Spanish Academy of Dermatology and Venereology Registry of Atopic Dermatitis Therapy

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.

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Key information

Conditions

Dermatitis, Atopic Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Universitari Germans Trias i Pujol, Badalona, Barcelona, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Ciclosporin

Drug

Any systemic drug used for atopic dermatitis in clinical practice

Other names: Methotrexate, Dupilumab, Corticosteroids, Omalizumab, Baricitinib, Upadacitinib, Tralokimumab, Topical corticosteroids

Primary outcomes

Rates of adverse events

Time frame: through study completion, an average of 3 years

For each drug or drug type
Relative rate of adverse events

Time frame: through study completion, an average of 3 years

Compared to a standard drug ( such as cyclosporine). Crude and adjusted

Secondary outcomes

Change in Eczema Area and Severity Index (EASI)

Time frame: Change between baseline and 6 months

EASI is used to measure the extent (area) and severity of atopic eczema.The minimum EASI score is 0 and the maximum EASI score is 72. A higher score means more severe or extended disease.
Change in Patient Oriented Eczema Measure (POEM)

Time frame: Change between baseline and 6 months

The Patient Oriented Eczema Measure (POEM) is a tool used for monitoring atopic eczema severity. It focuses on the illness as experienced by the patient. It ranges from 0 to 28, with higher scores meaning worse disease.

Study contacts

Contact information is provided by the study sponsor or research team.

Ignacio Garcia-Doval

CONTACT

[email protected]

34915 44 62 84

Miguel Angel Descalzo Gallego

CONTACT

34915 44 62 84

Sponsors and collaborators

Lead sponsor

Fundación Academia Española de Dermatología

Other

Registry information

Acronym: BIOBADATOP

Important dates

Study start: 2019
Primary completion: 2029
Study completion: 2029
First posted: Jan 6, 2023
Registry last updated: Jan 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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