Spanish Academy of Dermatology and Venereology Registry of Atopic Dermatitis Therapy (BIOBADATOP)

Fundación Academia Española de Dermatología

Status: Enrolling

Conditions: Dermatitis, Atopic

Treatments: Drug: Ciclosporin

Study type: Observational

Funder types: Other

Identifiers

NCT05674695

FAE-ATO-2018-02

Details and patient eligibility

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.

Enrollment: 2,500 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 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).
2. Diagnosis of atopic eczema in keeping with the UK/Irish diagnostic criteria.
3. Willingness to comply with all study requirements.

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).