Narrowband UVB Phototherapy in the Treatment of Psoriasis Vulgaris - Full Text View

Sponsor:	Rockefeller University
Collaborator:	Doris Duke Charitable Foundation
Information provided by:	Rockefeller University
ClinicalTrials.gov Identifier:	NCT00844363

Purpose

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	Intervention
Chronic Plaque Psoriasis	Procedure: NB-UVB

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment
Official Title:	Mechanism of Action of Narrowband UVB Phototherapy in the Treatment of Psoriasis Vulgaris

Resource links provided by NLM:

MedlinePlus related topics: Psoriasis

U.S. FDA Resources

Further study details as provided by Rockefeller University:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]

Estimated Enrollment:	20
Study Start Date:	November 2008
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00844363

Contacts

Contact: Michelle Lowes, MD, PhD

212-327-7576

lowesm@rockefeller.edu

Locations

United States, New York
Rockefeller University	Recruiting
New York, New York, United States, 10065
Principal Investigator: Michelle Lowes, MD, PhD

Sponsors and Collaborators

Rockefeller University

Doris Duke Charitable Foundation

Investigators

Principal Investigator:

Michelle Lowes, MD, PhD

Rockefeller University

More Information

No publications provided

Responsible Party:	Rockefeller University ( Michelle Lowes )
Study ID Numbers:	MLO-0651
Study First Received:	February 12, 2009
Last Updated:	November 12, 2009
ClinicalTrials.gov Identifier:	NCT00844363 History of Changes
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Skin Diseases
Psoriasis
Skin Diseases, Papulosquamous

ClinicalTrials.gov processed this record on February 08, 2010