Atopic DermatitisNCT07448363
Atopic Dermatitis Treated With Dupilumab and JAK Inhibitors in Costa Rica
An observational study of Atopic Dermatitis and Atopic Dermatitis (AD), run by Caja Costarricense de Seguro Social at 1 site in Costa Rica.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Atopic Dermatitis, Atopic Dermatitis (AD), Atopic Dermatitis (Eczema)
- What is being tested?
- Abrocitinib, Upadacitinib and Baricitinib
- How many people
- 50 participants
- Where
- 1 siteCosta Rica
- Study dates
- May 2026to May 2031
- How long will I take part?
- 5 Years
- 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 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.
Who may be able to join
- 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
Who cannot join
- Lack of sufficient clinical data for severity or treatment assessment
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
About this study
Official title: 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?
Read more
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.
Read the 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.
- Conditions
- Atopic Dermatitis, Atopic Dermatitis (AD), Atopic Dermatitis (Eczema), Atopic Dermatitis Patients, Atopic Dermatitis / Eczema, Atopic Dermatitis, Unspecified
- Being tested
- Abrocitinib, Upadacitinib, Baricitinib, Dupilumab
- Keywords
- Registry, Dupilumab, Abrocitinib, Upadacitinib, JAK-inhibitor, Atopic dermatitis, Baricitinib
- Medical subject headings
- Dermatitis, Atopic, Eczema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AbrocitinibDrug
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.
UpadacitinibDrug
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.
BaricitinibDrug
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.
DupilumabBiological
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in atopic dermatitis severity over time
Measured using validated clinical severity scales EASI (Eczema Area and Severity Index)
Measured: 5 years
Change in atopic dermatitis severity over time
Measured using the validated clinical severity scale SCORAD (SCORing Atopic Dermatitis) from baseline through follow-up visits during routine care.
Measured: 5 years
Treatment patterns in moderate-to-severe atopic dermatitis
Type and duration of systemic or advanced therapies prescribed in real-world practice during the observation period.
Measured: 5 years
Patient-reported quality of life
Change in Dermatology Life Quality Index (DLQI) scores over time during treatment.
Measured: 5 years
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 completionMay 2031 (estimated)
- Study completionMay 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies 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
- Prospective
- Enrolment
- 50 participants (estimated)
- Target duration
- 5 Years
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
- NCT07448363
- Sponsor's protocol ID
- CEC HCG 04-2026
- Status last verified
- Apr 2026
- First submitted
- 26 Feb 2026
- Last updated
- 8 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: According to protocol
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- National Registry of Patients With Atopic Dermatitis Under Treatment With Dupilumab and JAK Inhibitors Within the Costa Rican Social Security System
- ClinicalTrials.gov ID
- NCT07448363
- Acronym / sponsor ID
- CEC HCG 04-2026
- Conditions
- Atopic Dermatitis, Atopic Dermatitis (AD), Atopic Dermatitis (Eczema), Atopic Dermatitis Patients, Atopic Dermatitis / Eczema, Atopic Dermatitis, Unspecified
- Keywords
- Registry, Dupilumab, Abrocitinib, Upadacitinib, JAK-inhibitor, Atopic dermatitis, Baricitinib
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Caja Costarricense de Seguro SocialOther government
- Study start
- May 2026 (estimated)
- Primary completion
- May 2031 (estimated)
- Study completion
- May 2031 (estimated)
- First posted
- 4 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- Lack of sufficient clinical data for severity or treatment assessment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AbrocitinibThis 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. | Drug | – |
| UpadacitinibThis 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. | Drug | – |
| BaricitinibThis 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. | Drug | – |
| DupilumabThis 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. | Biological | – |
Primary outcome
Change in atopic dermatitis severity over time
Time frame: 5 years
Measured using validated clinical severity scales EASI (Eczema Area and Severity Index)
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.
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.
Patient-reported quality of life
Time frame: 5 years
Change in Dermatology Life Quality Index (DLQI) scores over time during treatment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2026.
- Individual participant dataSharing planned: No. According to protocol
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atopic Dermatitis and Atopic Dermatitis (AD), 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 5 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 8 Apr 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?
Change in atopic dermatitis severity over time (time frame: 5 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Apr 2026.