Back to resultsNarrowband UVB Phototherapy in the Treatment of Psoriasis Vulgaris
Primary Purpose
Chronic Plaque Psoriasis
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
NB-UVB
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Plaque 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.
Sites / Locations
- Rockefeller University
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
NB-UVB
Arm Description
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.
Outcomes
Primary Outcome Measures
The primary outcome is genomic analysis of lesional skin biopsies, in a time course experiment,by microarray and RT-PCR.
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).
Effects of NB-UVB on NL skin will be determined by comparison of microarray analysis of NL skin biopsies throughout treatment.
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).
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.
Full Information
NCT ID
NCT00844363
First Posted
February 12, 2009
Last Updated
June 29, 2011
Sponsor
Rockefeller University
Collaborators
Doris Duke Charitable Foundation
1. Study Identification
Unique Protocol Identification Number
NCT00844363
Brief Title
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
2. Study Status
Record Verification Date
June 2011
Overall Recruitment Status
Terminated
Why Stopped
Unable to isolate sufficient cells from the skin biopsy to perform study related experiments
Study Start Date
November 2008 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
May 2011 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Rockefeller University
Collaborators
Doris Duke Charitable Foundation
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Plaque Psoriasis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
NB-UVB
Arm Type
Other
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
NB-UVB
Other Intervention Name(s)
narrowband UVB phototherapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
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
Title
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
Title
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
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michelle Lowes, MD, PhD
Organizational Affiliation
Rockefeller University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rockefeller University
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Narrowband UVB Phototherapy in the Treatment of Psoriasis Vulgaris
We'll reach out to this number within 24 hrs