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Clinical Trials/NCT04343586
NCT04343586CompletedNot Applicable

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

Northwestern University1 site in 1 country11 target enrollmentStarted: September 1, 2020Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
11
Locations
1
Primary Endpoint
Assess User Experience With the Dermatology Life Quality Index (DLQI) Pre and Post-treatment.

Study Overview

Brief Summary

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

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 89 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

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

Exclusion Criteria

  • •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.

Arms & Interventions

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.

Intervention: Blue light phototherapy (Device)

Outcomes

Primary Outcomes

Assess User Experience With the Dermatology Life Quality Index (DLQI) Pre and Post-treatment.

Time Frame: Time Frame: 5 weeks

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.

Efficacy of Blue Light Therapy for Patients With Grover's Disease

Time Frame: Time Frame: 5 weeks

Demonstrate preliminary skin efficacy as measured by lesion count

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Shuai (Steve) Xu

Principal Investigator

Northwestern University

Study Sites (1)

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