Effects of UVB Excimer Laser on Serum Inflammatory Markers in Patients With Psoriasis
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Change in serum inflammatory markers
研究概览
简要总结
The overall aims for this study are to determine whether UVB excimer laser treatment of psoriasis affects serum inflammatory markers, and to assess hyperpigmentation and erythema with excimer laser treatment.
The investigators hypothesize that treatment of psoriasis with UVB delivered via 308 nm excimer laser will decrease the levels of serum inflammatory markers. The investigators hypothesize that treatment will decrease plaque erythema and will result in minimal hyperpigmentation.
详细描述
Subjects will undergo Excimer treatment twice a week until they reach a PASI 75 improvement, or until they reach the maximum of 20 total treatments. A blood draw to assess serum inflammatory markers will be performed at the screening visit and final visit. Chromameter assessment, photographs, PASI and PGA (Physician Global Assessment) will be performed throughout the study to monitor psoriasis improvement, hyperpigmentation and erythema.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •Age 18 years and older
- •Male or female with diagnosis of psoriasis
- •Psoriasis involvement of 5-15% BSA
- •Has been off systemic psoriasis therapies (e.g. retinoids, methotrexate, biologic agents, etc) for at least 4 weeks
- •Has been off topical therapies (e.g. calcipotriene, topical steroids) for at least 2 weeks
- •Fitzpatrick Skin Types I-VI
排除标准
- •Active history of photosensitivity (e.g. xeroderma pigmentosum, lupus erythematosus, porphyria, severe polymorphous light eruption, solar urticaria)
- •Any suspicion that the psoriasis is of the photosensitive variant.
- •Any medical condition that could be aggravated or may cause extreme discomfort during the study period.
结局指标
主要结局
Change in serum inflammatory markers
时间窗: 23 visits (~12 weeks)
Change in CRP, MPO, S100 and Resistin levels from screening to final visit.
次要结局
- Improvement in Psoriasis based on PASI assessment(23 visits (~12 weeks))
- Objective measure of erythema(23 visits (~12 weeks))
- Objective measure of hyperpigmentation(23 visits (~12 weeks))
- Improvement in psoriasis based on PGA(23 visits (~12 weeks))
研究者
Margaret Bobonich, NP
Principal Investigator
University Hospitals Cleveland Medical Center