Study on the Therapeutic Mechanisms of Dithranol Treatment With Regard to Pro- and Contra-inflammatory Factors, microRNA as Well as Lymph and Blood Vessels in Patients With Chronic Plaque Psoriasis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Protein and mRNA expression of pro- and contra-inflammatory factors in the skin and blood
研究概览
简要总结
Dithranol (known in the U.S.A. as anthralin and in Germany as cignolin) is one of the oldest and safest topical anti-psoriatic treatments. However, despite explorative investigations, the skin disease-clearing mechanisms of dithranol remain poorly understood (Painsi et al, JDDG 2015). The purpose of this study is to investigate the therapeutic mechanisms of dithranol in psoriasis.
详细描述
Skins biopsies from psoriatic skin and blood samples will be taken before (day 0) and at several time points after start (day 4, week 2-3, and week 6-7) of dithranol therapy to be subjected to an explorative analysis (see outcome measures). A total of maximal 15 psoriasis patients will be enrolled. Normal lesion-adjacent skin from 10 patients undergoing surgery for non-inflammatory conditions will serve as control.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males and females over 18 years of age
- •Clinical diagnosis of chronic plaque psoriasis
- •Dithranol treatment scheduled
排除标准
- •Systemic anti-psoriatic therapy (DMARD, phototherapy and/or Biologics) within 4 weeks of study entry (start of dithranol treatment)
- •Topical treatment with steroids and or vitamin D3 analogues within 2 weeks of study entry (start of dithranol treatment)
- •Autoimmune disorders
- •Poor general health status
- •Intolerance of dithranol
- •Pregnancy and lactation period
研究组 & 干预措施
Psoriasis
Psoriasis patients treated with dithranol
干预措施: Psoriasis
Non-Psoriasis
Non-Psoriasis patients undergoing surgery for skin lesions. Tumor-adjacent skin is collected for control purposes.
干预措施: Non-Psoriasis
结局指标
主要结局
Protein and mRNA expression of pro- and contra-inflammatory factors in the skin and blood
时间窗: day 0, 4, 14, 42
次要结局
- Size and density of lymph and blood vessels in the skin(day 0, 4, 14, 42)
- Angiogenic factors and their receptors in the skin(day 0, 4, 14, 42)
- MicroRNA expression in skin and blood(day 0, 4, 14, 42)
- Inflammatory infiltrate in the skin and alterations of the epidermis(day 0, 4, 14, 42)
- Microarray analysis of skin samples and subsequent targeted analysis of deregulated genes(day 0, 4, 14, 42)
研究者
Peter Wolf, MD
Univ.Prof. Dr. Peter Wolf
Medical University of Graz