Spanish Academy of Dermatology and Venereology Registry of Atopic Dermatitis Therapy
Recruiting · NCT05674695 · Observational (researchers observe without assigning treatment) · Lead sponsor: Fundación Academia Española de Dermatología
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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).
Where it is running
9 locations listed.
- 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
- Hospital Universitari Germans Trias i Pujol - Badalona, Barcelona, Spain