Spanish Academy of Dermatology and Venereology Registry of Atopic Dermatitis Therapy

Recruiting

• Conditions: Dermatitis, Atopic

• Registration Number: NCT05674695
• Lead Sponsor: Fundación Academia Española de Dermatología

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-01
• Status Verified: 2023-01
• Study First Submitted: 2023-01-02
• Study First Submitted QC: 2023-01-05
• Last Update Submitted: 2023-01-05
• Study First Posted: 2023-01-06
• Last Update Posted: 2023-01-06
• Primary Completion: 2029-01-01
• Study Completion: 2029-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2500

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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Relative rate of adverse events	through study completion, an average of 3 years	Compared to a standard drug ( such as cyclosporine). Crude and adjusted
Rates of adverse events	through study completion, an average of 3 years	For each drug or drug type

Secondary Outcome Measures

Name	Time	Method
Change in Eczema Area and Severity Index (EASI)	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)	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.

Trial Locations

Locations (9)

Hospital Universitario de la Princesa; 🇪🇸 Madrid, Spain

Hospital General Universitario de Alicante; 🇪🇸 Alicante, Spain

Hospital del Mar IMIM; 🇪🇸 Barcelona, Spain

Hospital Universitari Germans Trias i Pujol; 🇪🇸 Badalona, Barcelona, Spain

Hospital Universitario de Gran Canaria Dr Negrín; 🇪🇸 Las Palmas, Spain

Hospital Miguel Servet; 🇪🇸 Zaragoza, Spain

Complexo Hospitalario Universitario de Pontevedra; 🇪🇸 Pontevedra, Spain

Hospital Universitario y Politécnico la Fe; 🇪🇸 Valencia, Spain

Hospital Infanta Leonor; 🇪🇸 Madrid, Spain