Clinical trial NCT05391178: Improving Disease Severity
Official title: Improving Disease Severity in Alopecia Areata, Polymorphous Light Eruption, and Psoriasis Patients With Lumiton Technology
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Psoriasis
Alopecia Areata
Polymorphous Light Eruption
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2022-05-25
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention 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
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Disease severity - photo
timeFrame: Baseline
measure: Disease severity - photo
timeFrame: Week 12
measure: Disease severity - PASI
timeFrame: Baseline
measure: Disease severity - PASI
timeFrame: Week 12
measure: Disease severity - SALT
timeFrame: Baseline
measure: Disease severity - SALT
timeFrame: Week 12
Secondary outcomes:
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences, Dermatology
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Joseph Jorizzo, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Barros NM, Sbroglio LL, Buffara MO, Baka JLCES, Pessoa AS, Azulay-Abulafia L. Phototherapy. An Bras Dermatol. 2021 Jul-Aug;96(4):397-407. doi: 10.1016/j.abd.2021.03.001. Epub 2021 Apr 2.
citation: Tsai SR, Hamblin MR. Biological effects and medical applications of infrared radiation. J Photochem Photobiol B. 2017 May;170:197-207. doi: 10.1016/j.jphotobiol.2017.04.014. Epub 2017 Apr 13.
citation: Toyokawa H, Matsui Y, Uhara J, Tsuchiya H, Teshima S, Nakanishi H, Kwon AH, Azuma Y, Nagaoka T, Ogawa T, Kamiyama Y. Promotive effects of far-infrared ray on full-thickness skin wound healing in rats. Exp Biol Med (Maywood). 2003 Jun;228(6):724-9. doi: 10.1177/153537020322800612.
citation: Chung J, Lee S. Development of nanofibrous membranes with far-infrared radiation and their antimicrobial properties. Fibers and Polymers. 2014;15(6).