NCT05258838

Tunisian National Registry on Psoriasis

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,100 (actual)
• Sponsor: Dacima Consulting · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Psoriasis

Timeline

• Start date: 2022-07-12
• Primary completion: 2024-12-31
• Completion: 2024-12-31
• First posted: 2022-02-28
• Last updated: 2025-02-17

Locations

1 site across 1 country: Tunisia