Improving Disease Severity

NCT05391178 | Completed

• 1 other identifier: IRB00084854
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Psoriasis; Alopecia Areata; Polymorphous Light Eruption

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (3)

Psoriasis

ACTIVE COMPARATOR

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

Alopecia Areata

ACTIVE COMPARATOR

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

Polymorphous Light Eruption

ACTIVE COMPARATOR

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

Interventions

Lumiton yarn sleeve OTHER

Sleeve made from patented technology embedded in synthetic yarns that harnesses the sun's energy and generates red and near-infrared light - elevating apparel

Psoriasis

Lumiton yarn hat OTHER

Hat made from patented technology embedded in synthetic yarns that harnesses the sun's energy and generates red and near-infrared light - elevating apparel

Alopecia Areata

Lumiton yarn shirt OTHER

Shirt made from patented technology embedded in synthetic yarns that harnesses the sun's energy and generates red and near-infrared light - elevating apparel

Polymorphous Light Eruption

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Wake Forest University Health Sciences, Dermatology

Winston-Salem, North Carolina, 27157, United States

Location

Related Publications (4)

• 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.

  PMID: 33849754 BACKGROUND

• 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.

  PMID: 28441605 BACKGROUND

• 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.

  PMID: 12773705 BACKGROUND

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

  BACKGROUND

MeSH Terms

Conditions

Psoriasis; Alopecia Areata

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; Alopecia; Hypotrichosis; Hair Diseases

Study Officials

• Joseph Jorizzo, M.D.

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: May 20, 2022
• First Posted: May 25, 2022
• Study Start: August 9, 2022
• Primary Completion: May 15, 2024
• Study Completion: May 15, 2024
• Last Updated: May 6, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)