Spanish Academy of Dermatology and Venereology Registry of Atopic Dermatitis Therapy

Dermatitis, Atopic Clinical Trial

— BIOBADATOP  

Official title:

Spanish Academy of Dermatology and Venereology Registry of Atopic Dermatitis Therapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05674695
• Other study ID #: FAE-ATO-2018-02
• Status: Recruiting
• Start date: January 1, 2019
• Est. completion date: January 1, 2029

Study information

• Verified date: January 2023
• Source: Fundación Academia Española de Dermatología
• Contact: Ignacio Garcia-Doval
• Phone: 34915 44 62 84
• Email: investigacion[@]aedv.es
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2500
• Est. completion date: January 1, 2029
• Est. primary completion date: January 1, 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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).

Related Conditions & MeSH terms

• Dermatitis
• Dermatitis, Atopic

Intervention

Drug:
• Ciclosporin
Any systemic drug used for atopic dermatitis in clinical practice

Locations

Country	Name	City	State
Spain	Hospital General Universitario de Alicante	Alicante
Spain	Hospital Universitari Germans Trias i Pujol	Badalona	Barcelona
Spain	Hospital del Mar IMIM	Barcelona
Spain	Hospital Universitario de Gran Canaria Dr Negrín	Las Palmas
Spain	Hospital Infanta Leonor	Madrid
Spain	Hospital Universitario de la Princesa	Madrid
Spain	Complexo Hospitalario Universitario de Pontevedra	Pontevedra
Spain	Hospital Universitario y Politécnico la Fe	Valencia
Spain	Hospital Miguel Servet	Zaragoza

Sponsors (1)

Lead Sponsor	Collaborator
Fundación Academia Española de Dermatología

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rates of adverse events	For each drug or drug type	through study completion, an average of 3 years
Primary	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	Change in Eczema Area and Severity Index (EASI)	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 between baseline and 6 months
Secondary	Change in Patient Oriented Eczema Measure (POEM)	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.	Change between baseline and 6 months