PsoriasisNCT07448337
Psoriasis Comorbidities at Hospital Calderón Guardia
An observational study of Psoriasis and Psoriasis Arthritis, run by Caja Costarricense de Seguro Social at 1 site in Costa Rica.
Trial summary
The goal of this observational study is to characterize the epidemiologic, clinical, severity, and therapeutic features of patients with psoriasis treated in Costa Rica between 2024 and 2025. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Psoriasis, Psoriasis Arthritis, Psoriasis (PsO)
- How many people
- 350 participants
- Where
- 1 siteCosta Rica
- Study dates
- May 2026to May 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study population comprises adolescents and adults (≥12 years) with a confirmed diagnosis of psoriasis documented in the Electronic Health Record (EHR-EDUS) of Hospital Calderón Guardia who were evaluated in outpatient dermatology or rheumatology clinics between 2024 and 2025. Eligible patients received systemic therapy and/or phototherapy for psoriasis and had sufficient clinical information to assess disease severity, metabolic comorbidities, atherosclerotic cardiovascular disease, and psoriatic arthritis. This hospital-based cohort reflects real-world patients with moderate-to-severe psoriasis managed in specialized care within the Costa Rican public health system during the study period.
Who may be able to join
- Patients evaluated in outpatient clinics during the period 2024-2025.
- Patients receiving systemic therapy and/or phototherapy.
- Patients aged 12 years or older, of any sex.
- Availability of sufficient clinical information to assess psoriasis severity, metabolic comorbidities, atherosclerotic cardiovascular disease, and psoriatic arthritis.
- At least one dermatologic or rheumatologic evaluation recorded in the Electronic Health Record (EHR-EDUS) during the study period.
- Confirmed diagnosis of psoriasis documented in the Electronic Health Record (EHR-EDUS) of Hospital Calderón Guardia.
Who cannot join
- Clinical records insufficient to evaluate psoriasis severity, comorbidities, or therapeutic profile.
- Patients managed exclusively with topical therapies.
- Duplicate or inconsistent records, preventing accurate patient classification.
- Cutaneous conditions not compatible with psoriasis.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Costa Rica1 site
Caja Costarricense del Seguro Social
San José, Provincia de San José, 40901
Daniel E Barquero-Orias, Dermatologist, +506 83411026, debarque@ccss.sa.cr
Daniel E Barquero-Orias, Dermatologist
About this study
Official title: Prevalence of Metabolic Comorbidities, Atherosclerotic Arterial Disease, and Psoriatic Arthritis in Patients With Psoriasis and Their Association With Clinical Severity and Therapeutic Profile Among Patients Treated at Hospital Rafael Ángel Calderón Guardia During 2024-2025
The goal of this observational study is to characterize the epidemiologic, clinical, severity, and therapeutic features of patients with psoriasis treated in Costa Rica between 2024 and 2025. The main questions it aims to answer are:
What are the demographic and clinical characteristics and severity profiles of psoriasis patients?
What treatments are used in routine clinical practice, and how are they associated with disease severity and outcomes?
Patients with psoriasis receiving dermatologic care during the study period will be included. Data will be obtained retrospectively from electronic medical records and clinical registries without intervention or modification of treatment.
Read the detailed description
Psoriasis is a chronic immune-mediated inflammatory dermatosis with variable severity, systemic associations, and substantial quality-of-life impact. Although multiple topical, phototherapy, systemic, and biologic treatments are available, real-world epidemiologic and therapeutic data in Costa Rica remain limited. This study is a retrospective observational characterization of psoriasis patients treated between 2024 and 2025. Unlike interventional trials evaluating specific drugs or prospective registries of targeted therapies, this study analyzes existing clinical records to describe demographic distribution, clinical subtypes, severity (PASI/BSA/DLQI), comorbidities, and treatment patterns across routine care. It does not introduce therapeutic modifications or standardized follow-up, but reflects real-world management decisions across disease severities. By capturing population-level data on psoriasis presentation and treatment in Costa Rica, the study provides baseline national evidence distinct from drug-specific or interventional psoriasis studies.
