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TerminatedNCT00844363Updated Jun 30, 2011

Narrowband UVB Phototherapy in the Treatment of Psoriasis Vulgaris

An interventional study of NB-UVB in Chronic Plaque Psoriasis, sponsored by Rockefeller University. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-06-30.

Sponsored by Rockefeller University · Not applicable, Interventional, and Treatment

Why this study was terminated
Unable to isolate sufficient cells from the skin biopsy to perform study related experiments
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
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Study 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.

02

Conditions studied

  • Chronic Plaque Psoriasis

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03

In context

Psoriasis

1,899 studies on the registry are indexed under Psoriasis; 233 are open to participants now.

This study's planned enrollment of 20 is below the median of 70 across 1,447 interventional studies indexed under Psoriasis.

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Lead sponsor

Rockefeller University is the lead sponsor of 120 studies on the registry; 3 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 6 (43%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Other
    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.

    Procedure: NB-UVB

Interventions

  • ProcedureNB-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.

    Also known as: narrowband UVB phototherapy

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What researchers measure

Primary outcomes

  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 outcomes

  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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Study locations

1 site
  • Rockefeller University
    New York, New York 10065, United States
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 30, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00844363
Lead sponsor
Rockefeller University
Collaborators
Doris Duke Charitable Foundation
First posted
Feb 16, 2009
Start date
Nov 2008
Primary completion
May 2011
Completion
May 2011
Last update
Jun 30, 2011

Study contacts

Michelle Lowes, MD, PhD
principal investigator · Rockefeller University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Jun 2011. You cannot join it, but the record below documents what was studied.

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