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NCT Number: NCT07448389

Epidemiological, Clinical, Diagnostic, and Therapeutic Characteristics of Hansen's Disease in Costa Rica (2018-2025)

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.

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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

Ana L Rivera-Chavarria, Medical Doctor

SUB_INVESTIGATOR

Andres S Romero-Polini, Internist

SUB_INVESTIGATOR

Daniel E Barquero-Orias, Dermatologist

CONTACT

[email protected]

+506 83411026

Daniel E Barquero-Orias, Dermatologist

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Confirmed diagnosis of Hansen's disease.
  • Diagnosis between 1 January 2018 and 31 December 2025.
  • Any age or sex.
  • Available digital clinical record.
  • Case reported in national surveillance (VE-01).
  • Diagnosed or treated in Costa Rican public health institutions.

Exclusion criteria

  • Cases whose diagnosis was reviewed and reclassified as another disease.

Treatment and study plan

Primary outcomes

  1. Clinical Spectrum of Hansen Disease

    Time frame: 2018-2025

    Proportion (%) of patients classified according to Ridley-Jopling clinical spectrum (tuberculoid, borderline tuberculoid, mid-borderline, borderline lepromatous, lepromatous) and operational classification (paucibacillary or multibacillary).

  2. Frequency of Leprosy Reactions

    Time frame: 2018-2025

    Proportion (%) of patients who developed type 1 reaction (reversal reaction) and type 2 reaction (erythema nodosum leprosum), including number of episodes per patient.

  3. Disability Grade at Diagnosis

    Time frame: 2018-2025

    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.

Secondary outcomes

  1. Peripheral Nerve Involvement

    Time frame: 2018-2025

    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.

  2. Bacteriological Index

    Time frame: 2018-2015

    Continuous bacteriological index values obtained from slit-skin smear microscopy, when available.

  3. Time to Diagnosis

    Time frame: 2018-2025

    Time interval in months between onset of symptoms and confirmed diagnosis of Hansen disease.

  4. Treatment Regimens and Duration

    Time frame: 2018-2025

    Type of multidrug therapy regimen received (paucibacillary or multibacillary regimen) and total duration of treatment in months.

  5. Use of Immunomodulatory Treatment for Reactions

    Time frame: 2018-2025

    Proportion (%) of patients requiring systemic corticosteroids, thalidomide, or other immunomodulatory agents for management of leprosy reactions.

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

Retrospective Observational Study for the Epidemiological, Clinical, Diagnostic, and Therapeutic Characterization of Hansen's Disease With Confirmed Diagnosis in Costa Rica During 2018-2025

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
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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