- Conditions
- Psoriasis, Psoriasis Arthritis, Psoriasis (PsO), Psoriasis Patients
- Keywords
- Comorbidities, Costa Rica, Psoriasis, Real-world data, Disease severity, Epidemiology
- Medical subject headings
- Psoriasis
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of Metabolic Comorbidities in Patients With Psoriasis
Proportion (%) of patients with documented diagnosis of obesity (BMI ≥30 kg/m²), diabetes mellitus (prior diagnosis or HbA1c ≥6.5%), hypertension (prior diagnosis or BP ≥140/90 mmHg), dyslipidemia (prior diagnosis or abnormal lipid profile), and metabolic syndrome.
Measured: 2024-2025
Prevalence of Atherosclerotic Cardiovascular Disease
Proportion (%) of patients with documented history of coronary artery disease, myocardial infarction, angina/revascularization, ischemic stroke, or peripheral arterial disease.
Measured: 2024-2025
Prevalence of Psoriatic Arthritis
Proportion (%) of patients with rheumatologist-confirmed diagnosis of psoriatic arthritis, including characterization of predominant clinical domain (peripheral arthritis, axial involvement, enthesitis, dactylitis).
Measured: 2024-2025
Secondary outcomes (4)
Psoriasis Severity
Psoriasis Area and Severity Index (PASI), continuous score (0-72), categorized as mild (<10), moderate (10-20), or severe (>20).
Measured: 2024-2025
Psoriasis Severity
Body Surface Area (BSA) Affected, percentage of body surface area affected by psoriasis
Measured: 2024-2025
Association Between Psoriasis Severity and Comorbidities
Statistical association between severity categories and presence of metabolic comorbidities, atherosclerotic disease, and psoriatic arthritis using chi-square, Fisher's exact test, t-test or Mann-Whitney U test.
Measured: 2024-2025
Inflammatory and Metabolic Biomarkers
Continuous values of C-reactive protein, erythrocyte sedimentation rate, neutrophil-to-lymphocyte ratio, platelet-to-lymphocyte ratio, monocyte-to-lymphocyte ratio, cardiac troponin, B-type natriuretic peptide, total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, triglycerides, fasting plasma glucose, glycated hemoglobin, serum creatinine, estimated glomerular filtration rate, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, and total bilirubin.
Measured: 2024-2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2026
- Study startMay 2026 (estimated)
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Caja Costarricense de Seguro Social
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Daniel Barquero Orias, Caja Costarricense de Seguro Social
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07448337
- Sponsor's protocol ID
- CEC HCG 03-2026
- Status last verified
- Apr 2026
- First submitted
- 26 Feb 2026
- Last updated
- 8 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: According to the protocol.
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Metabolic Comorbidities, Atherosclerotic Arterial Disease, and Psoriatic Arthritis in Patients With Psoriasis and Their Association With Clinical Severity and Therapeutic Profile Among Patients Treated at Hospital Rafael Ángel Calderón Guardia During 2024-2025
- ClinicalTrials.gov ID
- NCT07448337
- Acronym / sponsor ID
- CEC HCG 03-2026
- Conditions
- Psoriasis, Psoriasis Arthritis, Psoriasis (PsO), Psoriasis Patients
- Keywords
- Comorbidities, Costa Rica, Psoriasis, Real-world data, Disease severity, Epidemiology
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Caja Costarricense de Seguro SocialOther government
- Study start
- May 2026 (estimated)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 4 Mar 2026 (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.
The goal of this observational study is to characterize the epidemiologic, clinical, severity, and therapeutic features of patients with psoriasis treated in Costa Rica between 2024 and 2025. The main questions it aims to answer are:
What are the demographic and clinical characteristics and severity profiles of psoriasis patients?
What treatments are used in routine clinical practice, and how are they associated with disease severity and outcomes?
Patients with psoriasis receiving dermatologic care during the study period will be included. Data will be obtained retrospectively from electronic medical records and clinical registries without intervention or modification of treatment.
