Clinical trial NCT05674695: Spanish Academy of Dermatology and Venereology Registry of Atopic Dermatitis Therapy
Official title: Spanish Academy of Dermatology and Venereology Registry of Atopic Dermatitis Therapy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Dermatitis, Atopic
Lead sponsor: Fundación Academia Española de Dermatología
Sponsor class: OTHER
First posted: 2023-01-06
Enrollment: 2500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The population intends to be representative of all atopic dermatitis patients treated with systemic drugs in dermatology clinics in Spain.

Brief 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 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).

Primary outcomes:
measure: Rates of adverse events
timeFrame: through study completion, an average of 3 years
measure: Relative rate of adverse events
timeFrame: through study completion, an average of 3 years
Secondary outcomes:
measure: Change in Eczema Area and Severity Index (EASI)
timeFrame: Change between baseline and 6 months
measure: Change in Patient Oriented Eczema Measure (POEM)
timeFrame: Change between baseline and 6 months
Other outcomes:
Locations:
city: Badalona
country: Spain
facility: Hospital Universitari Germans Trias i Pujol
state: Barcelona
city: Alicante
country: Spain
facility: Hospital General Universitario de Alicante
city: Barcelona
country: Spain
facility: Hospital del Mar IMIM
city: Las Palmas
country: Spain
facility: Hospital Universitario de Gran Canaria Dr Negrín
city: Madrid
country: Spain
facility: Hospital Infanta Leonor
city: Madrid
country: Spain
facility: Hospital Universitario de la Princesa
city: Pontevedra
country: Spain
facility: Complexo Hospitalario Universitario de Pontevedra
city: Valencia
country: Spain
facility: Hospital Universitario y Politécnico la Fe
city: Zaragoza
country: Spain
facility: Hospital Miguel Servet
Study officials:
References: