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NCT Number: NCT07448337

Psoriasis Comorbidities at Hospital Calderón Guardia

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.

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Key information

Age range

12 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Caja Costarricense del Seguro Social

San José, Provincia de San José, 40901, Costa Rica

Location contact

Benjamin Hidalgo-Matlock, Dermatologist

SUB_INVESTIGATOR

Daniel E Barquero-Orias, Dermatologist

CONTACT

[email protected]

+506 83411026

Daniel E Barquero-Orias, Dermatologist

SUB_INVESTIGATOR

Pamela Cambronero-Ulate, Dermatology Resident

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

  3. 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).

Secondary outcomes

  1. Psoriasis Severity

    Time frame: 2024-2025

    Psoriasis Area and Severity Index (PASI), continuous score (0-72), categorized as mild (<10), moderate (10-20), or severe (>20).

  2. Psoriasis Severity

    Time frame: 2024-2025

    Body Surface Area (BSA) Affected, percentage of body surface area affected by psoriasis

  3. Association Between Psoriasis Severity and Comorbidities

    Time frame: 2024-2025

    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.

  4. Inflammatory and Metabolic Biomarkers

    Time frame: 2024-2025

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Daniel E Barquero-Orias, Dermatologist

CONTACT

[email protected]

+506 83411026

Sponsors and collaborators

Lead sponsor

Caja Costarricense de Seguro Social

Other Gov

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 4, 2026
Registry last updated
Apr 8, 2026

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.

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