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Improving Disease Severity

Primary Purpose

Psoriasis, Alopecia Areata, Polymorphous Light Eruption

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Lumiton yarn sleeve
Lumiton yarn hat
Lumiton yarn shirt
Sponsored by
Wake Forest University Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Psoriasis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Wake Forest University Health Sciences, DermatologyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Psoriasis

Alopecia Areata

Polymorphous Light Eruption

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Disease severity - photo
Lesion photos
Disease severity - photo
Lesion photos
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).
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).
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.
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.

Secondary Outcome Measures

Full Information

First Posted
May 20, 2022
Last Updated
June 29, 2023
Sponsor
Wake Forest University Health Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT05391178
Brief Title
Improving Disease Severity
Official Title
Improving Disease Severity in Alopecia Areata, Polymorphous Light Eruption, and Psoriasis Patients With Lumiton Technology
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 9, 2022 (Actual)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
November 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis, Alopecia Areata, Polymorphous Light Eruption

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Non-Randomized
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Psoriasis
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Alopecia Areata
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Polymorphous Light Eruption
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Lumiton yarn sleeve
Intervention Description
Sleeve made from patented technology embedded in synthetic yarns that harnesses the sun's energy and generates red and near-infrared light - elevating apparel
Intervention Type
Other
Intervention Name(s)
Lumiton yarn hat
Intervention Description
Hat made from patented technology embedded in synthetic yarns that harnesses the sun's energy and generates red and near-infrared light - elevating apparel
Intervention Type
Other
Intervention Name(s)
Lumiton yarn shirt
Intervention Description
Shirt made from patented technology embedded in synthetic yarns that harnesses the sun's energy and generates red and near-infrared light - elevating apparel
Primary Outcome Measure Information:
Title
Disease severity - photo
Description
Lesion photos
Time Frame
Baseline
Title
Disease severity - photo
Description
Lesion photos
Time Frame
Week 12
Title
Disease severity - PASI
Description
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).
Time Frame
Baseline
Title
Disease severity - PASI
Description
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).
Time Frame
Week 12
Title
Disease severity - SALT
Description
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.
Time Frame
Baseline
Title
Disease severity - SALT
Description
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.
Time Frame
Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Irma M Richardson, MHA
Phone
336-716-2903
Email
irichard@wakehealth.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph Jorizzo, M.D.
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wake Forest University Health Sciences, Dermatology
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Irma M Richardson, MHA
Phone
336-716-2903
Email
irichard@wakehealth.edu
First Name & Middle Initial & Last Name & Degree
Joseph Jorizzo, MD

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
This is pilot research, there is no decision to share individual participant data
Citations:
PubMed Identifier
33849754
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.
Results Reference
background
PubMed Identifier
28441605
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.
Results Reference
background
PubMed Identifier
12773705
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.
Results Reference
background
Citation
Chung J, Lee S. Development of nanofibrous membranes with far-infrared radiation and their antimicrobial properties. Fibers and Polymers. 2014;15(6).
Results Reference
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Improving Disease Severity

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