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The purpose of this study is to determine the efficacy results in terms of percentage improvement of the Eczema Area and Severity Index (EASI) as well as on the scale Patient Global Assessment (PGA) throughout the follow-up of patients undergoing subjected to systemic and/or biological treatments in conditions of usual clinical practice. Likewise, collect safety data, recording adverse events related to medication.
This is an observacional follow-up study, open-label (all people know the identity of the intervention), prospective (study following participants forward in time), multi-center study in adult participants with moderate to severe atopic dermatitis. A registration can also be made retrospective data from the patient's medical history.
Participants will be treated with one of this therapy (phototherapy, cyclosporine, methotrexate, azathioprine, mycophenolate, dupilumab, baricitinib, upadacitinib or tralokilumab).
A series of variables will be measured (basal surface area affected (BSA), Eczema Area and Severity Index (EASI), numbers of shoots, analytical determinations and current treatment and adverse effects occurred) in order to observe the changes in the improvement of the disease. Questionnaires will also be carried out to analyze whether the drug acts favorably in improving the disease. Questionnaires like Dermatology Life Quality Index (DLQI), Patient Global Assesment (PGA) and Patient Oriented SCOring Atopic Dermatitis (PO-SCORAD).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cases | Patients treated as monotherapy with phototherapy, cyclosporine, methotrexate, azathioprine, mycophenolate, dupilumab, baricitinib, upadacitinib, or tralokilumab for the treatment of moderate to severe atopic dermatitis. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of participants who showed a change in disease severity. | Percentage improvement in Eczema Area and Severity Index (EASI) throughout the follow-up of patients undergoing systemic treatments and/or biological. | Up to 30 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Medication-related adverse effect rate. | Number of adverse effects. | Up to 30 weeks |
| Evaluation of quality of life parameters. | Completion of the self-administered dermatology quality of life index questionnaire, which measures the quality of life of the patient. Numerical variable (range 0-30) obtained from a self-administered questionnaire already validated in Spanish, which measures the quality of life of surveyed, consisting of 10 questions. |
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Inclusion Criteria:
Exclusion Criteria:
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The study population would be patients older than 18 years who suffer from the disease and are being treated with a systemic therapy.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| José Juan Pereyra Rodríguez | Contact | 955 01 20 00 | josej.pereyra.sspa@juntadeandalucia.es | |
| Carlos García Pérez | Contact | 955 04 31 27 | administracion.eecc.hvm.sspa@juntadeandalucia.es |
| Name | Affiliation | Role |
|---|---|---|
| José Juan Pereyra Rodríguez | Hospitales Universitarios Virgen del Rocío | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital General de Granollers | Recruiting | Granollers | Barcelona | 08402 | 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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| Up to 30 weeks |
| Hospital Universitario Puerta Real | Recruiting | Puerto Real | Cádiz | 11510 | Spain |
|
| Hospital Universitario Puerta de Hierro | Recruiting | Majadahonda | Madrid | 28222 | Spain |
|
| Hospital General Universitario de Alicante | Recruiting | Alicante | 03010 | Spain |
|
| Hospital Sant Pau | Recruiting | Barcelona | 08041 | Spain |
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| Hospital Universitario Virgen del Rocío | Recruiting | Seville | 41013 | Spain |
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| Hospital Arnau de Vilanova | Recruiting | Valencia | 46015 | Spain |
|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |