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Blue Light Phototherapy

Primary Purpose

Grover's Disease, Psoriasis Vulgaris

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Blue light phototherapy

About this trial

This is an interventional treatment trial for Grover's Disease

Eligibility Criteria

18 Years - 89 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Northwestern University Department of Dermatology

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Adult treatment arm

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Demonstrate preliminary skin efficacy as measured by lesion count

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT04343586

First Posted

January 24, 2020

Last Updated

February 21, 2023

Sponsor

Northwestern University

Collaborators

T-Cellerate LLC

1. Study Identification

Unique Protocol Identification Number

NCT04343586

Brief Title

Blue Light Phototherapy

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Completed

Study Start Date

September 1, 2020 (Actual)

Primary Completion Date

December 20, 2021 (Actual)

Study Completion Date

September 22, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Northwestern University

Collaborators

T-Cellerate LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Data Monitoring Committee

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Grover's Disease, Psoriasis Vulgaris

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

11 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Adult treatment arm

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

Blue light phototherapy

Other Intervention Name(s)

DusaPharma Blu-U model 4170

Intervention Description

Phototherapy- Wavelength: 417±15 nm

Primary Outcome Measure Information:

Title

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

Description

Demonstrate preliminary skin efficacy as measured by lesion count

Time Frame

Time Frame: 5 weeks

Title

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

Description

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

Time Frame: 5 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

89 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Shuai Xu

Organizational Affiliation

Northwestern University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Northwestern University Department of Dermatology

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60611

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Blue Light Phototherapy

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