Improving Disease Severity

Study Overview
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Brief Summary
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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.

Detailed Description
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Recent advancements in nanotechnology have led to the development of medical devices (lasers and LED devices) with unique phototherapy properties that emit radiation in the infrared wavelengths, allowing patients to benefit from the effects of phototherapy treatment in a more convenient way. Preclinical studies demonstrated the positive effects of infrared radiation exposure on the skin including, increased collagen synthesis and expression of transforming growth factor-beta1 (TGF-beta1). Other studies suggested possible antimicrobial effects from infrared radiation, with decreased colonization of Staphylococcus aureus, Escherichia coli, and Klebsiella pneumoniae on the skin after exposure. Compared to other fabric technology, such as Far-Infrared (FIR) fabric technology that reflects body heat, fabric made from Lumiton yarn converts external light in the UV and visible spectrum and emits light in the red and near-infrared spectrum for the body. Lumiton yarn absorbs energy from 350 nm to 600 nm (the light spectrum from UV to visible red light) and emit energy from 600 to 1000 nm (red, near-infrared spectrum). The Lumiton yarn contains red/NIR light-emitting dyes. The effectiveness of the technology is proportional to the intensity of the light, with its peak effectiveness under sunlight.

Official Title
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Improving Disease Severity in Alopecia Areata, Polymorphous Light Eruption, and Psoriasis Patients With Lumiton Technology

Conditions
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Psoriasis, Alopecia Areata, Polymorphous Light Eruption

Intervention / Treatment
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* Other: Lumiton yarn sleeve
* Other: Lumiton yarn hat
* Other: Lumiton yarn shirt


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult participants ≥18 years of age Participants who live in the US, Participants who are diagnosed with mild-to-severe AA, PMLE, or psoriasis Participants have sufficient command of the English language Exclusion Criteria: Participants less than the age of 18 Participants who do not live in the US Participants who are not diagnosed with mild to severe AA, PMLE, or psoriasis Participants without a sufficient command of the English language Participants with concurrent medical conditions that are at risk of confounding the study outcomes Participants currently using concomitant phototherapy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A 12-week prospective pilot study involving a total of 15 patients, including five patients diagnosed with alopecia areata (AA), five patients diagnosed with polymorphous light eruption (PMLE), and five patients diagnosed with psoriasis
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Psoriasis<br>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. | Other: Lumiton yarn sleeve<br>* Sleeve made from patented technology embedded in synthetic yarns that harnesses the sun's energy and generates red and near-infrared light - elevating apparel<br>|
| Active Comparator: Alopecia Areata<br>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. | Other: Lumiton yarn hat<br>* Hat made from patented technology embedded in synthetic yarns that harnesses the sun's energy and generates red and near-infrared light - elevating apparel<br>|
| Active Comparator: Polymorphous Light Eruption<br>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. | Other: Lumiton yarn shirt<br>* Shirt made from patented technology embedded in synthetic yarns that harnesses the sun's energy and generates red and near-infrared light - elevating apparel<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease severity - photo | Lesion photos | Baseline | 
| Disease severity - photo | Lesion photos | Week 12 | 
| Disease severity - PASI | Psoriasis Area and Severity Index-75 (PASI-75%) scores The percentage area affected by psoriasis is evaluated in the four regions of the body. In each region, the area is expressed as nil (0), 1-9% (score 1), 10-29% (score 2), 30-49% (score 3), 50-69% (score 4), 70-89% (score 5) or 90-100% (score 6). | Baseline | 
| Disease severity - PASI | Psoriasis Area and Severity Index-75 (PASI-75%) scores The percentage area affected by psoriasis is evaluated in the four regions of the body. In each region, the area is expressed as nil (0), 1-9% (score 1), 10-29% (score 2), 30-49% (score 3), 50-69% (score 4), 70-89% (score 5) or 90-100% (score 6). | Week 12 | 
| Disease severity - SALT | Severity of Alopecia Tool (SALT) score The SALT score is computed by measuring the percentage of hair loss in each of 4 areas of the scalp-vertex (40%), right profile (18%), left profile (18%), and posterior (24%)-and adding the total to achieve a composite score. | Baseline | 
| Disease severity - SALT | Severity of Alopecia Tool (SALT) score The SALT score is computed by measuring the percentage of hair loss in each of 4 areas of the scalp-vertex (40%), right profile (18%), left profile (18%), and posterior (24%)-and adding the total to achieve a composite score. | Week 12 |