Generalized Pustular Psoriasis Registry in Costa Rica

NCT07448428 | Not Yet Recruiting

• 1 other identifier: CEC HCG 14-2025
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational registry study is to characterize the clinical, epidemiological, and therapeutic features of patients with generalized pustular psoriasis (GPP) in Costa Rica through a standardized national registry. The main question it aims to answer is: What are the clinical, epidemiological, and therapeutic characteristics of patients with generalized pustular psoriasis registered in the country, and how do these relate to disease severity and evolution? Patients with GPP receiving routine dermatologic care in participating centers will have their demographic, clinical, severity, comorbidity, and treatment data recorded using a standardized case report form. Clinical assessments (e.g., GPPASI, PASI/BSA, DLQI), laboratory results, triggers, complications, and therapies will be documented and updated during periodic follow-up visits as part of usual care.

Conditions

Generalized Pustular Psoriasis; Generalized Pustular Psoriasis (GPP)

Keywords

Psoriasis; Registry; Costa Rica; Generalized pustular psoriasis

Outcome Measures

Primary Outcomes (6)

• Disease course and evolution

  Characterized by frequency of flares, presence of systemic complications, and need for hospitalization during follow-up, as recorded in standardized registry visits.

  5 years

• Clinical severity of generalized pustular psoriasis

  Assessed by the Generalized Pustular Psoriasis Area and Severity Index (GPPASI) recorded during routine clinical evaluations.

  5 years

• Change in Generalized Pustular Psoriasis Area and Severity Index

  Change from baseline in Generalized Pustular Psoriasis Area and Severity Index score as a measure of clinical severity over time.

  5 years

• Change in Body Surface Area Affected

  Change from baseline in percentage of Body Surface Area affected by psoriasis.

  5 years

• Treatment-Related Adverse Events

  Incidence of adverse events and serious adverse events considered related to systemic or biologic therapies.

  5 years

• Proportion of Treatments Used

  Proportion of patients receiving each category of therapy, including conventional systemic agents, biologic agents, and targeted therapies. Distribution of treatment types will be expressed as percentages of the total treated population.

  5 years

Secondary Outcomes (2)

• Clinical severity of generalized pustular psoriasis

  5 years

• Change in Psoriasis Area and Severity Index

  5 years

Eligibility Criteria

• Gender Eligibility Details: All
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population comprises patients of any age and sex with a confirmed diagnosis of generalized pustular psoriasis (GPP) receiving routine dermatologic care within participating centers of the Costa Rican Social Security (CCSS) health system. Eligible individuals are identified through the institutional electronic health record (EDUS) and enrolled in the national GPP registry during the study period. The population reflects real-world clinical practice across tertiary and regional referral hospitals, including both prevalent and incident GPP cases with varying disease duration, severity, comorbidity profiles, and exposure to conventional systemic and biologic therapies. Data are derived exclusively from standard clinical evaluations and follow-up visits conducted as part of usual care.

You may qualify if:

• Confirmed diagnosis of generalized pustular psoriasis (GPP) established by a board-certified dermatologist based on compatible clinical and/or histopathologic criteria.
• Registered diagnosis of GPP in the institutional electronic health record system (EDUS code L401) during the study period.
• Patients of any age and sex receiving care within participating centers of the Costa Rican Social Security system.
• Availability of clinical information sufficient for registry data entry and follow-up according to routine care.

You may not qualify if:

• Patients without a confirmed diagnosis of generalized pustular psoriasis (GPP) or with alternative pustular dermatoses (e.g., acute generalized exanthematous pustulosis) not meeting GPP diagnostic criteria.
• Absence of verifiable diagnosis in the institutional electronic health record (EDUS) or insufficient documentation to confirm GPP.
• Patients whose clinical records lack the minimum data required for registry variables or follow-up within routine care.

Sponsors & Collaborators

• Caja Costarricense de Seguro Social: lead

Study Sites (1)

Caja Costarricense del Seguro Social

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

Location

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Daniel E Barquero-Orias, Dermatologist

CONTACT

+506 83411026; debarque@ccss.sa.cr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 26, 2026
• First Posted: March 4, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): May 1, 2031
• Study Completion (Estimated): May 1, 2031
• Last Updated: March 9, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CO (1)