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

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

Non Recruiting
18 years and older
All
Phase N/A

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Overview

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.

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).

Eligibility

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.

Study details
    Dermatitis
    Atopic

NCT05078294

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

20 August 2025

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

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The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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