LANDSCAPE - Demographic Characteristics and Treatment Profiles of Patients Affected by Inflammatory Skin Diseases (Psoriasis, Atopic Dermatitis, Alopecia Areata, Vitiligo, Hidradenitis Suppurativa) in Italian Clinical Practice
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20,000
- 试验地点
- 1
- 主要终点
- Patient Distribution by Disease Type
研究概览
简要总结
This multicenter retrospective observational registry study will collect existing clinical data from Italian centers to describe epidemiology, treatment patterns, clinical evolution, safety, and comorbidities in patients aged 12 years and older with psoriasis, atopic dermatitis, vitiligo, alopecia areata, or hidradenitis suppurativa.
详细描述
LANDSCAPE is a non-interventional, multicenter, retrospective disease registry based on routinely collected clinical data (electronic health records and available medical documentation) from participating Italian centers. Data will cover the period January 2016 to December 2025. The registry will support real-world evaluation of treatment patterns, effectiveness and safety outcomes, disease severity scores, persistence/switching, and associated comorbidities across psoriasis, atopic dermatitis, vitiligo, alopecia areata, and hidradenitis suppurativa. Data will be pseudonymized prior to entry into the EDC system. Patients who exercise the opt-out right will not be included.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Documented diagnosis of psoriasis, atopic dermatitis, vitiligo, alopecia areata, or hidradenitis suppurativa.
- •Age 12 years or older at the first recorded visit.
- •Eligible for or treated with systemic therapies.
- •At least one documented visit during January 2016 to December
- •No opt-out exercised.
排除标准
- •Opt-out exercised.
- •Medical records with insufficient data.
研究组 & 干预措施
Psoriasis Cohort
Adult patients (≥18 years) diagnosed with moderate-to-severe psoriasis according to clinical criteria, treated with systemic conventional and/or biologic therapies at participating Italian dermatology centers. No intervention is administered; data are collected retrospectively from medical records.
干预措施: Conventional Systemic Therapies (Drug)
Psoriasis Cohort
Adult patients (≥18 years) diagnosed with moderate-to-severe psoriasis according to clinical criteria, treated with systemic conventional and/or biologic therapies at participating Italian dermatology centers. No intervention is administered; data are collected retrospectively from medical records.
干预措施: Biologic Therapies (Drug)
Atopic Dermatitis Cohort
Adult patients (≥18 years) diagnosed with moderate-to-severe atopic dermatitis, treated with systemic conventional and/or biologic therapies at participating Italian dermatology centers. No intervention is administered; data are collected retrospectively from medical records.
干预措施: Conventional Systemic Therapies (Drug)
Atopic Dermatitis Cohort
Adult patients (≥18 years) diagnosed with moderate-to-severe atopic dermatitis, treated with systemic conventional and/or biologic therapies at participating Italian dermatology centers. No intervention is administered; data are collected retrospectively from medical records.
干预措施: Biologic Therapies (Drug)
Alopecia Areata Cohort
Adult patients (≥18 years) diagnosed with alopecia areata, treated with systemic therapies at participating Italian dermatology centers. No intervention is administered; data are collected retrospectively from medical records.
干预措施: Conventional Systemic Therapies (Drug)
Alopecia Areata Cohort
Adult patients (≥18 years) diagnosed with alopecia areata, treated with systemic therapies at participating Italian dermatology centers. No intervention is administered; data are collected retrospectively from medical records.
干预措施: Biologic Therapies (Drug)
Vitiligo Cohort
Adult patients (≥18 years) diagnosed with vitiligo, treated at participating Italian dermatology centers. No intervention is administered; data are collected retrospectively from medical records.
干预措施: Conventional Systemic Therapies (Drug)
Vitiligo Cohort
Adult patients (≥18 years) diagnosed with vitiligo, treated at participating Italian dermatology centers. No intervention is administered; data are collected retrospectively from medical records.
干预措施: Biologic Therapies (Drug)
Hidradenitis Suppurativa Cohort
Adult patients (≥18 years) diagnosed with hidradenitis suppurativa, treated with systemic conventional and/or biologic therapies at participating Italian dermatology centers. No intervention is administered; data are collected retrospectively from medical records
干预措施: Conventional Systemic Therapies (Drug)
Hidradenitis Suppurativa Cohort
Adult patients (≥18 years) diagnosed with hidradenitis suppurativa, treated with systemic conventional and/or biologic therapies at participating Italian dermatology centers. No intervention is administered; data are collected retrospectively from medical records
干预措施: Biologic Therapies (Drug)
结局指标
主要结局
Patient Distribution by Disease Type
时间窗: January 2016 to December 2025
Number and proportion of patients in each disease cohort (psoriasis, atopic dermatitis, alopecia areata, vitiligo, hidradenitis suppurativa).
Age at Treatment Initiation
时间窗: January 2016 to December 2025
Mean age (years) at first systemic treatment initiation, reported by disease cohort.
Sex Distribution
时间窗: January 2016 to December 2025
Proportion of male and female patients (percentage) by disease cohort.
次要结局
- Treatment Patterns and Therapeutic Sequences(January 2016 to December 2025)
- Treatment Persistence and Drug Survival(January 2016 to December 2025)
- Disease Severity Assessment Over Time(January 2016 to December 2025)