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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:
Secondary objectives are:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ciclosporin | Drug | Any systemic drug used for atopic dermatitis in clinical practice |
|
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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The population intends to be representative of all atopic dermatitis patients treated with systemic drugs in dermatology clinics in Spain.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ignacio Garcia-Doval | Contact | 34915 44 62 84 | investigacion@aedv.es | |
| Miguel Angel Descalzo Gallego | Contact | 34915 44 62 84 |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitari Germans Trias i Pujol | Recruiting | Badalona | Barcelona | Spain |
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| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
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| ID | Term |
|---|---|
| D016572 | Cyclosporine |
| D008727 | Methotrexate |
| C582203 | dupilumab |
| D000305 | Adrenal Cortex Hormones |
| D000069444 | Omalizumab |
| C000596027 | baricitinib |
| C000613732 | upadacitinib |
| ID | Term |
|---|---|
| D003524 | Cyclosporins |
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
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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 |
| Hospital General Universitario de Alicante | Recruiting | Alicante | Spain |
|
| Hospital del Mar IMIM | Recruiting | Barcelona | Spain |
|
| Hospital Universitario de Gran Canaria Dr Negrín | Recruiting | Las Palmas | Spain |
|
| Hospital Infanta Leonor | Recruiting | Madrid | Spain |
|
| Hospital Universitario de la Princesa | Recruiting | Madrid | Spain |
|
| Complexo Hospitalario Universitario de Pontevedra | Recruiting | Pontevedra | Spain |
|
| Hospital Universitario y Politécnico la Fe | Recruiting | Valencia | Spain |
|
| Hospital Miguel Servet | Recruiting | Zaragoza | Spain |
|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D010455 |
| Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000630 | Aminopterin |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D000888 | Antibodies, Anti-Idiotypic |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D012712 | Serum Globulins |
| D005916 | Globulins |