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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05258838
Other study ID # DAC-010-PSOTREG
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date July 12, 2022
Est. completion date July 1, 2024

Study information

Verified date June 2024
Source Dacima Consulting
Contact Houda Hammami, MD
Phone +21698966255
Email hammamighorbel@yahoo.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

National cross-sectional multicentric study to describe the epidemiological characteristics of patients with Psoriasis in Tunisia


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 SuiteĀ®, 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 1200
Est. completion date July 1, 2024
Est. primary completion date July 1, 2024
Accepts healthy volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Patients with psoriasis - Informed and written consent Exclusion Criteria: - Any dermatology disease other than psoriasis

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Tunisia Société Tunisienne de Dermatologie et de Vénéréologie Tunis

Sponsors (2)

Lead Sponsor Collaborator
Dacima Consulting Société Tunisienne de Dermatologie et de Vénéréologie

Country where clinical trial is conducted

Tunisia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Psoriasis types Number of subjects with each type of psoriasis (Plaque psoriasis, Inverse psoriasis, Erythrodermic, Guttate psoriasis, Nail psoriasis, Pustular psoriasis, Psoriatic arthritis) At inclusion
Secondary Demographic Demographic data (gender frequency, age mean, body mass index mean) of subjects with psoriasis At inclusion
Secondary Safety assessment of psoriasis medical treatment 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 At inclusion
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