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NCT Number: NCT07448363

Atopic Dermatitis Treated With Dupilumab and JAK Inhibitors in Costa Rica

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Abrocitinib

Drug

This registry specifically focuses on patients with moderate-to-severe atopic dermatitis receiving systemic immunosuppressive or biologic therapies in real-world clinical practice in Costa Rica. Unlike clinical trials or other dermatologic registries, this study captures routine-care treatment patterns, including conventional systemic agents and newer targeted biologics used according to physician judgment without protocol-mandated interventions. The registry uniquely characterizes disease severity, treatment response, and quality-of-life outcomes in the Costa Rican population across multiple centers, enabling evaluation of effectiveness, safety, and persistence of advanced therapies in everyday practice rather than controlled research settings.

Upadacitinib

Drug

This registry specifically focuses on patients with moderate-to-severe atopic dermatitis receiving systemic immunosuppressive or biologic therapies in real-world clinical practice in Costa Rica. Unlike clinical trials or other dermatologic registries, this study captures routine-care treatment patterns, including conventional systemic agents and newer targeted biologics used according to physician judgment without protocol-mandated interventions. The registry uniquely characterizes disease severity, treatment response, and quality-of-life outcomes in the Costa Rican population across multiple centers, enabling evaluation of effectiveness, safety, and persistence of advanced therapies in everyday practice rather than controlled research settings.

Baricitinib

Drug

This registry specifically focuses on patients with moderate-to-severe atopic dermatitis receiving systemic immunosuppressive or biologic therapies in real-world clinical practice in Costa Rica. Unlike clinical trials or other dermatologic registries, this study captures routine-care treatment patterns, including conventional systemic agents and newer targeted biologics used according to physician judgment without protocol-mandated interventions. The registry uniquely characterizes disease severity, treatment response, and quality-of-life outcomes in the Costa Rican population across multiple centers, enabling evaluation of effectiveness, safety, and persistence of advanced therapies in everyday practice rather than controlled research settings.

dupilumab

Biological

This registry specifically focuses on patients with moderate-to-severe atopic dermatitis receiving systemic immunosuppressive or biologic therapies in real-world clinical practice in Costa Rica. Unlike clinical trials or other dermatologic registries, this study captures routine-care treatment patterns, including conventional systemic agents and newer targeted biologics used according to physician judgment without protocol-mandated interventions. The registry uniquely characterizes disease severity, treatment response, and quality-of-life outcomes in the Costa Rican population across multiple centers, enabling evaluation of effectiveness, safety, and persistence of advanced therapies in everyday practice rather than controlled research settings.

Primary outcomes

  1. Change in atopic dermatitis severity over time

    Time frame: 5 years

    Measured using validated clinical severity scales EASI (Eczema Area and Severity Index)

  2. 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.

  3. 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.

  4. Patient-reported quality of life

    Time frame: 5 years

    Change in Dermatology Life Quality Index (DLQI) scores over time during treatment.

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

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

Important dates

Study start
2026
Primary completion
2031
Study completion
2031
First posted
Mar 4, 2026
Registry last updated
Apr 8, 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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