NCT00844363终止不适用
Mechanism of Action of Narrowband UVB Phototherapy in the Treatment of Psoriasis Vulgaris
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- The primary outcome is genomic analysis of lesional skin biopsies, in a time course experiment,by microarray and RT-PCR.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
The primary outcome is genomic analysis of lesional skin biopsies, in a time course experiment,by microarray and RT-PCR.
时间窗: End of study
次要结局
- Effects of NB-UVB on NL skin will be determined by comparison of microarray analysis of NL skin biopsies throughout treatment.(End of study)
- 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).(End of study)
- 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)
- 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)
研究者
研究点 (1)
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