Narrowband UVB Phototherapy in the Treatment of Psoriasis Vulgaris

Chronic Plaque Psoriasis Clinical Trial

Official title:

Mechanism of Action of Narrowband UVB Phototherapy in the Treatment of Psoriasis Vulgaris

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00844363
• Other study ID #: MLO-0651
• Status: Terminated
• Phase: N/A
• First received: February 12, 2009
• Last updated: June 29, 2011
• Start date: November 2008
• Est. completion date: May 2011

Study information

• Verified date: June 2011
• Source: Rockefeller University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 20
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Plaque Psoriasis
• Psoriasis

Intervention

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.

Locations

Country	Name	City	State
United States	Rockefeller University	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Rockefeller University	Doris Duke Charitable Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcome is genomic analysis of lesional skin biopsies, in a time course experiment,by microarray and RT-PCR.		End of study	No
Secondary	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, ROR?).		End of study	No
Secondary	Effects of NB-UVB on NL skin will be determined by comparison of microarray analysis of NL skin biopsies throughout treatment.		End of study	No
Secondary	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).		End of study	No
Secondary	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.		Before and after treatment	No