- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07448337
Psoriasis Comorbidities at Hospital Calderón Guardia
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.
Study Overview
Status
Detailed Description
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Daniel E Barquero-Orias, Dermatologist
- Phone Number: +506 83411026
- Email: debarque@ccss.sa.cr
Study Locations
-
-
Provincia de San José
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San José, Provincia de San José, Costa Rica, 40901
- Caja Costarricense del Seguro Social
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Contact:
- Daniel E Barquero-Orias, Dermatologist
- Phone Number: +506 83411026
- Email: debarque@ccss.sa.cr
-
Sub-Investigator:
- Daniel E Barquero-Orias, Dermatologist
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Sub-Investigator:
- Benjamin Hidalgo-Matlock, Dermatologist
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Principal Investigator:
- Pamela Cambronero-Ulate, Dermatology Resident
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
2024-2025
|
|
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.
|
2024-2025
|
|
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).
|
2024-2025
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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).
|
2024-2025
|
|
Psoriasis Severity
Time Frame: 2024-2025
|
Body Surface Area (BSA) Affected, percentage of body surface area affected by psoriasis
|
2024-2025
|
|
Association Between Psoriasis Severity and Comorbidities
Time Frame: 2024-2025
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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.
|
2024-2025
|
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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.
|
2024-2025
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CEC HCG 03-2026
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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