Blue Light Phototherapy

NCT ID: NCT04343586

Last Updated: 2023-03-17

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-01

Study Completion Date

2022-09-22

Brief Summary

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

Detailed Description

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Conditions

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Grover's Disease Psoriasis Vulgaris

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Blue light phototherapy

Intervention Type DEVICE

Phototherapy- Wavelength: 417±15 nm

Interventions

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Blue light phototherapy

Phototherapy- Wavelength: 417±15 nm

Intervention Type DEVICE

Other Intervention Names

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DusaPharma Blu-U model 4170

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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T-Cellerate LLC

INDUSTRY

Sponsor Role collaborator

Northwestern University

OTHER

Sponsor Role lead

Responsible Party

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Shuai (Steve) Xu

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Shuai Xu

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Locations

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Northwestern University Department of Dermatology

Chicago, Illinois, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 36449285 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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STU00210472

Identifier Type: -

Identifier Source: org_study_id

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