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临床试验/NCT05258838
NCT05258838已完成不适用

Tunisian National Registry on Psoriasis

Dacima Consulting1 个研究点 分布在 1 个国家目标入组 1,100 人开始时间: 2022年7月12日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
1,100
试验地点
1
主要终点
Psoriasis types

研究概览

简要总结

National cross-sectional multicentric study to describe the epidemiological characteristics of patients with Psoriasis in Tunisia

详细描述

PsoTReg is a Tunisian, descriptive, non-interventional, multicenter and cross-sectional clinical study performed in dermatology departments and outpatients clinics, of both public and private sectors. The study will enroll hospitalized and ambulatory patients with psoriasis disease, by successive inclusions until the end of the recruitment period, set at six months.

A Scientific Committee validates the scientific writing, a Steering Committee supervises the clinical operations of the project.

Collected data are managed by the DACIMA Clinical Suite®, the electronic data capture platform which complies with the FDA 21 CFR part 11 requirements (Food and Drug Administration 21 Code of Federal Regulations part 11), the HIPAA specifications (Health Insurance Portability and Accountability Act), and the ICH standards (International Conference on Harmonisation). A local authorization by the National Agency of Personal Data Protection will be obtained prior to study kick-off.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Cross Sectional

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients with psoriasis
  • Informed and written consent

排除标准

  • Any dermatology disease other than psoriasis

结局指标

主要结局

Psoriasis types

时间窗: At inclusion

Number of subjects with each type of psoriasis (Plaque psoriasis, Inverse psoriasis, Erythrodermic, Guttate psoriasis, Nail psoriasis, Pustular psoriasis, Psoriatic arthritis)

次要结局

  • Safety assessment of psoriasis medical treatment(At inclusion)
  • Demographic(At inclusion)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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