Tunisian National Registry on Psoriasis | Clinical Trial

Key information

Conditions

Psoriasis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Société Tunisienne de Dermatologie et de Vénéréologie

Tunis, Tunisia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients with psoriasis
Informed and written consent

Exclusion criteria

Any dermatology disease other than psoriasis

Treatment and study plan

Primary outcomes

Psoriasis types

Time frame: At inclusion

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

Secondary outcomes

Demographic

Time frame: At inclusion

Demographic data (gender frequency, age mean, body mass index mean) of subjects with psoriasis
Safety assessment of psoriasis medical treatment

Time frame: 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

Sponsors and collaborators

Lead sponsor

Dacima Consulting

Other

Collaborators

Société Tunisienne de Dermatologie et de Vénéréologie

Registry information

Acronym: PsoTReg

Important dates

Study start: 2022
Primary completion: 2024
Study completion: 2024
First posted: Feb 28, 2022
Registry last updated: Feb 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed