Atopic Dermatitis Treated With Dupilumab and JAK Inhibitors in Costa Rica

April 2, 2026 updated by: Daniel Barquero Orias, Caja Costarricense de Seguro Social

National Registry of Patients With Atopic Dermatitis Under Treatment With Dupilumab and JAK Inhibitors Within the Costa Rican Social Security System

The goal of this observational registry is to characterize the clinical features, severity, treatments, and outcomes of patients with atopic dermatitis in Costa Rica receiving systemic and advanced therapies in routine clinical practice. The main questions it aims to answer are:

What are the demographic and clinical characteristics of patients with moderate-to-severe atopic dermatitis treated in specialized dermatology centers in Costa Rica?

What treatments are used in real-world practice and how do they impact disease severity and patient-reported outcomes over time?

Participants with atopic dermatitis receiving systemic or advanced therapies as part of their usual medical care will be followed longitudinally, with collection of clinical severity scores, treatment patterns, and outcomes during routine visits.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a national, multicenter, observational registry of patients with atopic dermatitis treated in dermatology referral centers in Costa Rica. The registry aims to document demographic characteristics, disease history, severity, comorbidities, treatment patterns, and longitudinal outcomes in patients receiving systemic immunosuppressants, biologic agents, or other advanced therapies in routine clinical practice.

Data will be collected prospectively and retrospectively from medical records and routine clinical assessments, including validated severity indices (e.g., EASI, SCORAD, DLQI), treatment exposure, adverse events, and therapeutic response over time. The registry will allow evaluation of real-world effectiveness, safety, and treatment persistence, as well as characterization of moderate-to-severe atopic dermatitis in the Costa Rican population.

This registry does not modify clinical management; all treatments are prescribed according to physician judgment and standard care.

Study Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Daniel E Barquero-Orias, Dermatologist
  • Phone Number: +506 83411026
  • Email: debarque@ccss.sa.cr

Study Locations

  • Costa Rica
    • Provincia de San José
      • San José, Provincia de San José, Costa Rica, 40901
        • Caja Costarricense del Seguro Social
        • Contact:
          • Daniel E Barquero-Orias, Dermatologist
          • Phone Number: +506 83411026
          • Email: debarque@ccss.sa.cr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study population includes pediatric and adult patients with moderate-to-severe atopic dermatitis treated in dermatology referral centers in Costa Rica who require systemic immunomodulatory or biologic therapy. These patients represent individuals with more severe or refractory disease seen in specialized care settings, often with significant disease burden, chronic course, and impact on quality of life. The registry captures real-world clinical practice across participating centers and reflects the national population receiving advanced atopic dermatitis therapies.

Description

Inclusion Criteria:

  • Clinical diagnosis of atopic dermatitis according to accepted diagnostic criteria
  • Moderate-to-severe disease requiring systemic or advanced therapy
  • Receiving systemic immunosuppressive, biologic, or other advanced treatment as part of routine care
  • Evaluated in participating dermatology centers in Costa Rica
  • Available clinical records with baseline and follow-up information

Exclusion Criteria:

  • Lack of sufficient clinical data for severity or treatment assessment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in atopic dermatitis severity over time
Time Frame: 5 years
Measured using validated clinical severity scales EASI (Eczema Area and Severity Index)
5 years
Change in atopic dermatitis severity over time
Time Frame: 5 years
Measured using the validated clinical severity scale SCORAD (SCORing Atopic Dermatitis) from baseline through follow-up visits during routine care.
5 years
Treatment patterns in moderate-to-severe atopic dermatitis
Time Frame: 5 years
Type and duration of systemic or advanced therapies prescribed in real-world practice during the observation period.
5 years
Patient-reported quality of life
Time Frame: 5 years
Change in Dermatology Life Quality Index (DLQI) scores over time during treatment.
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Caja Costarricense de Seguro Social

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2026

Primary Completion (Estimated)

May 1, 2031

Study Completion (Estimated)

May 1, 2031

Study Registration Dates

First Submitted

February 26, 2026

First Submitted That Met QC Criteria

March 2, 2026

First Posted (Actual)

March 4, 2026

Study Record Updates

Last Update Posted (Actual)

April 8, 2026

Last Update Submitted That Met QC Criteria

April 2, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEC HCG 04-2026

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

According to protocol

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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