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.
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
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.
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
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.
- Conditions
- Leprosy, Hansen's Disease, Leprosy--Patients, Lepromatous Leprosy, Leprosy, Multibacillary, Leprosy Neuropathy
- 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.
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
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
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)
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
Bacteriological Index
Continuous bacteriological index values obtained from slit-skin smear microscopy, when available.
Measured: 2018-2015
Time to Diagnosis
Time interval in months between onset of symptoms and confirmed diagnosis of Hansen disease.
Measured: 2018-2025
Treatment Regimens and Duration
Type of multidrug therapy regimen received (paucibacillary or multibacillary regimen) and total duration of treatment in months.
Measured: 2018-2025
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.
- First posted4 Mar 2026
- Study startMay 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LeprosyStudies 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
- Retrospective
- Enrolment
- 130 participants (estimated)
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
- 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.