An observational study in Leprosy, Hansen's Disease and Leprosy--Patients, sponsored by Caja Costarricense de Seguro Social. Not yet recruiting at 1 site in Costa Rica. Per ClinicalTrials.gov, last updated 2026-03-09.
Sponsored by Caja Costarricense de Seguro Social · Observational
The goal of this observational retrospective study is to characterize the epidemiologic, clinical, diagnostic, and therapeutic features of Hansen's disease cases in Costa Rica between 2018 and 2025. The main questions it aims to answer are:
What are the epidemiologic and clinical characteristics of confirmed Hansen's disease cases in Costa Rica?
What diagnostic methods, treatments, complications, and outcomes are observed in routine care?
All confirmed Hansen's disease cases recorded in national surveillance and with available clinical records during 2018-2025 will be included. Data will be obtained from electronic health records and Ministry of Health reports without participant contact.
Hansen's disease remains a low-incidence but persistent infectious condition in Costa Rica, with ongoing transmission foci, diagnostic delays, and disability despite its elimination as a public health problem. Standard management relies on WHO-recommended multidrug therapy (rifampicin, dapsone, clofazimine) with adjunctive corticosteroids or thalidomide for reactions. Unlike interventional studies evaluating new drugs or preventive strategies, this investigation is a retrospective national characterization of all confirmed cases diagnosed between 2018 and 2025. It does not introduce therapeutic modifications or prospective follow-up, but instead analyzes real-world epidemiologic distribution, clinical manifestations, diagnostic methods (bacilloscopy, histology, molecular tests), classification, treatment patterns, complications, disability, cure, and relapse using existing records. By focusing on nationwide surveillance data and routine care outcomes, the study provides population-level evidence on Hansen's disease in a post-elimination setting, distinguishing it from clinical trials or cohort studies of specific interventions.
52 studies on the registry are indexed under Leprosy; 13 are open to participants now.
Browse Leprosy studies →Caja Costarricense de Seguro Social is the lead sponsor of 12 studies on the registry; 7 are open to participants now.
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The study population comprises all confirmed Hansen's disease cases registered in Costa Rica between 2018 and 2025 with available clinical records in public health institutions. This retrospective national census (\~108 cases) includes patients of any age and sex across endemic regions and care levels. Data derive from electronic health records and Ministry of Health surveillance databases, reflecting real-world epidemiologic distribution, clinical presentation, diagnostic practices, treatment, complications, disability, and outcomes in routine care without participant interaction.
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Exclusion Criteria:
Clinical Spectrum of Hansen Disease
Proportion (%) of patients classified according to Ridley-Jopling clinical spectrum (tuberculoid, borderline tuberculoid, mid-borderline, borderline lepromatous, lepromatous) and operational classification (paucibacillary or multibacillary).
Time frame: 2018-2025
Frequency of Leprosy Reactions
Proportion (%) of patients who developed type 1 reaction (reversal reaction) and type 2 reaction (erythema nodosum leprosum), including number of episodes per patient.
Time frame: 2018-2025
Disability Grade at Diagnosis
Proportion (%) of patients with World Health Organization disability grade 0, 1, or 2 at diagnosis, based on neurological and ophthalmologic assessment documented in medical records.
Time frame: 2018-2025
Peripheral Nerve Involvement
Frequency and distribution of clinically affected peripheral nerves (ulnar, median, radial, common peroneal, posterior tibial, and facial nerves), including presence of nerve enlargement, pain, or sensory/motor deficit.
Time frame: 2018-2025
Bacteriological Index
Continuous bacteriological index values obtained from slit-skin smear microscopy, when available.
Time frame: 2018-2015
Time to Diagnosis
Time interval in months between onset of symptoms and confirmed diagnosis of Hansen disease.
Time frame: 2018-2025
Treatment Regimens and Duration
Type of multidrug therapy regimen received (paucibacillary or multibacillary regimen) and total duration of treatment in months.
Time frame: 2018-2025
Use of Immunomodulatory Treatment for Reactions
Proportion (%) of patients requiring systemic corticosteroids, thalidomide, or other immunomodulatory agents for management of leprosy reactions.
Time frame: 2018-2025
Plan to share: No — According to the protocol.
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This study is not yet recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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Caja Costarricense de Seguro Social