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临床试验/NCT02162472
NCT02162472已完成不适用

Videocapillaroscopy Assessment During Systemic Agent Therapy in Patients With Psoriasis

Northwestern University1 个研究点 分布在 1 个国家目标入组 19 人开始时间: 2015年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
19
试验地点
1
主要终点
Videocapillaroscopy assessment in psoriasis

研究概览

简要总结

The aim of this study is to determine if videocapillaroscopy could be used as an objective and reliable method to assess psoriasis severity and to document improvement during treatment by measuring changes in vascular features.

详细描述

This is a single-center, prospective, observational study that will recruit subjects from Northwestern University to examine the degree of improvement of psoriatic plaques during systemic therapy treatment. Thirty patients with a confirmed diagnosis of "active" psoriasis treated with a single systemic agent will be recruited from the Northwestern Medical Faculty Foundation Dermatology clinic. The study population will include 15 patients receiving adalimumab and 15 patients receiving methotrexate.

Eight visits will be completed for each subject: visit 0 (baseline) and visits 1-8 (week 2, 4, 6, 8, 12, 16 and 24). At the baseline visit, after informed consent is obtained, a capillaroscopic examination will be performed to assess for evidence of characteristic vascular alterations. If such changes are present, the remainder of the baseline visit will be completed. This includes gathering personal information (age, race, gender etc.), clinical history (time of first diagnosis, presentation site, treatment used, biopsy results if previously performed, etc.) and past medical history (including current and previous medications). At each of the subsequent visits (visit 1-8), any changes to medical history and/or medications will be obtained and recorded. At each of the eight visits, a dermatologic physical examination, including PASI and PGA scores will be performed.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Subjects with a clinical diagnosis of chronic active plaque psoriasis
  • Subjects eligible for systemic monotherapy (oral or biologic agents).
  • Subjects with evidence of characteristic vascular alterations on capillaroscopic examination.
  • Subjects who are able to complete the study visits and procedures, including completion of the DLQI questionnaire.
  • Subjects who are willing to have standardized digital photographs taken of 2 different target plaque lesions on the extremities.
  • Subjects who are willing to have videocapillaroscopic photographs taken of 2 different target plaque lesions as well as of 2 areas of uninvolved skin on the extremities.
  • Subjects who have had a "4 week" washout period if they have recently changed systemic psoriatic therapy.

排除标准

  • Those who do not fit the inclusion criteria.
  • Subjects who are unable to understand the protocol or give informed consent.

结局指标

主要结局

Videocapillaroscopy assessment in psoriasis

时间窗: Week 0, 2, 4, 6, 8, 12, 16 and 24

The primary objective is to determine if videocapillaroscopy could be used as an objective and reliable method to assess psoriasis severity and to document improvement during treatment by measuring changes in vascular features.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Joaquin Brieva

Associate Professor

Northwestern University

研究点 (1)

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