yarn garments daily for 12 weeks both indoors and outdoors

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Phototherapy

Trial Overview The trial is testing Lumiton yarn products (sleeve, hat, shirt) designed to provide a form of light therapy for skin conditions like psoriasis and alopecia. The goal is to see if wearing these clothes can help improve disease severity by mimicking beneficial effects of UV light treatment.

Participant Groups

Group I: Psoriasis Active Control 1 Intervention

Psoriasis participants will be provided sleeves made from the Lumiton yarn to cover their arms. The participants will be instructed to wear the sleeves made from Lumiton yarn daily for 12 weeks both indoors and outdoors.

Group II: Alopecia Areata Active Control 1 Intervention

Alopecia areata participants will be provided a hat made from the Lumiton yarn. The participants will be instructed to wear the hat made from Lumiton yarn daily for 12 weeks both indoors and outdoors.

Group III: Polymorphous Light Eruption Active Control 1 Intervention

Polymorphous light eruption participants will be provided a shirt made from the Lumiton yarn. The participants will be instructed to wear the shirt made from Lumiton yarn daily for 12 weeks both indoors and outdoors.

Phototherapy is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:

Approved in European Union as Phototherapy for:

• Psoriasis
• Eczema
• Vitiligo
• Neonatal Jaundice
• Seasonal Affective Disorder

Approved in United States as Phototherapy for:

• Psoriasis
• Eczema
• Vitiligo
• Neonatal Jaundice
• Seasonal Affective Disorder
• Shift Work Disorder

Approved in Canada as Phototherapy for:

• Psoriasis
• Eczema
• Vitiligo
• Neonatal Jaundice
• Seasonal Affective Disorder

Approved in Japan as Phototherapy for:

• Psoriasis
• Eczema
• Vitiligo
• Neonatal Jaundice

Approved in China as Phototherapy for:

• Psoriasis
• Eczema
• Vitiligo
• Neonatal Jaundice

Approved in Switzerland as Phototherapy for:

• Psoriasis
• Eczema
• Vitiligo
• Neonatal Jaundice
• Seasonal Affective Disorder

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

References

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

Effect of climate therapy at Gran Canaria on vitamin D production, blood glucose and lipids in patients with psoriasis. [2018]

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

Phototherapy: UVB and PUVA. [2013]

3. England pubmed.ncbi.nlm.nih.gov

Sun exposure induces rapid immunological changes in skin and peripheral blood in patients with psoriasis. [2011]

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

Comparison of the antipsoriatic efficacy of heliotherapy and ultraviolet B: a cross-over study. [2006]

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

Phototherapy in psoriasis: a review of mechanisms of action. [2022]

6. England pubmed.ncbi.nlm.nih.gov

The role of commercial tanning beds and ultraviolet A light in the treatment of psoriasis. [2006]

7. England pubmed.ncbi.nlm.nih.gov

Tanning beds as an alternative for psoriasis when office-based phototherapy is not accessible. [2009]

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

Ultraviolet B radiation therapy for psoriasis: Pursuing the optimal regime. [2017]

9. Germany pubmed.ncbi.nlm.nih.gov

Phototherapy: Theory and practice. [2023]

10. England pubmed.ncbi.nlm.nih.gov

Narrow-band ultraviolet B phototherapy versus broad-band ultraviolet B or psoralen-ultraviolet A photochemotherapy for psoriasis. [2018]