Spanish Academy of Dermatology and Venereology Registry of Atopic Dermatitis Therapy (BIOBADATOP)

January 5, 2023 updated by: Fundación Academia Española de Dermatología

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

2500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Miguel Angel Descalzo Gallego
  • Phone Number: 34915 44 62 84

Study Locations

  • Spain
      • Alicante, Spain
        • Recruiting
        • Hospital General Universitario de Alicante
        • Contact:
          • Juan Francisco Silvestre Salvador
      • Barcelona, Spain
        • Recruiting
        • Hospital del Mar IMIM
        • Contact:
          • Ana María Gimenez-Arnau
      • Las Palmas, Spain
        • Recruiting
        • Hospital Universitario de Gran Canaria Dr Negrin
        • Contact:
          • Alicia González Quesada, MD
      • Madrid, Spain
        • Recruiting
        • Hospital Universitario de la Princesa
        • Contact:
          • Pablo Chicharro Manso
      • Madrid, Spain
        • Recruiting
        • Hospital Infanta Leonor
        • Contact:
          • Pablo De la Cueva Dobao
      • Pontevedra, Spain
        • Recruiting
        • Complexo Hospitalario Universitario de Pontevedra
        • Contact:
          • Ángeles Flórez
      • Valencia, Spain
        • Recruiting
        • Hospital Universitario Y Politecnico La Fe
        • Contact:
          • Mercedes Rodríguez Älvarez
      • Zaragoza, Spain
        • Recruiting
        • Hospital Miguel Servet
        • Contact:
          • Yolanda Gilaberte
    • Barcelona
      • Badalona, Barcelona, Spain
        • Recruiting
        • Hospital Universitari Germans Trias I Pujol
        • Contact:
          • Jose Manuel Carrascosa, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rates of adverse events
Time Frame: through study completion, an average of 3 years
For each drug or drug type
through study completion, an average of 3 years
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
through study completion, an average of 3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 between baseline and 6 months
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.
Change between baseline and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundación Academia Española de Dermatología

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2019

Primary Completion (Anticipated)

January 1, 2029

Study Completion (Anticipated)

January 1, 2029

Study Registration Dates

First Submitted

January 2, 2023

First Submitted That Met QC Criteria

January 5, 2023

First Posted (Estimate)

January 6, 2023

Study Record Updates

Last Update Posted (Estimate)

January 6, 2023

Last Update Submitted That Met QC Criteria

January 5, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FAE-ATO-2018-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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