Spanish Academy of Dermatology and Venereology Registry of Atopic Dermatitis Therapy

NCT05674695 | Recruiting FDA Drug

• 1 other identifier: FAE-ATO-2018-02
• Study Type: observational
• Target: 2,500
• Locations: 1 country
• Sites: 9

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. 1.To assess short and long-term safety of systemic therapies (including phototherapy) for atopic eczema (pharmacovigilance).
2. 2.To assess short and long-term effectiveness of systemic therapies, providing a basis for shared decision making and guidelines.
3. 3.To assess short and long-term safety of topical therapies for atopic eczema.
4. 4.To assess effectiveness of different methods of care, including patient training.
5. 5.To describe atopic dermatitis comorbidities.

Conditions

Dermatitis, Atopic

Outcome Measures

Primary Outcomes (2)

• Rates of adverse events

  For each drug or drug type

  through study completion, an average of 3 years

• Relative rate of adverse events

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

  through study completion, an average of 3 years

Secondary Outcomes (2)

• Change in Eczema Area and Severity Index (EASI)

  Change between baseline and 6 months

• Change in Patient Oriented Eczema Measure (POEM)

  Change between baseline and 6 months

Interventions

Ciclosporin DRUG

Any systemic drug used for atopic dermatitis in clinical practice

Also known as: Methotrexate, Dupilumab, Corticosteroids, Omalizumab, Baricitinib, Upadacitinib, Tralokimumab, Topical corticosteroids

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Fundación Academia Española de Dermatología: lead

Study Sites (9)

Hospital Universitari Germans Trias i Pujol

Badalona, Barcelona, Spain

RECRUITING

Hospital General Universitario de Alicante

Alicante, Spain

RECRUITING

Hospital del Mar IMIM

Barcelona, Spain

RECRUITING

Hospital Universitario de Gran Canaria Dr Negrín

Las Palmas, Spain

RECRUITING

Hospital Infanta Leonor

Madrid, Spain

RECRUITING

Hospital Universitario de la Princesa

Madrid, Spain

RECRUITING

Complexo Hospitalario Universitario de Pontevedra

Pontevedra, Spain

RECRUITING

Hospital Universitario y Politécnico la Fe

Valencia, Spain

RECRUITING

Hospital Miguel Servet

Zaragoza, Spain

RECRUITING

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

Cyclosporine; Methotrexate; dupilumab; Adrenal Cortex Hormones; Omalizumab; baricitinib; upadacitinib

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Cyclosporins; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins; Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antibodies, Anti-Idiotypic; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Serum Globulins; Globulins

Central Study Contacts

Ignacio Garcia-Doval

CONTACT

34915 44 62 84; investigacion@aedv.es

Miguel Angel Descalzo Gallego

CONTACT

34915 44 62 84

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 2, 2023
• First Posted: January 6, 2023
• Study Start: January 1, 2019
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): January 1, 2029
• Last Updated: January 6, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

ES (9)