Spanish Academy of Dermatology and Venereology Registry of Atopic Dermatitis Therapy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ciclosporin.
- Who it may be relevant to
- Registry conditions: Dermatitis, Atopic. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Drug Ciclosporin
Any systemic drug used for atopic dermatitis in clinical practice
Primary outcome measures
- Rates of adverse events [Time frame: through study completion, an average of 3 years]
- Relative rate of adverse events [Time frame: through study completion, an average of 3 years]
Secondary outcome measures (2)
- Change in Eczema Area and Severity Index (EASI) [Time frame: Change between baseline and 6 months]
- Change in Patient Oriented Eczema Measure (POEM) [Time frame: Change between baseline and 6 months]
Eligibility criteria
Inclusion criteria
- 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 criteria
- 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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Spain · 9 centers
- Hospital Universitari Germans Trias i Pujol — Badalona
- Hospital General Universitario de Alicante — Alicante
- Hospital del Mar IMIM — Barcelona
- Hospital Universitario de Gran Canaria Dr Negrín — Las Palmas
- Hospital Infanta Leonor — Madrid
- Hospital Universitario de la Princesa — Madrid
- Complexo Hospitalario Universitario de Pontevedra — Pontevedra
- Hospital Universitario y Politécnico la Fe — Valencia
- … and 1 more center
Identifiers
NCT: NCT05674695 · FAE-ATO-2018-02