Blue Light Phototherapy

Development & Preliminary Clinical Validation Blue Light Phototherapy Systems for T-Cell

This study will use Blue-light Photo-therapy to treat patients with psoriasis vulgaris and Grover's Disease.

Study Overview

• Status: Completed
• Conditions: Psoriasis Vulgaris; Grover's Disease
• Intervention / Treatment: Device: Blue light phototherapy

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dermatology CTU; Phone Number: 312-503-5910; Email: DermSensors@northwestern.edu

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University Department of Dermatology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 89 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Patient's aged 18-89 at time of enrollment
2. Previous diagnosis of psoriasis vulgaris or Grover's disease

Exclusion Criteria:

1. All Groups: Subjects who are younger than 18 years of age or older than 90 years of age
2. Patients who have received topical or systemic treatment within the prior 2 weeks of planned phototherapy

3. Patients prescribed any of the following drugs for issues not related to their psoriasis or Grover's disease

   • topical steroids
   • calcineurin inhibitors
   • methotrexate
   • retinoids
   • biologic agents
4. Unable to schedule phototherapy sessions
5. We will not recruit the following populations: adults unable to consent, individuals who are not yet adults (infants, children, teenagers), pregnant women, prisoners and other vulnerable populations.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Adult treatment arm; Adults enrolled in the study will receive treatment (blue light phototherapy) on one area of their body affected by psoriasis or Grover's disease. The treatment area (restricted by size of the device) will be compared to untreated areas affected by disease on the same patient.	Device: Blue light phototherapy; Phototherapy- Wavelength: 417±15 nm; Other Names: DusaPharma Blu-U model 4170

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy of Blue Light Therapy for Patients With Grover's Disease	Demonstrate preliminary skin efficacy as measured by lesion count	Time Frame: 5 weeks
Assess User Experience With the Dermatology Life Quality Index (DLQI) Pre and Post-treatment.	The DLQI is a questionnaire with 10 questions. The maximum score is 30 and minimum is 0. The higher the score, the more quality of life is impaired.	Time Frame: 5 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cellular analysis of Blue light phototherapy	• Elucidate keratinocyte and skin T-cell expression, and viability with blue light phototherapy.	Time Frame: 1 year
Cellular analysis of Blue light phototherapy	Elucidate changes in circulatory T-cells based on flow cytometry and serum cytokines with blue light therapy.	Time Frame: 1 year

Collaborators and Investigators

• Sponsor: Northwestern University
• Collaborators: T-Cellerate LLC

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2020
• Primary Completion (Actual): December 20, 2021
• Study Completion (Actual): September 22, 2022

Study Registration Dates

• First Submitted: January 24, 2020
• First Submitted That Met QC Criteria: April 10, 2020
• First Posted (Actual): April 13, 2020

Study Record Updates

• Last Update Posted (Actual): March 17, 2023
• Last Update Submitted That Met QC Criteria: February 21, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis
• Other Study ID Numbers: STU00210472

Drug and device information, study documents

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