National Registry of Patients With Atopic Dermatitis Under Treatment With Dupilumab and JAK Inhibitors Within the Costa Rican Social Security System
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change in atopic dermatitis severity over time
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Lack of sufficient clinical data for severity or treatment assessment
结局指标
主要结局
Change in atopic dermatitis severity over time
时间窗: 5 years
Measured using validated clinical severity scales EASI (Eczema Area and Severity Index)
Treatment patterns in moderate-to-severe atopic dermatitis
时间窗: 5 years
Type and duration of systemic or advanced therapies prescribed in real-world practice during the observation period.
Patient-reported quality of life
时间窗: 5 years
Change in Dermatology Life Quality Index (DLQI) scores over time during treatment.
次要结局
未报告次要终点
研究者
Daniel Barquero Orias
Principal Investigator
Caja Costarricense de Seguro Social