Improving Disease Severity

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

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.

Study Overview

• Status: Recruiting
• Conditions: Psoriasis; Alopecia Areata; Polymorphous Light Eruption
• Intervention / Treatment: Other: Lumiton yarn sleeve; Other: Lumiton yarn hat; Other: Lumiton yarn shirt

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.

• Study Type: Interventional
• Enrollment (Estimated): 15
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Irma M Richardson, MHA; Phone Number: 336-716-2903; Email: irichard@wakehealth.edu

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Recruiting
      • Wake Forest University Health Sciences, Dermatology
      • Principal Investigator: Joseph Jorizzo, MD
      • Contact: Irma M Richardson, MHA; Phone Number: 336-716-2903; Email: irichard@wakehealth.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Psoriasis; 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; Sleeve made from patented technology embedded in synthetic yarns that harnesses the sun's energy and generates red and near-infrared light - elevating apparel
Active Comparator: Alopecia Areata; 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; Hat made from patented technology embedded in synthetic yarns that harnesses the sun's energy and generates red and near-infrared light - elevating apparel
Active Comparator: Polymorphous Light Eruption; 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; Shirt made from patented technology embedded in synthetic yarns that harnesses the sun's energy and generates red and near-infrared light - elevating apparel

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Investigators: Principal Investigator: Joseph Jorizzo, M.D., Wake Forest University Health Sciences

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• Chung J, Lee S. Development of nanofibrous membranes with far-infrared radiation and their antimicrobial properties. Fibers and Polymers. 2014;15(6).

Study record dates

Study Major Dates

• Study Start (Actual): August 9, 2022
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): September 1, 2024

Study Registration Dates

• First Submitted: May 20, 2022
• First Submitted That Met QC Criteria: May 20, 2022
• First Posted (Actual): May 25, 2022

Study Record Updates

• Last Update Posted (Actual): March 29, 2024
• Last Update Submitted That Met QC Criteria: March 27, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Pathological Conditions, Anatomical; Skin Diseases, Papulosquamous; Dermatitis; Skin Diseases, Eczematous; Hypotrichosis; Hair Diseases; Psoriasis; Exanthema; Dermatitis, Contact; Alopecia; Alopecia Areata
• Other Study ID Numbers: IRB00084854

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: This is pilot research, there is no decision to share individual participant data

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No