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Narrowband UVB Phototherapy in the Treatment of Psoriasis Vulgaris

NCT ID: NCT00844363

Last Updated: 2011-06-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-30

Study Completion Date

2011-05-31

Brief Summary

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Ultra-violet light B (UVB) therapy has been used by dermatologists to treat psoriasis for decades. Only a few studies have begun to dissect the mechanism of how NB-UVB therapy causes lesion resolution. Results from this study will aid in identifying other diseases that may be treated successfully with NB-UVB. If we can identify the mechanism of action of this therapy, this may give us additional new therapeutic targets for psoriasis and other diseases. Our overall hypothesis is that UVB induces changes that will indicate a mechanism of action of this therapy in psoriasis.

Detailed Description

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Conditions

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Chronic Plaque Psoriasis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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NB-UVB

Regular, monitored NB-UVB treatment. Patients will be treated 3 times per week, and a full course of therapy is 12 weeks. NB-UVB dosing is increased by 5-20% increments in exposure time, depending on response of the patient.

Group Type OTHER

NB-UVB

Intervention Type PROCEDURE

UVB light will be administered to the entire body except for the genitals in men and eyelids, which will be shielded.NB-UVB dosing is increased by 5-20% increments in exposure time, depending on response of the patient.

Interventions

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NB-UVB

UVB light will be administered to the entire body except for the genitals in men and eyelids, which will be shielded.NB-UVB dosing is increased by 5-20% increments in exposure time, depending on response of the patient.

Intervention Type PROCEDURE

Other Intervention Names

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narrowband UVB phototherapy

Eligibility Criteria

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Inclusion Criteria

* Signed informed consent.
* History of chronic plaque psoriasis vulgaris, for at least six months.
* ≥10% body surface affected
* Age 18 or greater.
* Concomitant, chronic, but well-controlled medical conditions such as hypertension are allowable.
* No treatment with topical steroids for at least 2 weeks prior to entering the study
* No treatment with systemic therapies, including etretinate, UVB, PUVA, or cyclosporine, other biologics 4 weeks prior to entering the study. However, if a patient is considered to be "unstable", or would deteriorate clinically if the systemic agent is ceased (eg efalizumab), a shorter "washout" period may be considered, and would be documented in the patient charts.
* Patients who receive a stable dose of methotrexate (defined as \<15mg/week for 4 months or greater) for psoriatic arthritis may be included.

Exclusion Criteria

* Subjects who do not meet the above criteria, or who meet any of the following criteria:

* Guttate, erythrodermic, or pustular psoriasis as sole or predominant form of psoriasis.
* PHOTOSENSITIVITY: Hypersensitivity to sunlight or UVB light of any type; history of Lupus, PMLE, or any disease known to be worsened by UV light exposure
* A history of non-melanoma skin cancer may be acceptable, and in this situation, the patient will be carefully evaluated.
* Poorly controlled medical conditions of any kind.
* Any medical condition that, in the opinion of the Investigator, would jeopardize the health or well being of the patient during the course of this study.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Doris Duke Charitable Foundation

OTHER

Sponsor Role collaborator

Rockefeller University

OTHER

Sponsor Role lead

Responsible Party

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Rockefeller University

Principal Investigators

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Michelle Lowes, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Rockefeller University

Locations

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Rockefeller University

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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MLO-0651

Identifier Type: -

Identifier Source: org_study_id