Spanish Academy of Dermatology and Venereology Registry of Atopic Dermatitis Therapy

Study Overview
=================
Brief Summary
-----------------
The Spanish Registry of Systemic therapy in atopic eczema, BIOBADATOP, assesses drug safety and treatment effectiveness as well as treatment impact on quality of life in children and adults with atopic eczema receiving systemic immuno-modulatory therapies in Spanish daily practice. The main objectives are: To assess short and long-term safety of systemic therapies (including phototherapy) for atopic eczema (pharmacovigilance). To assess short and long-term effectiveness of systemic therapies, providing a basis for shared decision making and guidelines. Secondary objectives are: To assess short and long-term safety of topical therapies for atopic eczema. To assess effectiveness of different methods of care, including patient training. To describe atopic dermatitis comorbidities.

Official Title
-----------------
Spanish Academy of Dermatology and Venereology Registry of Atopic Dermatitis Therapy

Conditions
-----------------
Dermatitis, Atopic

Intervention / Treatment
-----------------
* Drug: Ciclosporin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Paediatric and adult patients with atopic eczema who due to the severity of their disease and/or impact on quality of life are commencing on or switching to a specific systemic immuno-modulatory agent (e.g. CyA, AZA, MTX or new/biologic treatments) for the first time in their life (might have received others, but not this specific one). Diagnosis of atopic eczema in keeping with the UK/Irish diagnostic criteria. Willingness to comply with all study requirements. Exclusion Criteria: Insufficient understanding of the study by the patient and/or parent/guardian. Patients who are currently participating in a randomised clinical trial. Intention to move to a different geographical area in a short-term (next 3 months).
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Ciclosporin|Any systemic drug used for atopic dermatitis in clinical practice|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rates of adverse events | For each drug or drug type | through study completion, an average of 3 years | 
| Relative rate of adverse events | Compared to a standard drug ( such as cyclosporine). Crude and adjusted | through study completion, an average of 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Eczema Area and Severity Index (EASI) | EASI is used to measure the extent (area) and severity of atopic eczema.The minimum EASI score is 0 and the maximum EASI score is 72. A higher score means more severe or extended disease. | Change between baseline and 6 months | 
| Change in Patient Oriented Eczema Measure (POEM) | The Patient Oriented Eczema Measure (POEM) is a tool used for monitoring atopic eczema severity. It focuses on the illness as experienced by the patient. It ranges from 0 to 28, with higher scores meaning worse disease. | Change between baseline and 6 months |