RecruitingNCT05674695

Spanish Academy of Dermatology and Venereology Registry of Atopic Dermatitis Therapy


Sponsor

Fundación Academia Española de Dermatología

Enrollment

2,500 participants

Start Date

Jan 1, 2019

Study Type

OBSERVATIONAL

Conditions

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

Inclusion Criteria3

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

Exclusion Criteria3

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

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Interventions

DRUGCiclosporin

Any systemic drug used for atopic dermatitis in clinical practice


Locations(9)

Hospital Universitari Germans Trias i Pujol

Badalona, Barcelona, Spain

Hospital General Universitario de Alicante

Alicante, Spain

Hospital del Mar IMIM

Barcelona, Spain

Hospital Universitario de Gran Canaria Dr Negrín

Las Palmas, Spain

Hospital Infanta Leonor

Madrid, Spain

Hospital Universitario de la Princesa

Madrid, Spain

Complexo Hospitalario Universitario de Pontevedra

Pontevedra, Spain

Hospital Universitario y Politécnico la Fe

Valencia, Spain

Hospital Miguel Servet

Zaragoza, Spain

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NCT05674695


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