Dermatitis, Atopic
Conditions
Brief summary
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.
Detailed description
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).
Interventions
None listed
Sponsors
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Over 18 years. * Patients treated with any systemic therapy (other than topical therapy) according to criteria clinical and routine clinical practice. Therefore, the treatments included will be: phototherapy, cyclosporine, methotrexate, azathioprine, mycophenolate, dupilumab, baricitinib, upadacitinib and tralokilumab. * Patients who grant informed consent.
Exclusion criteria
* Patients who do not have the necessary comprehension capacity to understand and sign the informed consent. * Patients who, according to routine clinical practice, require only topical treatment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants who showed a change in disease severity. | Up to 30 weeks | Percentage improvement in Eczema Area and Severity Index (EASI) throughout the follow-up of patients undergoing systemic treatments and/or biological. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Medication-related adverse effect rate. | Up to 30 weeks | Number of adverse effects. |
| Evaluation of quality of life parameters. | Up to 30 weeks | 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. |
Countries
Spain
Contacts
Primary ContactJosé Juan Pereyra Rodríguez
Backup ContactCarlos García Pérez
Outcome results
None listed