Dermatitis, AtopicBIOBADATOPNCT05674695
Spanish Academy of Dermatology and Venereology Registry of Atopic Dermatitis Therapy
An observational study of Dermatitis, Atopic, run by Fundación Academia Española de Dermatología at 9 sites in Spain.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Dermatitis, Atopic
- What is being tested?
- Ciclosporin
- How many people
- 2,500 participants
- Where
- 9 sitesSpain
- Study dates
- 1 Jan 2019to 1 Jan 2029
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The population intends to be representative of all atopic dermatitis patients treated with systemic drugs in dermatology clinics in Spain.
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Miguel Angel Descalzo Gallego contact
9 sites in 1 country
Spain9 sites, 9 recruiting
- Recruiting
Hospital General Universitario de Alicante
Alicante
Juan Francisco Silvestre Salvador
- Recruiting
Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona
Jose Manuel Carrascosa, MD
- Recruiting
Hospital del Mar IMIM
Barcelona
Ana María Gimenez-Arnau
- Recruiting
Hospital Universitario de Gran Canaria Dr Negrín
Las Palmas
Alicia González Quesada, MD
- Recruiting
Hospital Infanta Leonor
Madrid
Pablo De la Cueva Dobao
- Recruiting
Hospital Universitario de la Princesa
Madrid
Pablo Chicharro Manso
- Recruiting
Complexo Hospitalario Universitario de Pontevedra
Pontevedra
Ángeles Flórez
- Recruiting
Hospital Universitario y Politécnico la Fe
Valencia
Mercedes Rodríguez Älvarez
- Recruiting
Hospital Miguel Servet
Zaragoza
Yolanda Gilaberte
About this study
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:
Read more
- To assess short and long-term safety of systemic therapies (including phototherapy) for atopic eczema (pharmacovigilance).
- To assess short and long-term effectiveness of systemic therapies, providing a basis for shared decision making and guidelines.
Secondary objectives are:
- To assess short and long-term safety of topical therapies for atopic eczema.
- To assess effectiveness of different methods of care, including patient training.
- To describe atopic dermatitis comorbidities.
- Conditions
- Dermatitis, Atopic
- Being tested
- Ciclosporin
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CiclosporinDrug
Also called Methotrexate, Dupilumab, Corticosteroids, Omalizumab
Any systemic drug used for atopic dermatitis in clinical practice
What is being measured
The primary outcome is the main question the study is designed to answer.
Rates of adverse events
For each drug or drug type
Measured: through study completion, an average of 3 years
Relative rate of adverse events
Compared to a standard drug ( such as cyclosporine). Crude and adjusted
Measured: through study completion, an average of 3 years
Secondary outcomes (2)
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.
Measured: Change between baseline and 6 months
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.
Measured: Change between baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2023
- Study start1 Jan 2019
- Primary completion1 Jan 2029 (estimated)
- Study completion1 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dermatitis, AtopicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,500 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Fundación Academia Española de Dermatología
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05674695
- Sponsor's protocol ID
- FAE-ATO-2018-02
- Acronym
- BIOBADATOP
- Status last verified
- Jan 2023
- First submitted
- 2 Jan 2023
- Last updated
- 6 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spanish Academy of Dermatology and Venereology Registry of Atopic Dermatitis Therapy
- ClinicalTrials.gov ID
- NCT05674695
- Acronym / sponsor ID
- BIOBADATOP / FAE-ATO-2018-02
- Conditions
- Dermatitis, Atopic
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,500 participants (estimated)
- Lead sponsor
- Fundación Academia Española de DermatologíaUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Jan 2029 (estimated)
- Study completion
- 1 Jan 2029 (estimated)
- First posted
- 6 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To assess short and long-term safety of systemic therapies (including phototherapy) for atopic eczema (pharmacovigilance).
- To assess short and long-term effectiveness of systemic therapies, providing a basis for shared decision making and guidelines.
Secondary objectives are:
- To assess short and long-term safety of topical therapies for atopic eczema.
- To assess effectiveness of different methods of care, including patient training.
- To describe atopic dermatitis comorbidities.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The population intends to be representative of all atopic dermatitis patients treated with systemic drugs in dermatology clinics in Spain.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CiclosporinAlso: Methotrexate, Dupilumab, Corticosteroids, OmalizumabAny systemic drug used for atopic dermatitis in clinical practice | Drug | – |
Primary outcome
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
2 secondary outcomes
Change in Eczema Area and Severity Index (EASI)
Time frame: Change between baseline and 6 months
Change in Patient Oriented Eczema Measure (POEM)
Time frame: Change between baseline and 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Miguel Angel Descalzo Gallego contact
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dermatitis, Atopic, run by Fundación Academia Española de Dermatología at 9 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ignacio Garcia-Doval (34915 44 62 84, investigacion@aedv.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rates of adverse events (time frame: through study completion, an average of 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2023.