Psoriasis
Conditions
Keywords
Psoriasis, Dermatology, Tunisia, Dacima
Brief summary
National cross-sectional multicentric study to describe the epidemiological characteristics of patients with Psoriasis in Tunisia
Detailed description
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.
Interventions
None listed
Sponsors
Société Tunisienne de Dermatologie et de Vénéréologie
Dacima Consulting
Study design
Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Patients with psoriasis * Informed and written consent
Exclusion criteria
* Any dermatology disease other than psoriasis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Psoriasis types | At inclusion | Number of subjects with each type of psoriasis (Plaque psoriasis, Inverse psoriasis, Erythrodermic, Guttate psoriasis, Nail psoriasis, Pustular psoriasis, Psoriatic arthritis) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Demographic | At inclusion | Demographic data (gender frequency, age mean, body mass index mean) of subjects with psoriasis |
| Safety assessment of psoriasis medical treatment | At inclusion | Incidence of Treatment-Emergent Adverse Events \[Safety and Tolerability\]: Occurrence of infection or tuberculosis or death or any other treatment-related side effect of psoriasis medical treatment |
Countries
Tunisia
Outcome results
None listed