Spanish Academy of Dermatology and Venereology Registry of Atopic Dermatitis Therapy

Last updated: January 5, 2023
Sponsor: Fundación Academia Española de Dermatología
Overall Status: Active - Recruiting

Phase

N/A

Condition

Eczema (Atopic Dermatitis - Pediatric)

Dermatitis, Atopic

Allergy

Treatment

N/A

Clinical Study ID

NCT05674695
FAE-ATO-2018-02
  • All Genders

Study Summary

The Spanish Registry of Systemic therapy in atopic eczema, BIOBADATOP, assesses drug safety and treatment effectiveness as well as treatment impact on quality of life in children and adults with atopic eczema receiving systemic immuno-modulatory therapies in Spanish daily practice.

The main objectives are:

  1. To assess short and long-term safety of systemic therapies (including phototherapy) for atopic eczema (pharmacovigilance).

  2. To assess short and long-term effectiveness of systemic therapies, providing a basis for shared decision making and guidelines.

Secondary objectives are:

  1. To assess short and long-term safety of topical therapies for atopic eczema.

  2. To assess effectiveness of different methods of care, including patient training.

  3. To describe atopic dermatitis comorbidities.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Paediatric and adult patients with atopic eczema who due to the severity of theirdisease and/or impact on quality of life are commencing on or switching to a specificsystemic immuno-modulatory agent (e.g. CyA, AZA, MTX or new/biologic treatments) forthe first time in their life (might have received others, but not this specific one).
  2. Diagnosis of atopic eczema in keeping with the UK/Irish diagnostic criteria.
  3. Willingness to comply with all study requirements.

Exclusion

Exclusion Criteria:

  1. Insufficient understanding of the study by the patient and/or parent/guardian.
  2. Patients who are currently participating in a randomised clinical trial.
  3. Intention to move to a different geographical area in a short-term (next 3 months).

Study Design

Total Participants: 2500
Study Start date:
January 01, 2019
Estimated Completion Date:
January 01, 2029

Connect with a study center

  • Hospital Universitari Germans Trias i Pujol

    Badalona, Barcelona
    Spain

    Active - Recruiting

  • Hospital General Universitario de Alicante

    Alicante,
    Spain

    Active - Recruiting

  • Hospital del Mar IMIM

    Barcelona,
    Spain

    Active - Recruiting

  • Hospital Universitario de Gran Canaria Dr Negrín

    Las Palmas,
    Spain

    Active - Recruiting

  • Hospital Infanta Leonor

    Madrid,
    Spain

    Active - Recruiting

  • Hospital Universitario de la Princesa

    Madrid,
    Spain

    Active - Recruiting

  • Complexo Hospitalario Universitario de Pontevedra

    Pontevedra,
    Spain

    Active - Recruiting

  • Hospital Universitario y Politécnico la Fe

    Valencia,
    Spain

    Active - Recruiting

  • Hospital Miguel Servet

    Zaragoza,
    Spain

    Active - Recruiting

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