Narrowband UVB Phototherapy in the Treatment of Psoriasis Vulgaris
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.
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Mechanism of Action of Narrowband UVB Phototherapy in the Treatment of Psoriasis Vulgaris|
- 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 ]
- 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 ]
|Study Start Date:||November 2008|
|Study Completion Date:||May 2011|
|Primary Completion Date:||May 2011 (Final data collection date for primary outcome measure)|
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.
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00844363
|United States, New York|
|New York, New York, United States, 10065|
|Principal Investigator:||Michelle Lowes, MD, PhD||Rockefeller University|