Tunisian National Registry on Psoriasis

NCT ID: NCT05258838

Last Updated: 2025-02-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-07-12

Study Completion Date

2024-12-31

Brief Summary

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

Detailed Description

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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

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Psoriasis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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Inclusion Criteria

* Patients with psoriasis
* Informed and written consent

Exclusion Criteria

* Any dermatology disease other than psoriasis
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Société Tunisienne de Dermatologie et de Vénéréologie

UNKNOWN

Sponsor Role collaborator

Dacima Consulting

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Houda Hammami, MD

Role: STUDY_CHAIR

University Hospital of Habib Thameur, Ben Arous, Tunisia

Mohamed Denguezli, MD

Role: STUDY_CHAIR

University Hospital of Farhat Hached, Sousse, Tunisia

Asmahen Souissi, MD

Role: STUDY_DIRECTOR

[email protected]

Locations

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Société Tunisienne de Dermatologie et de Vénéréologie

Tunis, Tunisia, Tunisia

Site Status

Countries

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Tunisia

Related Links

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https://www.facebook.com/stdv.tn/?locale=fr_FR

Facebook page of "Société Tunisienne de Dermatologie et de Vénéréologie"

Other Identifiers

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DAC-010-PSOTREG

Identifier Type: -

Identifier Source: org_study_id

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