Tunisian National Registry on Psoriasis

Completed

• Conditions: Psoriasis

• Registration Number: NCT05258838
• Lead Sponsor: Dacima Consulting

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.

Study Timeline

• Study First Submitted: 2022-02-14
• Study First Submitted QC: 2022-02-17
• Study First Posted: 2022-02-28
• Study Start: 2022-07-12
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-13
• Last Update Posted: 2025-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1100

Inclusion Criteria

• Patients with psoriasis
• Informed and written consent

Exclusion Criteria

• Any dermatology disease other than psoriasis

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
Demographic	At inclusion	Demographic data (gender frequency, age mean, body mass index mean) of subjects with psoriasis

Trial Locations

Locations (1)

Société Tunisienne de Dermatologie et de Vénéréologie; 🇹🇳 Tunis, Tunisia