PsoriasisPsoTRegNCT05258838
Tunisian National Registry on Psoriasis
An observational study of Psoriasis, run by Dacima Consulting at 1 site in Tunisia.
Trial summary
National cross-sectional multicentric study to describe the epidemiological characteristics of patients with Psoriasis in Tunisia Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Psoriasis
- How many people
- 1,100 participants
- Where
- 1 siteTunisia
- Study dates
- 12 Jul 2022to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Hospitalized or outpatient subjects with psoriasis
Who may be able to join
- Patients with psoriasis
- Informed and written consent
Who cannot join
- Any dermatology disease other than psoriasis
Trial locations and contacts
1 site in 1 country.
Tunisia1 site
Société Tunisienne de Dermatologie et de Vénéréologie
Tunis, Tunisia
About this study
National cross-sectional multicentric study to describe the epidemiological characteristics of patients with Psoriasis in Tunisia
Read the 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
- Keywords
- Psoriasis, Dermatology, Tunisia, Dacima
- Medical subject headings
- Psoriasis
What is being measured
The primary outcome is the main question the study is designed to answer.
Psoriasis types
Number of subjects with each type of psoriasis (Plaque psoriasis, Inverse psoriasis, Erythrodermic, Guttate psoriasis, Nail psoriasis, Pustular psoriasis, Psoriatic arthritis)
Measured: At inclusion
Secondary outcomes (2)
Demographic
Demographic data (gender frequency, age mean, body mass index mean) of subjects with psoriasis
Measured: At inclusion
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
Measured: At inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2022
- Study start12 Jul 2022
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 1,100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dacima Consulting
- Sponsor type
- University, hospital or other
- Collaborators
- Société Tunisienne de Dermatologie et de Vénéréologie
- Responsible party
- Sponsor
- Investigators
- Houda Hammami, MD, Study chair, University Hospital of Habib Thameur, Ben Arous, TunisiaMohamed Denguezli, MD, Study chair, University Hospital of Farhat Hached, Sousse, TunisiaAsmahen Souissi, MD, Study director, dr.asmahanesouissi@gmail.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05258838
- Sponsor's protocol ID
- DAC-010-PSOTREG
- Acronym
- PsoTReg
- Status last verified
- Feb 2025
- First submitted
- 14 Feb 2022
- Last updated
- 17 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Litaiem N, Akid M, Boudaya S, Zaouak A, Souissi A, Doss N, Gara S, Jaber K, Aounallah A, Zahaf A, Turki H, Mokni M, Zeglaoui F, Dhaoui MA, Razgallah R, Denguezli M, Hammami H. Severity of Psoriasis in Tunisia: Cross-Sectional Results From the National PsoTReg Registry. Int J Dermatol. 2026 Jul 14. doi: 10.1111/ijd.70589. Online ahead of print.
PubMed 42452943
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tunisian National Registry on Psoriasis
- ClinicalTrials.gov ID
- NCT05258838
- Acronym / sponsor ID
- PsoTReg / DAC-010-PSOTREG
- Conditions
- Psoriasis
- Keywords
- Psoriasis, Dermatology, Tunisia, Dacima
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,100 participants (actual)
- Lead sponsor
- Dacima ConsultingUniversity, hospital or other
- Collaborators
- Société Tunisienne de Dermatologie et de Vénéréologie
- Study start
- 12 Jul 2022 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 28 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Hospitalized or outpatient subjects with psoriasis
Key inclusion criteria (2 listed)
- Patients with psoriasis
- Informed and written consent
Key exclusion criteria (1 listed)
- Any dermatology disease other than psoriasis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
2 secondary outcomes
Demographic
Time frame: At inclusion
Safety assessment of psoriasis medical treatment
Time frame: At inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2025.
- Derived from this study: PubMed 42452943Litaiem N, Akid M, Boudaya S, Zaouak A, Souissi A, Doss N, Gara S, Jaber K, Aounallah A, Zahaf A, Turki H, Mokni M, Zeglaoui F, Dhaoui MA, Razgallah R, Denguezli M, Hammami H. Severity of Psoriasis in Tunisia: Cross-Sectional Results From the National PsoTReg Registry. Int J Dermatol. 2026 Jul 14. doi: 10.1111/ijd.70589. Online ahead of print.
- Facebook page of "Société Tunisienne de Dermatologie et de Vénéréologie"Link provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Psoriasis
Not yet recruitingPhase 2
Extension Study of Safety and Tolerability of DDY391 in Participants With Moderate to Severe Psoriatic Arthritis (CDDY391A12201-extension)
Moderate to Severe Psoriatic Arthritis
Recruiting
Efficacy of a Self-Management Smartphone App to Improve Safety Skills in Patients With Inflammatory Arthritis
Rhumatoid Arthisis, Spondyloarthritis (SA)
Active, not recruitingPhase 2
Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis
Plaque Psoriasis
RecruitingPhase 1
A Study of HB0017 Injection in Healthy Volunteers to Evaluate Safety and Tolerability of a Single Subcutaneous Injection in Low-Body-Weight Subjects; and Pharmacokinetics at Different Subcutaneous Injection Sites at the Same Dose
Psoriasis, Ankylosing Spondylitis
RecruitingPhase 1
A Study to Learn if Bimekizumab Given in Different Ways is Safe and Moves Similarly Throughout the Body Over Time in Adults
Psoriatic Arthritis, Axial Spondyloarthritis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Houda Hammami, MD study chair
University Hospital of Habib Thameur, Ben Arous, Tunisia
Mohamed Denguezli, MD study chair
University Hospital of Farhat Hached, Sousse, Tunisia
Asmahen Souissi, MD study director
dr.asmahanesouissi@gmail.com
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psoriasis, run by Dacima Consulting at 1 site in Tunisia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tunisia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Psoriasis types (time frame: At inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05258838, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2025.