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NCT Number: NCT07448428

Generalized Pustular Psoriasis Registry in Costa Rica

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.

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Key information

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

Daniel Barquero-Orias, Dermatologist

PRINCIPAL_INVESTIGATOR

Daniel E Barquero-Orias, Dermatologist

CONTACT

[email protected]

+506 83411026

Maria P Chavarria-Soto, Medical Doctor

SUB_INVESTIGATOR

About this study

Generalized pustular psoriasis (GPP) is a rare, severe, and potentially life-threatening inflammatory dermatosis characterized by recurrent flares of sterile pustules on erythematous skin with systemic involvement. In Costa Rica and much of Latin America, the absence of structured epidemiologic and clinical data has limited understanding of disease burden, phenotypic patterns, triggers, comorbidities, and real-world therapeutic outcomes. This has contributed to diagnostic delays, heterogeneous management, and uncertainty regarding optimal use of systemic and biologic therapies.

To address this gap, a national observational registry has been established within the Costa Rican Social Security health system to systematically collect standardized longitudinal data on patients with confirmed GPP. The registry captures information generated during routine dermatologic care without altering clinical management. Data are entered in a structured case report form aligned with international GPP research standards and include demographics, clinical phenotype, disease course, severity indices (e.g., GPPASI, PASI/BSA, DLQI), laboratory markers, comorbidities, identified triggers, and details of systemic and biologic treatments and their outcomes. Periodic follow-up enables evaluation of disease evolution, treatment persistence, dose modifications, adverse events, and complications over time.

The registry is designed to generate the first national dataset on GPP, enabling characterization of prevalence, regional distribution, severity patterns, and therapeutic responses in the local population. Standardized data collection is expected to improve comparability across centers, support development of evidence-based national management strategies, and facilitate participation in international collaborative research networks focused on rare and severe psoriasis.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. Disease course and evolution

    Time frame: 5 years

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

  2. Clinical severity of generalized pustular psoriasis

    Time frame: 5 years

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

  3. Change in Generalized Pustular Psoriasis Area and Severity Index

    Time frame: 5 years

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

  4. Change in Body Surface Area Affected

    Time frame: 5 years

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

  5. Treatment-Related Adverse Events

    Time frame: 5 years

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

  6. Proportion of Treatments Used

    Time frame: 5 years

    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.

Secondary outcomes

  1. Clinical severity of generalized pustular psoriasis

    Time frame: 5 years

    Assessed by the PASI (Psoriasis Area Severity Index) recorded during routine clinical evaluations.

  2. Change in Psoriasis Area and Severity Index

    Time frame: 5 years

    Change from baseline in Psoriasis Area and Severity Index score as a measure of cutaneous disease severity.

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

National Registry of Patients With Generalized Pustular Psoriasis Treated Within the Costa Rican Social Security System

Important dates

Study start
2026
Primary completion
2031
Study completion
2031
First posted
Mar 4, 2026
Registry last updated
Mar 9, 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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