Blue Light Phototherapy

Psoriasis Vulgaris Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04343586
• Other study ID #: STU00210472
• Status: Completed
• Phase: N/A
• Start date: September 1, 2020
• Est. completion date: September 22, 2022

Study information

• Verified date: February 2023
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: September 22, 2022
• Est. primary completion date: December 20, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

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.

Related Conditions & MeSH terms

• Grover's Disease
• Psoriasis
• Psoriasis Vulgaris

Intervention

Device:
• Blue light phototherapy
Phototherapy- Wavelength: 417±15 nm

Locations

Country	Name	City	State
United States	Northwestern University Department of Dermatology	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Northwestern University	T-Cellerate LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy of Blue Light Therapy for Patients With Grover's Disease	Demonstrate preliminary skin efficacy as measured by lesion count	Time Frame: 5 weeks
Primary	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