Results in Real Clinical Practice of Treatment of Moderate-severe Atopic Dermatitis

  • End date
    Nov 1, 2024
  • participants needed
  • sponsor
    Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Updated on 26 November 2021
topical agents


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).

Condition Dermatitis, Atopic, ATOPIC DERMATITIS, Dermatite Atopique, Eczema (Atopic Dermatitis), Atopic Dermatitis, Eczéma (Dermatite Atopique)
Clinical Study IdentifierNCT05078294
SponsorFundación Pública Andaluza para la gestión de la Investigación en Sevilla
Last Modified on26 November 2021


Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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