Narrowband UVB Phototherapy in the Treatment of Psoriasis Vulgaris

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00844363
Recruitment Status : Terminated (Unable to isolate sufficient cells from the skin biopsy to perform study related experiments)
First Posted : February 16, 2009
Last Update Posted : June 30, 2011
Doris Duke Charitable Foundation
Information provided by:
Rockefeller University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Chronic Plaque Psoriasis Procedure: NB-UVB Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Mechanism of Action of Narrowband UVB Phototherapy in the Treatment of Psoriasis Vulgaris
Study Start Date : November 2008
Actual Primary Completion Date : May 2011
Actual Study Completion Date : May 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis
U.S. FDA Resources

Arm Intervention/treatment
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.
Procedure: 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.
Other Name: narrowband UVB phototherapy

Primary Outcome Measures :
  1. The primary outcome is genomic analysis of lesional skin biopsies, in a time course experiment,by microarray and RT-PCR. [ Time Frame: End of study ]

Secondary Outcome Measures :
  1. cell counts of leukocytes populations in skin biopsies including (but not limited to) myeloid dendritic cells (CD11c and CD1c/BDCA-1), plasmacytoid dendritic cells (BDCA-2/CD123), macrophages (CD163), and T cells (CD3, CD4, CD8, Foxp3, RORγ). [ Time Frame: End of study ]
  2. Effects of NB-UVB on NL skin will be determined by comparison of microarray analysis of NL skin biopsies throughout treatment. [ Time Frame: End of study ]
  3. To determine if there is a set of genes that can predict response, expressed in circulating PBMCs, we will perform microarray on baseline PBMCs, and compare the gene sets for responders and non-responders (discriminant analysis). [ Time Frame: End of study ]
  4. To evaluate if treatment causes an altered ratio of Th17:Tregs in the circulation and skin, we will perform intracellular cytokine staining by flow cytometry on peripheral blood and from the shave biopsy. [ Time Frame: Before and after treatment ]

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00844363

United States, New York
Rockefeller University
New York, New York, United States, 10065
Sponsors and Collaborators
Rockefeller University
Doris Duke Charitable Foundation
Principal Investigator: Michelle Lowes, MD, PhD Rockefeller University

Responsible Party: Michelle Lowes, Rockefeller University Identifier: NCT00844363     History of Changes
Other Study ID Numbers: MLO-0651
First Posted: February 16, 2009    Key Record Dates
Last Update Posted: June 30, 2011
Last Verified: June 2011

Additional relevant MeSH terms:
Skin Diseases, Papulosquamous
Skin Diseases