Detailed description
Psoriasis is a chronic immune-mediated inflammatory dermatosis with variable severity, systemic associations, and substantial quality-of-life impact. Although multiple topical, phototherapy, systemic, and biologic treatments are available, real-world epidemiologic and therapeutic data in Costa Rica remain limited. This study is a retrospective observational characterization of psoriasis patients treated between 2024 and 2025. Unlike interventional trials evaluating specific drugs or prospective registries of targeted therapies, this study analyzes existing clinical records to describe demographic distribution, clinical subtypes, severity (PASI/BSA/DLQI), comorbidities, and treatment patterns across routine care. It does not introduce therapeutic modifications or standardized follow-up, but reflects real-world management decisions across disease severities. By capturing population-level data on psoriasis presentation and treatment in Costa Rica, the study provides baseline national evidence distinct from drug-specific or interventional psoriasis studies.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population comprises adolescents and adults (≥12 years) with a confirmed diagnosis of psoriasis documented in the Electronic Health Record (EHR-EDUS) of Hospital Calderón Guardia who were evaluated in outpatient dermatology or rheumatology clinics between 2024 and 2025. Eligible patients received systemic therapy and/or phototherapy for psoriasis and had sufficient clinical information to assess disease severity, metabolic comorbidities, atherosclerotic cardiovascular disease, and psoriatic arthritis. This hospital-based cohort reflects real-world patients with moderate-to-severe psoriasis managed in specialized care within the Costa Rican public health system during the study period.
Key inclusion criteria (6 listed)
- Patients evaluated in outpatient clinics during the period 2024-2025.
- Patients receiving systemic therapy and/or phototherapy.
- Patients aged 12 years or older, of any sex.
- Availability of sufficient clinical information to assess psoriasis severity, metabolic comorbidities, atherosclerotic cardiovascular disease, and psoriatic arthritis.
- At least one dermatologic or rheumatologic evaluation recorded in the Electronic Health Record (EHR-EDUS) during the study period.
Key exclusion criteria (4 listed)
- Clinical records insufficient to evaluate psoriasis severity, comorbidities, or therapeutic profile.
- Patients managed exclusively with topical therapies.
- Duplicate or inconsistent records, preventing accurate patient classification.
- Cutaneous conditions not compatible with 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
Prevalence of Metabolic Comorbidities in Patients With Psoriasis
Time frame: 2024-2025
Proportion (%) of patients with documented diagnosis of obesity (BMI ≥30 kg/m²), diabetes mellitus (prior diagnosis or HbA1c ≥6.5%), hypertension (prior diagnosis or BP ≥140/90 mmHg), dyslipidemia (prior diagnosis or abnormal lipid profile), and metabolic syndrome.
Prevalence of Atherosclerotic Cardiovascular Disease
Time frame: 2024-2025
Proportion (%) of patients with documented history of coronary artery disease, myocardial infarction, angina/revascularization, ischemic stroke, or peripheral arterial disease.
Prevalence of Psoriatic Arthritis
Time frame: 2024-2025
Proportion (%) of patients with rheumatologist-confirmed diagnosis of psoriatic arthritis, including characterization of predominant clinical domain (peripheral arthritis, axial involvement, enthesitis, dactylitis).
4 secondary outcomes
Psoriasis Severity
Time frame: 2024-2025
Psoriasis Severity
Time frame: 2024-2025
Association Between Psoriasis Severity and Comorbidities
Time frame: 2024-2025
Inflammatory and Metabolic Biomarkers
Time frame: 2024-2025
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2026.
- Individual participant dataSharing planned: No. According to the protocol.
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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.
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 and Psoriasis Arthritis, run by Caja Costarricense de Seguro Social at 1 site in Costa Rica.
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 6 inclusion and 4 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: opening soon, as of the sponsor's last update on 8 Apr 2026. 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 Costa Rica. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Daniel E Barquero-Orias, Dermatologist (+506 83411026, debarque@ccss.sa.cr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of Metabolic Comorbidities in Patients With Psoriasis (time frame: 2024-2025). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Apr 2026.