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

Last updated: November 15, 2021
Sponsor: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Overall Status: Active - Recruiting

Phase

N/A

Condition

Dermatitis, Atopic

Allergy

Rash

Treatment

N/A

Clinical Study ID

NCT05078294
FIS-DER-2021-01
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Over 18 years.
  • Patients treated with any systemic therapy (other than topical therapy) according tocriteria clinical and routine clinical practice. Therefore, the treatments includedwill be: phototherapy, cyclosporine, methotrexate, azathioprine, mycophenolate,dupilumab, baricitinib, upadacitinib and tralokilumab.
  • Patients who grant informed consent.

Exclusion

Exclusion Criteria:

  • Patients who do not have the necessary comprehension capacity to understand and signthe informed consent.
  • Patients who, according to routine clinical practice, require only topical treatment.

Study Design

Total Participants: 300
Study Start date:
August 01, 2021
Estimated Completion Date:
November 01, 2024

Study 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).

Connect with a study center

  • Hospital General de Granollers

    Granollers, Barcelona 08402
    Spain

    Active - Recruiting

  • Hospital Universitario Puerta Real

    Puerto Real, Cádiz 11510
    Spain

    Active - Recruiting

  • Hospital Universitario Puerta de Hierro

    Majadahonda, Madrid 28222
    Spain

    Active - Recruiting

  • Hospital General Universitario de Alicante

    Alicante, 03010
    Spain

    Active - Recruiting

  • Hospital Sant Pau

    Barcelona, 08041
    Spain

    Active - Recruiting

  • Hospital Universitario Virgen del Rocío

    Sevilla, 41013
    Spain

    Active - Recruiting

  • Hospital Arnau de Vilanova

    Valencia, 46015
    Spain

    Active - Recruiting

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