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LeprosyNCT07448389

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

An observational study of Leprosy and Hansen's Disease, run by Caja Costarricense de Seguro Social at 1 site in Costa Rica.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Leprosy, Hansen's Disease, Leprosy--Patients
How many people
130 participants
Where
1 siteCosta Rica
Study dates
May 2026to Dec 2026
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 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.

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Daniel E Barquero-Orias, Dermatologist contact

+506 83411026

debarque@ccss.sa.cr

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 E Barquero-Orias, Dermatologist

Other trials in Costa Rica

About this study

Official 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

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.

Read the detailed description

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.

Keywords
Leprosy, Costa Rica, Hansen's disease, Hansen
Medical subject headings
Leprosy, Leprosy, Lepromatous, Leprosy, Multibacillary

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: 2018-2025

  2. 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.

    Measured: 2018-2025

  3. 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.

    Measured: 2018-2025

Secondary outcomes (5)

  1. 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.

    Measured: 2018-2025

  2. Bacteriological Index

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

    Measured: 2018-2015

  3. Time to Diagnosis

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

    Measured: 2018-2025

  4. Treatment Regimens and Duration

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

    Measured: 2018-2025

  5. Use of Immunomodulatory Treatment for Reactions

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

    Measured: 2018-2025

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Mar 2026
  2. Study startMay 2026 (estimated)
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

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
Retrospective
Enrolment
130 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07448389
Sponsor's protocol ID
CEC HCG 12-2025
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 the protocol.

Questions about this trial

What is this clinical trial studying?

An observational study of Leprosy and Hansen's Disease, 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 6 inclusion and 1 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?

Clinical Spectrum of Hansen Disease (time frame: 2018-2025). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07448389.

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.

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