Tunisian National Registry on Psoriasis
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
- 否
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)
