Blue Light Phototherapy

NCT04343586 | Completed Results FDA Device

• 1 other identifier: STU00210472
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Grover's Disease; Psoriasis Vulgaris

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

Adult treatment arm

EXPERIMENTAL

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

Interventions

Blue light phototherapy DEVICE

Phototherapy- Wavelength: 417±15 nm

Also known as: DusaPharma Blu-U model 4170

Adult treatment arm

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Northwestern University: lead
• T-Cellerate LLC: collaborator

Study Sites (1)

Northwestern University Department of Dermatology

Chicago, Illinois, 60611, United States

Location

Related Publications (1)

• Olagbenro M, Ravi S, Myers D, Lin D, Woodburn W, Walter JR, Xu S. Assessment of Blue Light Phototherapy for Grover Disease: A Nonrandomized Controlled Trial. JAMA Dermatol. 2023 Jan 1;159(1):102-104. doi: 10.1001/jamadermatol.2022.4491.

  PMID: 36449285 DERIVED

MeSH Terms

Conditions

Grover's disease

Interventions

Phototherapy

Intervention Hierarchy (Ancestors)

Therapeutics

Results Point of Contact

• Title: Dermatology CTU
• Organization: Northwestern University

NUderm-research@northwestern.edu

312-503-5944

Study Officials

• Shuai Xu

  Northwestern University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 24, 2020
• First Posted: April 13, 2020
• Study Start: September 1, 2020
• Primary Completion: December 20, 2021
• Study Completion: September 22, 2022
• Last Updated: March 17, 2023
• Results First Posted: March 17, 2023

Record last verified: 2023-02

Locations

US (1)