Generalized Pustular PsoriasisNCT07448428
Generalized Pustular Psoriasis Registry in Costa Rica
An observational study of Generalized Pustular Psoriasis and Generalized Pustular Psoriasis (GPP), run by Caja Costarricense de Seguro Social at 1 site in Costa Rica.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Generalized Pustular Psoriasis, Generalized Pustular Psoriasis (GPP)
- How many people
- 50 participants
- Where
- 1 siteCosta Rica
- Study dates
- May 2026to May 2031
- How long will I take part?
- 5 Years
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
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 Barquero-Orias, Dermatologist
About this study
Official title: National Registry of Patients With Generalized Pustular Psoriasis Treated Within the Costa Rican Social Security System
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.
Read the detailed description
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.
- Keywords
- Psoriasis, Registry, Costa Rica, Generalized pustular psoriasis
- Medical subject headings
- Psoriasis
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 years
Clinical severity of generalized pustular psoriasis
Assessed by the Generalized Pustular Psoriasis Area and Severity Index (GPPASI) recorded during routine clinical evaluations.
Measured: 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.
Measured: 5 years
Change in Body Surface Area Affected
Change from baseline in percentage of Body Surface Area affected by psoriasis.
Measured: 5 years
Treatment-Related Adverse Events
Incidence of adverse events and serious adverse events considered related to systemic or biologic therapies.
Measured: 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.
Measured: 5 years
Secondary outcomes (2)
Clinical severity of generalized pustular psoriasis
Assessed by the PASI (Psoriasis Area Severity Index) recorded during routine clinical evaluations.
Measured: 5 years
Change in Psoriasis Area and Severity Index
Change from baseline in Psoriasis Area and Severity Index score as a measure of cutaneous disease severity.
Measured: 5 years
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 2031 (estimated)
- Study completionMay 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Generalized Pustular 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
- Prospective
- Enrolment
- 50 participants (estimated)
- Target duration
- 5 Years
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
- NCT07448428
- Sponsor's protocol ID
- CEC HCG 14-2025
- Status last verified
- Mar 2026
- First submitted
- 26 Feb 2026
- Last updated
- 9 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: According to protocol
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- National Registry of Patients With Generalized Pustular Psoriasis Treated Within the Costa Rican Social Security System
- ClinicalTrials.gov ID
- NCT07448428
- Acronym / sponsor ID
- CEC HCG 14-2025
- Keywords
- Psoriasis, Registry, Costa Rica, Generalized pustular psoriasis
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Caja Costarricense de Seguro SocialOther government
- Study start
- May 2026 (estimated)
- Primary completion
- May 2031 (estimated)
- Study completion
- May 2031 (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 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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
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
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.
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.
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.
Change in Body Surface Area Affected
Time frame: 5 years
Change from baseline in percentage of Body Surface Area affected by psoriasis.
Treatment-Related Adverse Events
Time frame: 5 years
Incidence of adverse events and serious adverse events considered related to systemic or biologic therapies.
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.
2 secondary outcomes
Clinical severity of generalized pustular psoriasis
Time frame: 5 years
Change in Psoriasis Area and Severity Index
Time frame: 5 years
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 9 Mar 2026.
- Individual participant dataSharing planned: No. According to 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 Generalized Pustular Psoriasis and Generalized Pustular Psoriasis (GPP), 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 4 inclusion and 3 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 9 Mar 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?
Disease course and evolution (time frame: 5 years). The study lists 6 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 9 Mar 2026.