Clinical trial NCT00844363: Narrowband UVB Phototherapy in the Treatment of Psoriasis Vulgaris
Official title: Mechanism of Action of Narrowband UVB Phototherapy in the Treatment of Psoriasis Vulgaris
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Chronic Plaque Psoriasis
Lead sponsor: Rockefeller University
Sponsor class: OTHER
Collaborators: name: Doris Duke Charitable Foundation
First posted: 2009-02-16
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: The primary outcome is genomic analysis of lesional skin biopsies, in a time course experiment,by microarray and RT-PCR.
timeFrame: End of study
Secondary outcomes:
measure: 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).
timeFrame: End of study
measure: Effects of NB-UVB on NL skin will be determined by comparison of microarray analysis of NL skin biopsies throughout treatment.
timeFrame: End of study
measure: 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).
timeFrame: End of study
measure: 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.
timeFrame: Before and after treatment
Other outcomes:
Locations:
city: New York
country: United States
facility: Rockefeller University
state: New York
Study officials:
affiliation: Rockefeller University
name: Michelle Lowes, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: